The STRATIFY II trial investigates the efficacy of three different approaches to reducing thrombus burdon in patients with acute intermediate high-risk pulmonary embolism: percutaneous embolectomy (the Flow Triever® system, INARI medical), USAT (EKOS® system, Boston Scientific with low dose alteplase) and heparin with the option to perform full-dose thrombolysis. As a co-primary secondary end point the trial assess the incremental efficacy of the embolectomy vs the catheter based low dose thrombolysis approach.
Thus the two main hypothesis being tested are:
1. Thrombus burden reduction after 48-96 h is increased with a catheter based (embolectomy or USAT) compared to the a heparin with optional high dose thrombolysis approach (1st co-primary outcome)
2. Thrombus burden reduction after 48-96 h is increased with percutaneous embolectomy compared to USAT with low-dose alteplase (2nd co-primary outcome)

Start Date01 Jun 2025

Sponsor / Collaborator

Rigshospitalet

[+2]

ChiCTR2400083577

/ SuspendedNot ApplicableIIT

A clinical study of low molecular weight heparin in improving pregnancy outcomes in women with repeated implant failure in freeze-thaw embryo transfer cycles

Start Date01 May 2025

Sponsor / Collaborator

The Second Hospital of Shandong University

NCT06845423

/ Not yet recruitingPhase 4IIT

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk. An Open-label, Randomized, Controlled Trial Comparing Two Strategies With or Without Pharmacological Thromboprophylaxis

Venous thromboembolism (VTE) is currently the second cause of death in women of reproductive age worldwide. The incidence of VTE during pregnancy is 1.2 to 1.4/1000 women, half of VTE occurring during postpartum and as PE in majority of cases, accounting for 8.8% of maternal deaths.
Majority of postpartum VTE occurs in women with one or more moderate risk factors (obesity, caesarean section, postpartum hemorrhage). For these women at intermediate risk, the efficacy and safety of thromboprophylaxis have not been assessed yet during postpartum and international guidelines for pharmacological thromboprophylaxis, based on data extrapolated from other populations, observational studies and small clinical trials are inconsistent across countries.
We designed an open-label, randomized, controlled trial, aiming to demonstrate the superiority of a pharmacological thromboprophylaxis strategy with LMWH (LMWH type chosen according to physician / patient's preference) during 6 weeks after delivery (the 6-weeks follow-up visit being matched with usual care) in women at intermediate risk, over no pharmacological thromboprophylaxis.

Start Date01 Apr 2025

Sponsor / Collaborator

University Hospital of Brest

100 Clinical Results associated with Heparin Calcium

100 Translational Medicine associated with Heparin Calcium

100 Patents (Medical) associated with Heparin Calcium

56,681

Literatures (Medical) associated with Heparin Calcium

31 Dec 2025·ANNALS OF MEDICINE

Low-dose heparin sodium as a protective factor against bronchiolitis obliterans formation after adenovirus infection

Article

Author: Hu, Rong ; Cui, Lei ; Ding, Xiaofang ; Peng, Li ; Zhong, Lili ; Lin, Lin ; Huang, Han ; Liu, Silan ; Chen, Min

BACKGROUND:

Adenovirus (ADV) pneumonia in children is a significant contributor to the occurrence of post-infectious bronchiolitis obliterans (BO). Heparin sodium has known anti-inflammatory, immunomodulatory, and tissue repair properties. However, its role in treating BO after ADV infection remains unclear.

METHODS:

A retrospective analysis was conducted on 793 children diagnosed with ADV pneumonia and hospitalized in the southern region from January 2019 to December 2019. Among them, 307 cases were classified as single ADV pneumonia. We utilized directed acyclic graphs to analyze the causal relationships between various variables, which further helped us identify the independent and confounding variables for constructing our regression model. Propensity score matching (PSM) was also employed to control for confounding variables that could not be intervened in this study, ensuring baseline level equilibrium and correction. We utilized univariate logistic regression analysis to explore the factors influencing BO development after ADV pneumonia.

RESULTS:

Among the 793 children diagnosed with ADV pneumonia, 86 cases (10.84%) progressed to BO. The proportion of heparin use was higher in the non-BO group than in the BO group after PSM. The univariate regression analysis revealed that acute respiratory failure, neurological involvement and fibrinogen (FIB) were risk factors for the development of BO in ADV pneumonia cases (OR > 1, p < 0.05), but low-dose heparin sodium treatment and hemoglobin (OR < 1, p < 0.05) exhibited protective effects against BO formation. Among the 307 children with single ADV pneumonia (excluding confounding factors), 33 cases (10.75%) developed BO. The univariate regression analysis further indicated that fever duration, acute respiratory failure and FIB were risk factors for the development of BO in single ADV pneumonia (OR > 1, p < 0.05), while low-dose heparin sodium treatment (OR < 1, p < 0.05) was protective against BO formation after a single ADV pneumonia.

CONCLUSION:

Low-dose heparin sodium treatment may be a protective factor against the development of BO after ADV pneumonia infection.

01 Oct 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Fibrinogen protected gold nanoclusters as an effective anticoagulant

Article

Author: Sun, Wenyu ; Liu, Liu ; Quan, Jinfeng ; Wang, Xuemei ; Jiang, Hui

Thrombin (TB) induces the conversion of soluble fibrinogen (FIB) to insoluble fibrin, which represents a crucial step in thrombus formation. Traditional anticoagulants primarily prevent thrombus formation by inhibiting TB activity. The clinical used anticoagulant, heparin indirectly inhibits TB activity, but suffers from its potential side effects that receive significant concerns. Herein, we present the potential application of fibrinogen template-based gold nanoclusters (FIB-AuNCs) for anticoagulation. FIB-AuNCs effectively maintain the binding site between FIB and TB, leading to direct and efficient inhibition of TB activity, while the larger FIB-Au nanoparticles show limited effect. Both in vitro and in vivo studies have demonstrated the high efficacy and safety of FIB-AuNCs compared with heparin, suggesting that the ultra-small size of FIB-AuNCs not only enhances anticoagulant efficacy but also significantly reduces potential toxicity to the liver and kidney. Therefore, we anticipate that FIB-AuNCs may emerge as a potential clinical anticoagulant candidate, which eventually promote the development of new anticoagulation therapeutic agents.

01 Oct 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Highly sensitive and selective AIE-based fluorometric sensor to detect heparin via the fluorescent Ni nanoclusters

Article

Author: Dissanayake, Manusha ; Sharma, Nallin ; Kumarihamy, Maheshika ; Wu, Hui-Fen

Metal nanoclusters play a significant role in emerging nano biosensing. We reported highly fluorescent Ni Nanoclusters and their possible application in heparin detection. Heparin can be identified as an important anticoagulant which also serves as a biomarker for a few diseases, including sepsis and diseases related to the immune system. The fluorescent nickel nanoclusters was synthesized with thiolate ligand surface capping by using the probe ultrasonication method. Here, thiourea was used as the capping agent and NaOH was applied as the reducing agent. The as-synthesized nickel nanoclusters have shown a significantly high greenish fluorescence with a decent quantum yield which stays stable over one month. The as-synthesized nanoclusters were functionalized with BSA protein for the selectivity towards heparin sensing and developed into an Aggregation Induced Emission (AIE)-based fluorescent sensor. In the sensing platform, the positively charged amino acid groups in BSA protein form electrostatic interactions with the negatively charged carboxyl groups and hydroxyl groups of Heparin to induce aggregation. The increase in fluorescence intensity had a wide linear range from 2.5-100 nM with an R² = of 0.98 and the reported LOD value was 9.448 nM in water and 19.02 nM in the serum sample. The quantum yield of the synthesized nanoclusters is 7.1 %. This highly sensitive and selective sensing platform with good stable fluorescence can be used as a potential AIE fluorescence sensor for the future biomedical field. This study reveals the possibilities of using the novel Ni NCs as a novel platform for sensors in the near future in various application fields.

251

News (Medical) associated with Heparin Calcium

14 May 2025

·ir.talphera.com

Talphera Announces First Quarter 2025 Financial Results and Provides Corporate Update

Cash and investments at March 31, 2025 , as adjusted to include the proceeds from the first tranche of the private placement financing which closed on April 2, 2025 , were $9.8 million Three new clinical study sites activated and screening patients thus far in 2025, with five additional sites expected by mid-year, for a total of 13 Conference call and webcast to be held Wednesday, May 14, 2025 at 4:30 pm ET SAN MATEO, Calif. , May 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced first quarter 2025 financial results and provided a corporate update. "We remain on track with new study site activation, including three institutions already activated and beginning to screen patients in 2025, and five new potentially high-enrolling sites by mid-year. The new target profile of our clinical study sites has proven beneficial as engagement with the principal investigators and activity at the sites is much higher than with the legacy sites with which we first initiated the study," stated Vince Angotti , CEO of Talphera. "We believe that the increased engagement from the new sites, including those expected to come on board in the coming months, will allow us to complete the 70-patient study by the end of the year. We expect our next enrollment update to occur when we enroll 17 patients, which is the milestone for closing the second tranche of our recent financing. Our confidence in the need for this product candidate continues to grow as we introduce more physicians to the Niyad clinical profile and NEPHRO study," continued Angotti. First Quarter 2025 and Recent Highlights In March 2025 , the Company announced it received approval from the U.S. Food and Drug Administration (FDA), on its Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study from 166 in the original study protocol to 70. With 70 patients, the primary endpoint is powered at 90%. In January 2025 , the agency also agreed to two other changes to broaden the clinical study inclusion criteria which allow the Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours, as well as heparin-tolerant patients at certain institutions. In March 2025 , Talphera announced the agreement for a financing of up to $14.8 million , including two committed tranches upon achievement of 25% and 50% enrollment and Talphera's stock price trades at a price at or above $0.7325 for five consecutive days following the announcement of achieving the enrollment milestones. The financing was led by existing investors, Nantahala Capital and Rosalind Advisors , and includes a member of management. The first tranche of this financing amounting to $4.4 million in net proceeds closed on April 2, 2025 . First Quarter 2025 Financial Information The cash and cash equivalents balance was $5.4 million as of March 31, 2025 . Combined R&D and SG&A expenses for the first quarter of 2025 totaled $2.9 million compared to $4.2 million for the first quarter of 2024. Excluding non-cash stock-based compensation expense, these amounts were $2.7 million for the first quarter of 2025, compared to $3.9 million for the first quarter of 2024. The decrease in combined R&D and SG&A expenses in the first quarter of 2025 was primarily due to reductions in personnel expense and other general and administrative expenses. For the first quarter of 2025, the Company recognized net loss from continuing operations of $2.7 million , as compared to net loss of $4.0 million for the first quarter of 2024, largely due to reductions in personnel expense in 2025 and the change in fair value of the Company's warrant liability, partially offset by the gain on sale of future payments in 2024. The divestment of DSUVIA represents a discontinued operation; accordingly, all historical operating results for the business are reflected within discontinued operations. Net income from discontinued operations was $0.1 million in the first quarter of 2025. Net loss attributable to common shareholders for the first quarter of 2025 was $2.6 million , or $0.10 per basic and diluted share, compared to a net loss of $4.0 million , or $0.16 per basic and diluted share, for the first quarter of 2024. 2025 Expense Guidance Cash operating expenses, or selling, general and administrative, and research and development expenses, excluding stock-based compensation, is expected to be in the range of $17 million to $19 million in 2025, which includes the expenses related to executing and completing the NEPHRO CRRT registration trial before the end of the year. Conference Call and Webcast Information Talphera will hold a conference call and webcast at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the results and provide an update on the Company's business. Investors who wish to participate in the conference call may do so by dialing 1-800-836-8184 for North American callers, or 1-646-357-8785 (toll applies) for international callers outside of Canada . The conference ID is 58894.The webcast can be accessed here or by visiting the Investors section of the Company's website at www.talphera.com and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation and a replay will be available on the Talphera website for 90 days following the event. About Talphera, Inc. Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA). This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com. About Niyad and Nafamostat Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad® is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad® is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or as an anti-viral treatment, amongst other potential targets. About the NEPHRO CRRT Study The NEPHRO CRRT Study, which has received central IRB approval, is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours. Forward-looking statements This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: Talphera's expectation that there will be five new potentially high-enrolling sites activated by mid-year, that the NEPHRO study enrollment rates will increase, and additional study sites will be activated allowing the study to be completed by the end of 2025; the potential of nafamostat to address unmet needs in anticoagulation of the extracorporeal circuit, and potential FDA approval of the nafamostat product candidate; Talphera's expectation that the committed capital from the private placement financing, upon completion of certain milestones and meeting certain closing conditions, should provide sufficient capital to fund the completion of the NEPHRO study, expected by the end of 2025; Talphera's expected cash operating expenses will be in the $17 million to $19 million range for 2025; and Talphera's ability to successfully meet the enrollment goals and minimum stock price to satisfy the requirements of the two additional committed private placement financing tranches. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC . Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. Selected Financial Data (in thousands, except per share data) (unaudited) Three Months Ended March 31 2025 2024 Statement of Operations Data Revenue $ 27 $ - Operating costs and expenses: Research and development (1) 1,169 1,433 Selling, general and administrative (1) 1,774 2,804 Total operating costs and expenses 2,943 4,237 Loss from operations (2,916) (4,237) Other income, net: Interest income and other income, net 69 220 Gain on sale of future payments - 1,246 Gain (loss) on change in fair value of warrant liability 181 (1,002) Non-cash interest expense on liability related to sale of future payments - (181) Total other income, net 250 283 Net loss from continuing operations (2,666) (3,954) Net income from discontinued operations 73 - Net loss $ (2,593) $ (3,954) Net loss per share attributable to stockholders: Basic and diluted, continuing operations $ (0.10) $ (0.16) Basic and diluted, discontinued operations $ 0.00 $ - Basic and diluted loss per share $ (0.10) $ (0.16) Shares used in computing net loss per share of common stock, basic and diluted 26,268 24,722 (1) Includes the following non-cash stock-based compensation expense: Research and development $ 77 $ 107 Selling, general and administrative 119 195 Total $ 196 $ 302 Selected Balance Sheet Data (in thousands) March 31, 2025 December 31, 2024 (1) (Unaudited) (Unaudited) Cash, cash equivalents and investments $ 5,388 $ 8,863 Total assets 14,995 18,236 Total liabilities 9,396 10,235 Total stockholders' equity 5,599 8,001 (1) Derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 . Reconciliation of Non-GAAP Financial Measures (Operating Expenses less stock-based compensation expense) Three Months Ended March 31 (unaudited) 2025 2024 Operating expenses (GAAP): Research and development $ 1,169 $ 1,433 Selling, general and administrative 1,774 2,804 Total operating expenses 2,943 4,237 Less stock-based compensation expense 196 302 Operating expenses (non-GAAP) $ 2,747 $ 3,935 View original content to download multimedia:https://www.prnewswire.com/news-releases/talphera-announces-first-quarter-2025-financial-results-and-provides-corporate-update-302455637.html SOURCE Talphera, Inc. Investor Contacts: Talphera, Raffi Asadorian, CFO, 650-216-3500, investors@talphera.com; LifeSci Advisors, Kevin Gardner, 617-283-2856, kgardner@lifesciadvisors.com

Financial StatementPhase 3Breakthrough Therapy

06 May 2025

·www.globenewswire.com

CorMedix Inc. Reports First Quarter 2025 Financial Results and Provides Business Update

‒ Q1 2025 Net Revenue of $39.1mm; Adjusted EBITDA of $23.6mm ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time BERKELEY HEIGHTS, NJ., May 06, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2025 and provided an update on its business. Recent Corporate Highlights: CorMedix announces net sales of $39.1 million for the first quarter of 2025, largely driven by successful implementation by its outpatient dialysis customers. The Company’s first quarter of 2025 was profitable and cash flow positive, with net income of $20.6 million, adjusted EBITDA of $23.6 million, and cash from operations of $19.7 million.The Company’s dedicated inpatient sales team is now fully staffed, trained, and operational in the field. DefenCath inpatient institutional shipments have doubled over the past three months and the Company anticipates continued inpatient growth throughout 2025.CorMedix commenced its Phase 3 study for the reduction of Central Line Associated Blood Stream Infections (CLABSIs) in adult patients receiving Total Parenteral Nutrition (TPN) through a central venous catheter. The first site is operational and actively screening patients.CorMedix expects to be at the high-end of the previously announced first half net sales guidance of $62 million to $70 million, based on latest order trends and inventory tracking with current purchasing customers.Cash and short-term investments, excluding restricted cash, at March 31, 2025 amounted to $77.5 million. First Quarter 2025 Financial Highlights For the first quarter of 2025, CorMedix recorded $39.1 million in net revenue from sales of DefenCath, and recorded net income of $20.6 million, or $0.32 per share, compared with a net loss of $14.5 million, or $0.25 per share, in the first quarter of 2024. The net income was driven primarily by net sales of DefenCath in the period. Operating expenses in the first quarter of 2025 were $17.4 million, compared with $15.9 million in the first quarter of 2024, an increase of approximately 9%. The increase was driven by higher research and development (R&D) expenses of $3.2 million, compared with $0.8 million for the same period in 2024. The increase in R&D was primarily due to the increase in personnel and clinical trial services in support of the ongoing clinical programs. General and administrative expenses increased approximately 11% to $9.7 million in first quarter of 2025, driven primarily by non-cash charges for stock-based compensation. Selling and marketing expense decreased approximately 29% to $4.5 million in first quarter of 2025. This decrease is considered temporary due to the timing of onboarding the outsourced sales force during first quarter. The Company expects these costs to be normalized for the second quarter of 2025 and to be more closely in-line with the comparison period. The Company reported cash and short-term investments of $77.5 million at March 31, 2025, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q. Conference Call Information The management team of CorMedix will host a conference call and webcast today, May 6, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: Tuesday, May 6th @ 8:30am ETDomestic: 1-844-676-2922International: 1-412-634-6840Conference ID: 10198548Webcast: Webcast Link About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas. 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, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. 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. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, 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 such forward-looking statements speak only as of the date of this press release. 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. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSAND COMPREHENSIVE LOSS(Unaudited) For the Three Months Ended March 31, 2025 2024 Revenue Net sales$39,081,657 $- Cost of revenues (1,596,715) (818,539)Gross income (loss) 37,484,942 (818,539)Operating Expenses Research and development (3,192,440) (837,445)Selling and marketing (4,473,840) (6,337,219)General and administrative (9,693,382) (8,711,033)Total operating expenses (17,359,662) (15,885,697)Income (Loss) from Operations 20,125,280 (16,704,236)Other Income (Expense) Total other income 518,618 843,343 Net Income (Loss) Before Income Taxes 20,643,898 (15,860,893)Tax benefit - 1,394,770 Net Income (Loss) 20,643,898 (14,466,123)Other Comprehensive Income (Loss) Total other comprehensive loss (6,090) (10,647)Other Comprehensive Income (Loss) $20,637,808 $(14,476,770)Net Income (Loss) Per Common Share – Basic$0.32 $(0.25)Net Income (Loss) Per Common Share – Diluted $0.30 $(0.25) Weighted Average Common Shares Outstanding – Basic65,244,341 57,503,154 Weighted Average Common Shares Outstanding – Diluted 68,975,418 57,503,154 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEET DATA March 31, December 31, 2025 2024 (Unaudited) (Audited) ASSETS Cash, cash equivalents and restricted cash$66,390,985 $40,756,138 Short-term investments$11,216,989 $11,036,857 Total Assets $149,582,766 $118,845,673 Total Liabilities $34,694,718 $34,188,723 Accumulated deficit$(318,986,135)$(339,630,033) Total Stockholders’ Equity $114,888,048 $84,656,950 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited) For the Three Months Ended March 31, 2025 2024 Cash Flows from Operating Activities: Net income (loss)$20,643,898 $(14,466,123)Net cash provided by (used in) operating activities 19,736,503 (17,310,294)Cash Flows Used in Investing Activities: Net cash (used in) provided by investing activities (194,820) 8,944,932 Cash Flows from Financing Activities: Net cash provided by (used in) financing activities 6,092,935 (97,118)Net Increase (Decrease) in Cash and Cash Equivalents 25,634,847 (8,463,285)Cash and Cash Equivalents and Restricted Cash - Beginning of Period 40,756,138 43,823,192 Cash and Cash Equivalents and Restricted Cash - End of Period$66,390,985 $35,359,907 CORMEDIX INC. AND SUBSIDIARIESNon-GAAP Reconciliations(Unaudited) Three Months Ended March 31, 2025 Net income (loss) $20,643,898 Adjusted to add (deduct): Interest expense (income), net (556,790) Provision for (benefit from) income taxes - Depreciation and amortization 161,942 EBITDA (Non-GAAP) $20,249,050 Adjusted to add (deduct): Stock-based compensation expense 3,500,355 Restructuring expense (145,976) Adjusted EBITDA (Non-GAAP) $23,603,429

Financial StatementPhase 3Drug Approval

06 May 2025

·cormedix.com

CORMEDIX INC. REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

‒ Q1 2025 Net Revenue of $39.1mm; Adjusted EBITDA of $23.6mm ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time Berkeley Heights, NJ – May 6, 2025 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2025 and provided an update on its business. Recent Corporate Highlights: CorMedix announces net sales of $39.1 million for the first quarter of 2025, largely driven by successful implementation by its outpatient dialysis customers. The Company’s first quarter of 2025 was profitable and cash flow positive, with net income of $20.6 million, adjusted EBITDA of $23.6 million, and cash from operations of $19.7 million. The Company’s dedicated inpatient sales team is now fully staffed, trained, and operational in the field. DefenCath inpatient institutional shipments have doubled over the past three months and the Company anticipates continued inpatient growth throughout 2025. CorMedix commenced its Phase 3 study for the reduction of Central Line Associated Blood Stream Infections (CLABSIs) in adult patients receiving Total Parenteral Nutrition (TPN) through a central venous catheter. The first site is operational and actively screening patients. CorMedix expects to be at the high-end of the previously announced first half net sales guidance of $62 million to $70 million, based on latest order trends and inventory tracking with current purchasing customers. Cash and short-term investments, excluding restricted cash, at March 31, 2025 amounted to $77.5 million. First Quarter 2025 Financial Highlights For the first quarter of 2025, CorMedix recorded $39.1 million in net revenue from sales of DefenCath, and recorded net income of $20.6 million, or $0.32 per share, compared with a net loss of $14.5 million, or $0.25 per share, in the first quarter of 2024. The net income was driven primarily by net sales of DefenCath in the period. Operating expenses in the first quarter of 2025 were $17.4 million, compared with $15.9 million in the first quarter of 2024, an increase of approximately 9%. The increase was driven by higher research and development (R&D) expenses of $3.2 million, compared with $0.8 million for the same period in 2024. The increase in R&D was primarily due to the increase in personnel and clinical trial services in support of the ongoing clinical programs. General and administrative expenses increased approximately 11% to $9.7 million in first quarter of 2025, driven primarily by non-cash charges for stock-based compensation. Selling and marketing expense decreased approximately 29% to $4.5 million in first quarter of 2025. This decrease is considered temporary due to the timing of onboarding the outsourced sales force during first quarter. The Company expects these costs to be normalized for the second quarter of 2025 and to be more closely in-line with the comparison period. The Company reported cash and short-term investments of $77.5 million at March 31, 2025, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q. Conference Call Information The management team of CorMedix will host a conference call and webcast today, May 6, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: Tuesday, May 6th @ 8:30am ET Domestic: 1-844-676-2922 International: 1-412-634-6840 Conference ID: 10198548 Webcast: Webcast Link About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 and also intends to develop DefenCath as a catheter lock solution for use in other therapeutic areas. 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, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. 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. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, 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 such forward-looking statements speak only as of the date of this press release. 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. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Financial StatementPhase 3Drug Approval

100 Deals associated with Heparin Calcium

External Link

KEGG	Wiki	ATC	Drug Bank
D04427	Heparin Calcium	S01XA14 B01AB01 C05BA03	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Blood Coagulation Disorders	China	Sanofi Synthelabo HK Ltd.	07 Dec 2000
Venous Thromboembolism	China	Sanofi Synthelabo HK Ltd.	07 Dec 2000

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Phase 2	United Kingdom	Ockham Biotech Ltd.	30 Jan 2022
Cystic Fibrosis	Phase 1	United Kingdom	Ockham Biotech Ltd.	30 Jan 2022
Diabetes Mellitus, Type 1	Phase 1	Germany	Sanofi	17 Feb 2017
Asthma	Preclinical	United Kingdom	Ockham Biotech Ltd.	30 Jan 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2024	Not Applicable	Glucose Metabolism Disorders	-	Heparin premedication	plfhoyxfdq(dpcqpwwfea) = mrvaxnldjf tnkvfbthrv (rhrevilhha )	-	30 Aug 2024
				No heparin premedication	plfhoyxfdq(dpcqpwwfea) = oqheamipkm tnkvfbthrv (rhrevilhha )
ATS2024	Not Applicable	Hematoma	-	Heparin infusion	crcrtwpgsy(wkhzfbqtxs) = SPH in a patient on heparin was first described in 1996, almost 80 years after heparin was first used. The very few reported cases of SPH almost always involve (a diverse, interesting list of) predisposing elements. Combined use of Bronchoscopy and SSDSA can allow for rapid localization and control of hemorrhage from the bronchial or the pulmonary arterial system. Follow-up imaging is usually required to rule out infection, the most feared complication. ycykwxnqpo (dihpeumigd )	-	19 May 2024
AAN2024	Not Applicable	Heparin-induced thrombocytopenia and thrombosis	-	Heparin (Ocular Ischemic Syndrome (OIS))	siqhqhokqy(rkmhorxkar) = OIS is a rare complication of HITT, occurring within two weeks of repeat exposure to heparin following initial exposure within three months. Awareness of both conditions is crucial to guide prompt management and optimal care to prevent neurologic sequelae. bjdumeltcx (ugwnwxywtd )	-	09 Apr 2024
ESC2024	Not Applicable	Shock, Cardiogenic	-	heparin (Normal fibrinogen levels and normal INR)	jntspjzyqw(sqizrgfpos) = akxwadtwqz zatyieenmd (xmoehjsihs )	-	09 Mar 2024
				heparin (Reduced fibrinogen levels and/or prolonged INR)	jntspjzyqw(sqizrgfpos) = kcfysxoedx zatyieenmd (xmoehjsihs )
PERIOP-01 (ASH2023)	Not Applicable	Colorectal Cancer	614	Extended duration thromboprophylaxis with low-molecular-weight-heparin	ccdjcggnen(joozjiorwf) = ckqudpbzbt ezzwrkyflz (ruibczyakp ) View more	-	10 Dec 2023
				Standard duration thromboprophylaxis	ccdjcggnen(joozjiorwf) = frsspeihub ezzwrkyflz (ruibczyakp ) View more
ESC2023	Not Applicable	-	768	Heparin dose 50IU/kg	vfgadvbxvs(ojjzsswygf) = wyqmhzvgfp qrlqozbdjm (vjkyswsosq )	-	27 Aug 2023
				Heparin dose ≥70IU/kg	vfgadvbxvs(ojjzsswygf) = dtjubwbhtb qrlqozbdjm (vjkyswsosq )
ATS2023	Not Applicable	Thrombosis	-	Heparin	txflvtxdxv(fecqtxfokw) = Frequently described complications of HIT thrombosis (HITT) include arterial thromboembolism including acute limb ischemia, myocardial infarction and venous thromboembolism. Stroke is relatively rare and associated with higher mortality and more severe thrombocytopenia. Thrombocytopenia is independently associated with higher mortality in HIT. qrougzwrqv (daaoamhsbe ) View more	-	21 May 2023
				Argatroban
NCT03894904 (CTgov)	Phase 4	Anesthesia \| Vasospasm	100	Heparin+papaverine (Papaverine Plus Heparin During Procedure, With Rescue Papaverine as Needed)	dtfpaaybes = bqfqrslrqg lkynqjfvpd (drslvsmrkc, otfqzkghfg - unxdqwrruy) View more	-	27 Oct 2022
				Heparin+papaverine (Heparin During Procedure, With Rescue Papaverine as Needed)	dtfpaaybes = vikepifhts lkynqjfvpd (drslvsmrkc, kekenhwixt - vbdezsjede) View more
ISTH2022	Not Applicable	COVID-19	-	Standard-dose heparin prophylaxis	ysmgvrycto(sbfgnsiion) = budbeallje lkoglmbvpc (pdlgvwxjgt ) View more	-	09 Jul 2022
				High-dose heparin prophylaxis	ysmgvrycto(sbfgnsiion) = zvlbmtkpje lkoglmbvpc (pdlgvwxjgt ) View more
Highlow Study (ISTH2022)	Not Applicable	Venous Thromboembolism D-dimer \| PAP \| von Willebrand factor (vWF) ... View more	217	Intermediate-dose low-molecular-weight heparin	srhxuaminy(midsfohreq) = xyoeidvhze xoxjeyytbc (cuopvxmqxf )	-	09 Jul 2022
				Low-dose low-molecular-weight heparin	srhxuaminy(midsfohreq) = qiaqkmirvs xoxjeyytbc (cuopvxmqxf )

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Heparin Calcium

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