UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 20-5894890 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 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 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 September 30, 2021 ☐ TRANSITION RE ...

CorMedix Inc. (NASDAQ:CRMD) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors, IR Khoso Baluch - CEO Phoebe Mounts - EVP and General Counsel Matt David - EVP and CFO Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Securities Chad Messer - Needham & Company Operator Greetings and welcome to the CorMedix Inc. Second Quarter 2021 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question ...

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, 2021 ☐ 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) (State or Other Jurisdiction of Incorpo ...

Financial Data and Key Metrics Changes - The net loss for Q1 2021 was approximately $7.2 million or $0.20 per share, compared to a loss of $5.6 million or $0.21 per share in Q1 2020, indicating an increase in net loss due to higher expenses related to DEFENCATH preparations [45][46] - Operating expenses increased approximately 29% to $7.2 million in Q1 2021 from $5.6 million in Q1 2020, with R&D expenses rising by 7% to $2.6 million and SG&A expenses increasing by 45% to $4.6 million [46][47] - Cash and equivalents stood at $81.2 million as of March 31, 2021, providing the company with the flexibility to address manufacturing issues and prepare for market entry [49] Business Line Data and Key Metrics Changes - The focus remains on the commercial launch of DEFENCATH, a catheter lock solution aimed at reducing catheter-related bloodstream infections in hemodialysis patients [8][51] - The company is also preparing for label expansion of DEFENCATH for use in TPN and oncology patients, indicating a strategic move to broaden its market reach [14][40] Market Data and Key Metrics Changes - The hemodialysis market represents a significant opportunity, with a large unmet medical need for antimicrobial solutions to prevent CRBSIs, as there are currently no approved pharmacological agents in the U.S. [52] - The potential for DEFENCATH to address life-threatening infections is emphasized, particularly in the context of the ongoing COVID-19 pandemic [85] Company Strategy and Development Direction - The company aims to resolve third-party manufacturing deficiencies, expand connections within the hemodialysis community, and prepare for the successful launch of DEFENCATH upon FDA approval [53] - There is a commitment to exploring label expansions for DEFENCATH beyond hemodialysis, targeting pediatric patients and those undergoing chemotherapy [40][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of DEFENCATH to meet significant clinical needs and emphasized the importance of reducing infection rates in patients [52][85] - The company is optimistic about the FDA's recognition of DEFENCATH's potential and is preparing for a resubmission of the NDA in Q4 2021 [27][30] Other Important Information - The company has appointed a new Chief Commercial Officer, Tom Nusbickel, to enhance its commercial strategy as it approaches the launch of DEFENCATH [9][11] - The FDA has provided guidance on remote interactive evaluations for pre-approval inspections, which may facilitate the review process [32][66] Q&A Session Summary Question: Confirmation on the manual extraction study and statistical analysis plan - Management confirmed the successful completion of the study as required by the FDA [56] Question: Timeline for additional in-process qualification work - The company has agreed on a plan with its CMO to resolve deficiencies and generate additional data required by the FDA [57] Question: Key activities ahead of the launch and marketing message for DEFENCATH - Management indicated that further details on the launch strategy would be provided as the new CCO familiarizes himself with existing plans [58][60] Question: Expected response timeline from the FDA after NDA resubmission - The timeline for FDA review will be determined at the time of NDA resubmission, with no specific information available at this time [64] Question: Discussions regarding virtual inspections with the FDA - The company has not had discussions regarding virtual inspections, as the guidance was released after their meeting with the FDA [66] Question: Need for re-approval of the CMO for pediatric studies - The label expansion will be filed as a supplement to the NDA, and the manufacturing facility would be subject to routine inspections by the FDA [69] Question: Clarification on the qualification processes and NDA submission timeline - Management explained the complexity of the manufacturing process and the need for robust data to meet FDA requirements [73][75]

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the company's unaudited financial statements and management's analysis of its financial condition [Item 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, statements of cash flows, and accompanying notes, providing a detailed financial overview for the reported periods [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20March%2031%2C%202021%20and%20December%2031%2C%202020) This chapter presents the company's financial position, detailing assets, liabilities, and equity at specific points in time | Metric | March 31, 2021 ($) | December 31, 2020 ($) | Change ($) | Change (%) | | :------------- | :------------- | :---------------- | :--------- | :--------- | | Total Assets | $84,258,811 | $49,308,303 | $34,950,508 | 70.88% | | Cash & Cash Equivalents | $76,214,620 | $41,905,469 | $34,309,151 | 81.87% | | Metric | March 31, 2021 ($) | December 31, 2020 ($) | Change ($) | Change (%) | | :---------------- | :------------- | :---------------- | :--------- | :--------- | | Total Liabilities | $3,943,744 | $5,085,291 | $(1,141,547) | -22.45% | | Metric | March 31, 2021 ($) | December 31, 2020 ($) | Change ($) | Change (%) | | :---------------------- | :------------- | :---------------- | :--------- | :--------- | | Total Stockholders' Equity | $80,315,067 | $44,223,012 | $36,092,055 | 81.61% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202021%20and%202020) This chapter outlines the company's financial performance, including revenues, expenses, and net loss, over specific reporting periods | Metric | 2021 ($) | 2020 ($) | Change ($) | Change (%) | | :------------------------- | :------------ | :------------ | :------------ | :--------- | | Revenue (Net Sales) | 88,261 | 74,054 | 14,207 | 19.18% | | Cost of Sales | (61,339) | (48,517) | (12,822) | 26.43% | | Gross Profit | 26,922 | 25,537 | 1,385 | 5.42% | | Research and Development | (2,636,332) | (2,472,117) | (164,215) | 6.64% | | Selling, General and Administrative | (4,601,108) | (3,165,168) | (1,435,940) | 45.37% | | Total Operating Expenses | (7,237,440) | (5,637,285) | (1,600,155) | 28.39% | | Loss From Operations | (7,210,518) | (5,611,748) | (1,598,770) | 28.49% | | Net Loss | (7,216,938) | (5,557,567) | (1,659,371) | 29.86% | | Comprehensive Loss | (7,220,118) | (5,564,088) | (1,656,030) | 29.76% | | Net Loss Per Common Share – Basic and Diluted | (0.20) | (0.21) | 0.01 | -4.76% | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202021%20and%202020) This chapter details the changes in the company's equity accounts, reflecting stock transactions, compensation, and net loss over the period | Item | Amount ($) | | :---------------------------------------- | :------------ | | Balance at December 31, 2020 | 44,223,012 | | Stock issued in connection with ATM sale | 41,455,630 | | Stock issued in connection with warrants exercised, cash | 124,929 | | Stock-based compensation | 1,731,614 | | Net loss | (7,216,938) | | Balance at March 31, 2021 | 80,315,067 | - Net proceeds from ATM common stock sales: - Q1 2021: **$41,456,000** from 3,737,862 shares - Q1 2020: **$2,470,000** from 368,144 shares[94](index=94&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202021%20and%202020) This chapter summarizes the cash inflows and outflows from operating, investing, and financing activities, showing changes in liquidity | Activity | 2021 ($) | 2020 ($) | Change ($) | Change (%) | | :---------------------------------------- | :------------ | :------------ | :------------ | :--------- | | Net cash used in operating activities | (6,690,812) | (7,966,926) | 1,276,114 | -16.02% | | Net cash (used in) provided by investing activities | (526,018) | 985,418 | (1,511,436) | -153.38% | | Net cash provided by financing activities | 41,580,559 | 2,834,664 | 38,745,895 | 1366.89% | | Net increase (decrease) in cash and cash equivalents | 34,356,166 | (4,149,025) | 38,505,191 | -927.93% | | Cash, cash equivalents and restricted cash – End of Period | 76,452,949 | 12,376,162 | 64,076,787 | 517.75% | - Financing Activities Breakdown (Three Months Ended March 31, 2021): - Proceeds from ATM program: **$41,455,630** (vs. **$2,469,937** in 2020) - Proceeds from warrant exercise: **$124,929** (vs. **$411,751** in 2020)[22](index=22&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This chapter provides detailed explanations and additional information supporting the condensed consolidated financial statements [Note 1 — Organization, Business and Basis of Presentation](index=8&type=section&id=Note%201%20%E2%80%94%20Organization%2C%20Business%20and%20Basis%20of%20Presentation) This note describes the company's business, primary product focus, regulatory status, and the basis for financial statement presentation - Primary product focus is **DefenCath™/Neutrolin®**, an anti-infective solution for preventing catheter-related infections and thrombosis in CVC patients (hemodialysis, TPN, oncology)[25](index=25&type=chunk)[139](index=139&type=chunk) - **FDA** issued a **Complete Response Letter (CRL)** for **DefenCath's NDA** in March 2021, citing manufacturing facility concerns and requiring a manual extraction study. The study has been successfully completed, and the company is addressing manufacturing qualification issues for **NDA** resubmission[32](index=32&type=chunk)[33](index=33&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) - **FDA** did not request additional clinical data on efficacy or safety. Initial approval will be for a limited population (kidney failure patients receiving chronic hemodialysis via CVC) under the **LPAD pathway**, with potential for **10.5 years** of marketing exclusivity[37](index=37&type=chunk)[38](index=38&type=chunk)[149](index=149&type=chunk)[164](index=164&type=chunk) - **Neutrolin** is commercially launched in Germany (Dec 2013) and registered in certain EU and Middle Eastern countries. Label expansion includes oncology, intensive/critical care, and total parenteral nutrition patients. Saudi Arabia registration expired in Sept 2019, renewal pending[41](index=41&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) - Company is pursuing additional **DefenCath** indications and pre-clinical research for taurolidine in rare orphan pediatric tumors (neuroblastoma, **Orphan Drug Designation** in Feb 2018) and medical devices (wound closure, surgical meshes, hydrogels)[39](index=39&type=chunk)[40](index=40&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[165](index=165&type=chunk) - COVID-19 pandemic may negatively affect program timelines, business, financial conditions, and results of operations due to disruptions in supply chains, clinical trials, and regulatory processes[46](index=46&type=chunk)[157](index=157&type=chunk) [Note 2 — Summary of Significant Accounting Policies](index=12&type=section&id=Note%202%20%E2%80%94%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles, estimates, and judgments used in preparing the financial statements - Accumulated deficit of **$224.7 million** as of March 31, 2021. Sufficient cash, cash equivalents, and short-term investments to fund operations into the second half of 2022. Continued operations depend on raising additional capital[51](index=51&type=chunk)[52](index=52&type=chunk) | Metric | March 31, 2021 ($) | December 31, 2020 ($) | | :----------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $76,214,620 | $41,905,469 | | Restricted cash | 238,329 | 191,314 | | Total cash, cash equivalents and restricted cash | $76,452,949 | $42,096,783 | | Category | March 31, 2021 ($) | December 31, 2020 ($) | | :------------------- | :------------- | :---------------- | | Money Market Funds | $17,661,060 | $3,182,689 | | Corporate Securities | $3,657,835 | $3,564,499 | | Commercial Paper | $1,299,522 | $879,573 | | Total | $22,618,417 | $7,626,761 | | Category | March 31, 2021 ($) | December 31, 2020 ($) | | :---------------- | :------------- | :---------------- | | Finished goods | $259,240 | $317,733 | | Inventory reserve | (174,169) | (174,169) | | Total | $85,071 | $143,564 | | Category | March 31, 2021 ($) | December 31, 2020 ($) | | :---------------------------- | :------------- | :---------------- | | Professional and consulting fees | $175,075 | $146,129 | | Accrued payroll and payroll taxes | 1,048,359 | 2,490,441 | | Clinical trial related | 1,000 | 2,187 | | Manufacturing development related | 97,970 | 143,780 | | Other | 114,306 | 141,814 | | Total | $1,436,710 | $2,924,351 | - Potentially dilutive shares (preferred stock, RSUs, warrants, stock options) were excluded from diluted EPS calculation as their effect would be anti-dilutive[88](index=88&type=chunk)[89](index=89&type=chunk) [Note 3 — Stockholders' Equity](index=18&type=section&id=Note%203%20%E2%80%94%20Stockholders'%20Equity) This note details changes in common stock, warrants, and stock-based compensation, impacting the company's equity structure - Common Stock Sales (ATM Program): - Q1 2021: **3,737,862 shares** sold, net proceeds of **$41,456,000** - Q1 2020: **368,144 shares** sold, net proceeds of **$2,470,000** - As of March 31, 2021, no available balance under ATM program; **$50.0 million** available under shelf registration[94](index=94&type=chunk) - Warrant Exercises: - Q1 2021: **23,796 shares** issued for cash (**$125,000** net proceeds); 70,269 shares issued for cashless exercise of 95,286 warrants - Q1 2020: **91,500 shares** issued for cash (**$412,000** net proceeds) - Outstanding warrants (March 31, 2021): **64,066** with weighted average exercise price of **$5.25** and **1.36 years** remaining contractual life[95](index=95&type=chunk)[96](index=96&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - Stock-Based Compensation: - Q1 2021: **$1,732,000** expense - Q1 2020: **$670,000** expense - Unrecognized compensation expense: **$8,080,000**, to be recognized over 1.6 years - Stock options granted in Q1 2021: **1,122,200 shares**, weighted average exercise price **$8.70**[100](index=100&type=chunk)[101](index=101&type=chunk) | Metric | Shares | Weighted Average Exercise Price ($/share) | Aggregate Intrinsic Value ($) | | :---------------------------------------- | :---------- | :------------------------------ | :------------------------ | | Outstanding at beginning of period | 2,447,687 | $7.22 | $3,872,092 | | Granted | 1,122,200 | $8.70 | $1,757,174 | | Forfeited | (21,876) | $4.71 | - | | Expired | (6,000) | $10.50 | - | | Outstanding at end of period | 3,542,011 | $7.70 | $10,048,396 | | Exercisable at end of period | 1,671,558 | $8.34 | $4,378,889 | [Note 4 — Commitments and Contingencies](index=21&type=section&id=Note%204%20%E2%80%94%20Commitments%20and%20Contingencies) This note discloses the company's legal proceedings, security deposits, and in-licensing agreements, outlining potential future obligations - Patent Infringement (Prosl European Patent EP 1 814 562 B1): Filed against TauroPharm in Germany (Sept 2014). **EPO** revoked the patent as invalid; company has appealed[109](index=109&type=chunk)[116](index=116&type=chunk) - Utility Model Infringement (DE 20 2005 022 124 U1): German PTO affirmed invalidity. Company withdrew complaint in April 2020[112](index=112&type=chunk)[115](index=115&type=chunk) - Unfair Competition Proceedings: Filed against TauroPharm (Jan 2015) for unauthorized use of proprietary information. District Court dismissed complaint (Dec 2018); company appealed (Jan 2019). Expert opinion not in company's favor; oral hearing postponed to June 18, 2021, due to COVID-19[119](index=119&type=chunk) - Security Deposits: Approximately **$136,000** in restricted cash as of March 31, 2021, for legal fees in these proceedings[120](index=120&type=chunk) - In-Licensing (NDP License Agreement): Exclusive worldwide licenses for antimicrobial catheter lock solutions. Max aggregate cash payments remaining: **$2,500,000**[123](index=123&type=chunk)[124](index=124&type=chunk) [Note 5 — Leases](index=25&type=section&id=Note%205%20%E2%80%94%20Leases) This note provides information on the company's operating lease liabilities, right-of-use assets, and future lease payment obligations | Metric | March 31, 2021 ($) | December 31, 2020 ($) | | :----------------------------------- | :------------- | :---------------- | | Total operating lease liability | $1,007,000 | $1,033,000 | | Operating lease liabilities, short-term | $113,000 | $109,000 | | Operating lease liabilities, net of current portion | $894,000 | $924,000 | | Metric | March 31, 2021 ($) | December 31, 2020 ($) | | :----------------- | :------------- | :---------------- | | Operating ROU assets | $987,000 | $1,015,000 | - Cash Paid for Leases: - Q1 2021: **$52,000** - Q1 2020: **$2,000**[132](index=132&type=chunk) - Weighted Average Remaining Lease Term: **6.5 years** (March 31, 2021). Weighted Average Discount Rate: **9%** (March 31, 2021)[132](index=132&type=chunk) | Year | Amount ($) | | :-------------------- | :---------- | | 2021 (remaining) | 149,000 | | 2022 | 200,000 | | 2023 | 202,000 | | 2024 | 205,000 | | 2025 | 208,000 | | 2026 and thereafter | 380,000 | | Total future minimum lease payments | 1,344,000 | | Less imputed interest | (337,000) | | Total | 1,007,000 | [Note 6 — Concentrations](index=26&type=section&id=Note%206%20%E2%80%94%20Concentrations) This note identifies significant concentrations in accounts receivable and revenue, highlighting customer dependency - Accounts Receivable Concentration (March 31, 2021): Two customers accounted for **65%** and **34%** of net accounts receivable[134](index=134&type=chunk) - Revenue Concentration (Three Months Ended March 31, 2021): Three customers accounted for **47%**, **28%**, and **15%** of total sales[134](index=134&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance, liquidity, and future outlook, emphasizing the development of DefenCath, ongoing regulatory challenges, and the need for additional capital to fund operations and commercialization efforts [Overview](index=27&type=section&id=Overview) This overview introduces **CorMedix** as a biopharmaceutical company, its primary product **DefenCath**, and key operational challenges including regulatory hurdles and the impact of COVID-19 - **CorMedix** is a biopharmaceutical company focused on **DefenCath™/Neutrolin®** for the prevention and treatment of infectious and inflammatory diseases, primarily catheter-related infections[138](index=138&type=chunk)[139](index=139&type=chunk) - **FDA** issued a **Complete Response Letter (CRL)** in March 2021 for **DefenCath NDA**, citing concerns at the third-party manufacturing facility and requiring a manual extraction study. The company is addressing these issues for resubmission[145](index=145&type=chunk)[146](index=146&type=chunk) - Initial **FDA** approval for **DefenCath** is expected for a limited population (kidney failure patients on chronic hemodialysis via CVC) under the **LPAD pathway**. The company is also exploring other taurolidine applications and faces ongoing legal disputes and COVID-19 related operational risks[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk)[165](index=165&type=chunk) - **Neutrolin** is commercially launched in Germany and registered in certain EU and Middle Eastern countries. Saudi Arabia registration expired in September 2019, renewal pending[154](index=154&type=chunk)[155](index=155&type=chunk)[156](index=156&type=chunk) - The COVID-19 pandemic has caused and may continue to cause disruptions to clinical trials, supply chains, regulatory timelines, and overall business operations[157](index=157&type=chunk) - Accumulated deficit of approximately **$224.7 million** as of March 31, 2021; operations funded primarily through debt and equity financings[158](index=158&type=chunk)[159](index=159&type=chunk) [Financial Operations Overview](index=30&type=section&id=Financial%20Operations%20Overview) This section outlines the company's revenue generation, expense categories, and financial policies related to foreign currency and interest - Revenue has not been substantial since inception; operations funded primarily through debt and equity financings[159](index=159&type=chunk) - Research and Development (R&D) expense includes internal costs, payments to CROs, CMOs, investigative sites, consultants, technology/IP license costs, manufacturing development, personnel expenses, regulatory filings, preclinical/clinical trials, and allocated facilities expenses. All R&D is expensed as incurred[160](index=160&type=chunk) - Selling, General and Administrative (SG&A) expense includes commercial personnel, medical education, marketing, advertising, salaries, stock-based compensation, facility costs, promotional expenses, and professional fees[167](index=167&type=chunk) - Foreign currency exchange transaction gain (loss) results from re-measuring transactions in non-functional currencies; unrealized movements on long-term intercompany loans are recorded in other comprehensive income (loss)[168](index=168&type=chunk) - Interest income is earned on cash, cash equivalents, and short-term investments. Interest expense is incurred on convertible debt, amortization of debt discount, and financing expenditures[170](index=170&type=chunk)[171](index=171&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the period, detailing changes in revenue, cost of sales, operating expenses, and interest income - Revenue for Q1 2021 was **$88,000**, an increase of **19%** from **$74,000** in Q1 2020, primarily due to increased sales in the Middle East[169](index=169&type=chunk)[173](index=173&type=chunk) - Cost of sales increased by **24%** to **$61,000** in Q1 2021 from **$49,000** in Q1 2020, mainly due to higher material costs from increased Middle East sales[169](index=169&type=chunk)[174](index=174&type=chunk) - Research and Development expense increased by **7%** to **$2,636,000** in Q1 2021, driven by higher personnel expenses and non-cash stock-based compensation, partially offset by decreases in **DefenCath** manufacturing costs and clinical trial expenses due to the LOCK-IT-100 trial closing[169](index=169&type=chunk)[175](index=175&type=chunk) - Selling, General and Administrative expense increased by **45%** to **$4,601,000** in Q1 2021, primarily due to non-cash stock-based compensation, marketing research for **DefenCath**, and personnel expenses, partially offset by lower recruitment and legal fees[169](index=169&type=chunk)[176](index=176&type=chunk) - Interest income decreased by **95%** to **$3,000** in Q1 2021 from **$64,000** in Q1 2020, attributable to lower average interest-bearing cash equivalents and short-term investments[169](index=169&type=chunk)[178](index=178&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's sources and uses of cash, its current liquidity position, and future capital requirements for operations and commercialization - Sources of Liquidity: Primarily debt and equity financings. Q1 2021 saw net proceeds of **$41,456,000** from ATM common stock sales and **$125,000** from warrant exercises[181](index=181&type=chunk)[185](index=185&type=chunk) - Net Cash Used in Operating Activities: Decreased by **$1,276,000** to **$6,691,000** in Q1 2021, mainly due to higher non-cash stock-based compensation and lower increase in prepaid expenses, offset by increased net loss and higher decrease in accrued expenses[183](index=183&type=chunk) - Net Cash Provided by (Used in) Investing Activities: **$526,000** used in Q1 2021 (vs. **$985,000** provided in Q1 2020), driven by lower investment in short-term investments[184](index=184&type=chunk) - Total cash and short-term investments: **$81.2 million** as of March 31, 2021 (vs. **$46.3 million** at Dec 31, 2020). **$50.0 million** available under current shelf registration; no ATM program balance[186](index=186&type=chunk) - Estimates sufficient cash to fund operations into the second half of 2022, considering initial **DefenCath** commercial launch preparations. Additional capital will be required for pre-commercial launch, R&D, and general operations; no assurance of availability on acceptable terms[187](index=187&type=chunk)[191](index=191&type=chunk) [Contractual Obligations](index=35&type=section&id=Contractual%20Obligations) This section details the company's significant contractual obligations, specifically its operating lease agreement for office space - The company has a seven-year operating lease agreement for office space in New Jersey, which commenced in September 2020, with a monthly average cost of approximately **$17,000**[192](index=192&type=chunk) [Critical Accounting Policies](index=35&type=section&id=Critical%20Accounting%20Policies) This section confirms that there have been no significant changes to the company's critical accounting policies during the reported quarter - No significant changes to critical accounting policies for Q1 2021 compared to the 2020 Annual Report on Form 10-K[194](index=194&type=chunk) [Recently Adopted Accounting Pronouncements](index=36&type=section&id=Recently%20Adopted%20Accounting%20Pronouncements) This section reports on the adoption of new accounting standards and their impact on the company's financial statements - Adopted **ASU 2019-12** (income taxes) on January 1, 2021, with no material impact on condensed consolidated financial statements[196](index=196&type=chunk) [Off-Balance Sheet Arrangements](index=36&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements that could materially affect the company's financial position - The company has no off-balance sheet arrangements[197](index=197&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company reported no material market risk disclosures for the period - No material market risk disclosures[199](index=199&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, and there were no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=36&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as assessed by management - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2021, ensuring timely and accurate reporting of information[201](index=201&type=chunk) [Changes in Internal Control Over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section reports on any material changes in the company's internal control over financial reporting during the quarter - No material changes in internal control over financial reporting during Q1 2021[202](index=202&type=chunk) [PART II OTHER INFORMATION](index=37&type=section&id=PART%20II%20OTHER%20INFORMATION) This part includes legal proceedings, risk factors, and exhibits, providing additional non-financial and forward-looking information [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) This section provides an update on the ongoing patent infringement and unfair competition lawsuits in Germany against TauroPharm. The Prosl European Patent was revoked by the EPO but is under appeal, while the Utility Model was affirmed invalid. The unfair competition case, alleging unauthorized use of proprietary information, is still pending, with an expert opinion not favoring the company and a hearing postponed due to COVID-19 - Patent Infringement (Prosl European Patent EP 1 814 562 B1): Filed against TauroPharm in Germany (Sept 2014). **EPO** revoked the patent as invalid in Nov 2017; company has appealed[204](index=204&type=chunk)[209](index=209&type=chunk) - Utility Model Infringement (DE 20 2005 022 124 U1): German PTO affirmed invalidity in Sept 2019. Company withdrew complaint in April 2020 as the Utility Model expired in Nov 2015[208](index=208&type=chunk) - Unfair Competition Proceedings: Filed against TauroPharm (Jan 2015) for unauthorized use of proprietary information. District Court dismissed complaint (Dec 2018); company appealed (Jan 2019). Expert opinion did not favor the company; oral hearing postponed to June 18, 2021, due to COVID-19[211](index=211&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the significant and ongoing risks posed by the COVID-19 pandemic, including potential disruptions to preclinical studies, clinical trials, manufacturing, regulatory review, and overall business operations, as well as volatility in stock trading prices and difficulties in raising capital - COVID-19 Pandemic Impact: May materially and adversely impact business, preclinical studies, and clinical trials, leading to delays at vendors, difficulties in patient enrollment, clinical site initiation, and staff recruitment[212](index=212&type=chunk)[213](index=213&type=chunk)[214](index=214&type=chunk)[216](index=216&type=chunk) - Potential disruptions include increased patient withdrawals, diversion of healthcare resources, interruption of key clinical trial activities, and delays in **FDA**/regulatory authority operations. Supply chain disruptions, staffing shortages, and production slowdowns at CMOs are also risks[216](index=216&type=chunk) - The pandemic's future impact is highly uncertain, affecting business, preclinical studies, and clinical trials. High volatility in common stock trading prices may lead to difficulties in raising capital or unfavorable terms[217](index=217&type=chunk)[218](index=218&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications, employment agreements, and XBRL financial data - Includes Executive Employment Agreement, Certifications of Principal Executive and Financial Officers (Sections 302 and 906 of **Sarbanes-Oxley Act**), and XBRL financial data[221](index=221&type=chunk) [SIGNATURES](index=40&type=section&id=SIGNATURES) This section confirms the official signing and submission of the report by the authorized executive - The report was signed by Khoso Baluch, Chief Executive Officer, on May 13, 2021[226](index=226&type=chunk)

& CorMedix™ Corporate Presentation April 2021 DefenCath™: A potentially new standard-of-care in the prevention of catheter related blood stream infections Forward-Looking Statements This presentation contains certain statements that constitute forward-looking statements within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. These statements are not guarantees of future performance a ...

CorMedix Inc. (NASDAQ:CRMD) Q4 2020 Earnings Conference Call March 30, 2021 4:30 PM ET Company Participants Dan Ferry - Investor Relations Khoso Baluch - Chief Executive Officer Phoebe Mounts - Executive Vice President & General Counsel Matt David - Executive Vice President & Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Securities Chad Messer - Needham & Company Andrew D'Silva - B. Riley & Company Operator Greetings. Welcome to the CorMedix Fourth Quar ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2020 OR ☐ 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) | --- | --- | |-------- ...

CorMedix Inc. (NASDAQ:CRMD) Q3 2020 Earnings Conference Call November 5, 2020 4:30 PM ET Company Participants Dan Ferry - Investor Relations Khoso Baluch - Chief Executive Officer Phoebe Mounts - Executive Vice President and General Counsel Matt David - Executive Vice President and Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Operator Greetings and welcome to the CorMedix Inc. Third Quarter 2020 Earnings Call. [Operator Instructions] As a reminder, this conference is be ...

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 September 30, 2020 ☐ 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) | --- | --- | |------------------- ...