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CorMedix Inc. (CRMD)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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7.82+0.17 (+2.22%)
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Neutralpattern detected
Previous Close7.65
Open7.63
Bid7.70 x 1200
Ask7.85 x 800
Day's Range7.21 - 7.86
52 Week Range3.07 - 18.80
Volume771,326
Avg. Volume1,333,150
Market Cap297.349M
Beta (5Y Monthly)2.38
PE Ratio (TTM)N/A
EPS (TTM)-0.77
Earnings DateMay 10, 2021 - May 14, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est20.90
  • CorMedix Has Meeting With FDA on DefenCath Catheter Lock Solution NDA
    GlobeNewswire

    CorMedix Has Meeting With FDA on DefenCath Catheter Lock Solution NDA

    BERKELEY HEIGHTS, N.J., April 14, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that it has met with the US Food and Drug Administration (FDA) to discuss proposed resolutions for the deficiencies identified in the Complete Response Letter (CRL) to CorMedix and the Post-Application Action Letter received by the third-party manufacturer (CMO) from FDA for the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution). Representatives from both CorMedix and the CMO participated in the meeting with FDA to ensure that there is alignment on addressing the Agency’s concerns. There is now an agreed upon protocol for the manual extraction study identified in the CRL that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials. As anticipated previously, CorMedix expects to be able to complete this requirement in the next several weeks. Addressing FDA’s concerns regarding the qualification of the filling operation may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath. CorMedix and the CMO are currently evaluating available data to determine if additional process qualification will be needed with subsequent validation to address these issues. The FDA stated that the review timeline would be determined when the NDA resubmission is received and 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 on-site evaluation in the next review cycle, if the FDA determines it will do an onsite evaluation. CorMedix and the CMO continue to work closely to ensure that the identified deficiencies are resolved prior to resubmission of the DefenCath NDA. CorMedix will provide updates on the timeline as resolution of the deficiencies proceeds. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan FerryManaging DirectorLifeSci Advisors(617) 430-7576

  • CorMedix Inc. to Present at the 20th Annual Needham Virtual Healthcare Conference
    GlobeNewswire

    CorMedix Inc. to Present at the 20th Annual Needham Virtual Healthcare Conference

    BERKELEY HEIGHTS, N.J., April 07, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that CorMedix management will present a corporate overview at the 20th Annual Needham Virtual Healthcare Conference taking place on April 12 – 15, 2021. 20th Annual Needham Virtual Healthcare Conference (virtual)Date: Wednesday, April 14thTime: 4:30 pm Eastern TimeWebcast: https://wsw.com/webcast/needham107/crmd/2235068 About CorMedixCorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product, which provides an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors617-430-7576

  • CorMedix Inc. Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
    GlobeNewswire

    CorMedix Inc. Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

    Conference Call Scheduled for Today at 4:30 p.m. Eastern TimeBERKELEY HEIGHTS, N.J., March 30, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent business developments. Recent Corporate Highlights: CorMedix announced in early March 2021 that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath in its present form. FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility, and has requested a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from vials.CorMedix continues to work closely with our third-party manufacturing facility and is planning for a meeting with the FDA in mid-April to obtain agreement on the adequacy of our proposed plans for resolution of the deficiencies.CorMedix transitioned to Nasdaq in early February 2021, which has become the primary trading platform for biopharmaceutical peers and other growth companies.CorMedix has strengthened its balance sheet via equity financing activity over the past year and early 2021.CorMedix has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer substantially all of the $1.3 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2020, for approximately $1.3 million in net proceeds. Closing is anticipated in 2Q of 2021. Khoso Baluch, CorMedix CEO commented, “While we were disappointed that the DefenCath NDA was not approved at its PDUFA date, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath closer to regulatory approval.” 4th Quarter 2020 Financial Highlights For the fourth quarter of 2020, CorMedix recorded a net loss of $6.1 million, or $0.19 per share, compared with a net loss of $5.3 million, or $0.21 per share, in the fourth quarter of 2019, an increase in net loss of $0.8 million. The increase in net loss in the fourth quarter of 2020 compared with 2019 was primarily driven by increases in employee costs and market research costs. Operating expenses during the fourth quarter of 2020 were $6.1 million, compared with $5.4 million in the fourth quarter of 2019, an increase of approximately $0.7 million. Full Year 2020 Financial Highlights For the year ended December 31, 2020, CorMedix recorded a net loss of $22.0 million, or $0.77 per share, compared with a net loss during the year ended December 31, 2019 of $16.4 million before recognition of deemed dividends, or $0.68 per share, an increase in net loss of $5.6 million. The increase in net loss was driven primarily by increases in operating expenses. Operating expenses during the year ended December 31, 2020 amounted to $27.3 million compared with $20.9 million during the comparable period in 2019, an increase of $6.4 million, or 30%, due to a 21% increase in R&D expense and 41% increase in SG&A expense. Total cash on hand and short-term investments as of December 31, 2020 amounted to $46.3 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at year end plus the $41.5 million in net proceeds from ATM issuances since the beginning of 2021, it has sufficient resources to fund operations at least into the second half of 2022. Conference Call Information The management team of CorMedix will host a conference call and webcast today, March 30, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows: Tuesday, March 30th @ 4:30pm ET Domestic: 877-423-9813 International: 201-689-8573 Conference ID: 13715664 Webcast: Webcast Link About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product, which provides an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisors(617) 430-7576 CORMEDIX INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(Audited) For the Three Months Ended December 31, For the Years Ended December 31, 2020 2019 2020 2019 Revenue: Net sales$55,713 $24,779 $239,231 $283,266 Cost of sales (57,233) (46,125) (204,846) (373,234)Gross profit (1,520) (21,346) 34,385 (89,968)Operating Expenses: Research and development (2,294,430) (2,677,007) (13,377,193) (11,052,903)Selling, general and administrative (3,788,690) (2,677,470) (13,877,944) (9,865,005)Total Operating Expenses (6,083,120) (5,354,477) (27,255,137) (20,917,908)Income (loss) From Operations (6,084,640) (5,375,823) (27,220,752) (21,007,876)Other Income (Expense): Interest income 2,940 75,788 116,065 322,668 Foreign exchange transaction loss 76 2,126 (59,165) (21,156)Change in fair value of derivative liability - - - - Interest and amortization expense (5,322) (6,276) (33,226) (787,488)Total Other Income (Expense) (2,306) 71,638 23,674 (485,976)Net Loss Before Income Taxes (6,086,946) (5,304,185) (27,197,078) (21,493,852)Tax benefit - - 5,169,395 5,060,778 Net Loss (6,086,946) (5,304,185) (22,027,683) (16,433,074)Other Comprehensive Income (Loss) 2,347 (4,745) 4,749 735 Comprehensive Income (Loss)$(6,084,599) $(5,308,930) $(22,022,934) $(16,432,339)Net loss (6,086,946) (5,304,185) (22,027,683) (16,433,074)Deemed dividend as a result of warrant modification - - - (369,500)Deemed dividend as a result of exchange of convertible note and Series C-2, Series D and Series F preferred stock, related party - - - (26,733,098)Net Loss Attributable to Common Shareholders (6,086,946) (5,304,185) (22,027,683) (43,535,672)Net Income (Loss) Per Common Share – Basic and Diluted$(0.19) $(0.21) $(0.77) $(1.80)Weighted Average Common Shares Outstanding – Basic and Diluted 32,402,336 25,665,619 28,561,963 24,152,088 CORMEDIX INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS(Audited) December 31, December 31, 2020 2019 ASSETS Cash, cash equivalents and restricted cash$42,096,783 $16,525,187 Short-term investments$4,444,072 $11,984,157 Total Assets $49,308,303 $29,475,910 Total Liabilities $5,085,291 $5,829,650 Accumulated deficit$(217,448,855) $(195,421,172)Total Stockholders’ Equity $44,223,012 $23,646,260 CORMEDIX INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF CASH FLOWS(Audited) Years Ended December 31, 2020 2019 Cash Flows From Operating Activities: Net loss$(22,027,683) $(16,433,074)Net cash used in operating activities (21,967,638) (15,052,024)Cash Flows Used In Investing Activities: Net cash used in (provided by) investing activities 7,426,176 (12,020,459)Cash Flows From Financing Activities: Net cash provided by financing activities 40,099,866 25,804,362 Foreign exchange effects on cash 13,192 (2,015)Net Increase (Decrease) in Cash and Cash Equivalents 25,571,596 (1,270,136)Cash and Cash Equivalents and Restricted Cash - Beginning of Period 16,525,187 17,795,323 Cash -and Cash Equivalents and Restricted Cash - End of Period$42,096,783 $16,525,187