A Master Protocol for a Phase 1b Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 and REGN7508, Factor XI Monoclonal Antibodies, and REGN9533, a Factor XII Monoclonal Antibody, in Participants With End-Stage Kidney Disease on Hemodialysis

This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533.
The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard anticoagulant treatment, such as heparin, to reduce the risk of blood clots as they can lead to serious health problems or be life-threatening. Because participants with ESKD who have hemodialysis have a higher risk of bleeding, the IMPs could be a meaningful new therapeutic option.
The main aim of the study is to see what side effects may happen from taking REGN9933, REGN7508, or REGN9533.
The study is looking at several other research questions, including:
* How much IMP is in the blood at different times and
* If the IMPs affect the ability of the blood to clot normally

Start Date09 Sep 2026

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

JPRN-jRCT1012260032

/ Not yet recruitingNot Applicable

A single-center, prospective, open-label, parallel-group pilot randomized controlled trial of granulocyte and monocyte adsorption therapy with Adacolumn in ICU patients with sepsis (Adacolumn Pilot RCT)

Start Date17 Jul 2026

Sponsor / Collaborator-

NCT06381661

/ RecruitingPhase 2IIT

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

Start Date09 Jul 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

100 Clinical Results associated with Heparin Calcium

100 Translational Medicine associated with Heparin Calcium

100 Patents (Medical) associated with Heparin Calcium

48,561

Literatures (Medical) associated with Heparin Calcium

31 Dec 2026·RENAL FAILURE

Implementation quality as a modifiable determinant of filter lifespan in regional citrate anticoagulation: a real-world clustering-adjusted study

Article

Author: He, Dan ; Liang, Zhili ; Yan, Wenjuan ; Wang, Hongjuan ; Ou, Qing ; Liu, Yanan ; Li, Yucheng ; Zeng, Zhenhua ; Wei, Hongyun ; Hu, Hongbin

Continuous renal replacement therapy (CRRT) is widely used in critically ill patients, but filter clotting remains a common complication. Regional citrate anticoagulation (RCA) is recommended; however, its real-world effectiveness may depend on implementation quality. This single-center retrospective cohort study analyzed 420 CRRT sessions from 1 September 2025 to 30 November 2025. Mixed-effects Cox models with patient-level random intercepts and competing-risk analysis were used. The primary outcome was filter clotting. In adjusted analyses, RCA was associated with a significantly reduced hazard of filter clotting compared with heparin (adjusted hazard ratio (aHR) for heparin vs. RCA: 1.78, 95% confidence interval (CI): 1.14-2.77, p = 0.011). Nafamostat showed no statistically significant difference from RCA (aHR: 1.31, 95% CI: 0.78-2.19, p = 0.31); however, the wide CI reflects limited sample size, and equivalence cannot be inferred. Within the RCA group, absence of timely post-filter ionized calcium (iCa²⁺) monitoring within 2 h was independently associated with increased clotting risk (adjusted odds ratio: 2.18, 95% CI: 1.24-3.84, p = 0.007), with a dose-response relationship (each one-hour delay increased clotting odds by 15%, p = 0.02). Major bleeding was infrequent (2.1% overall); metabolic complications (citrate accumulation) occurred in 2.9% of RCA sessions. In this cluster-adjusted real-world cohort, RCA was associated with improved filter survival compared with heparin. Implementation fidelity, particularly timely post-filter iCa²⁺ monitoring, appears to influence RCA effectiveness.

31 Dec 2026·RENAL FAILURE

Risk factors for hypotension and technical complications during single-session double-filtration plasmapheresis: a 15-year retrospective study of 1,022 procedures

Article

Author: Jing, Meng ; Ma, Jun ; Gao, Chenni ; Chen, Xiaonong ; Zhu, Yujia ; Chen, Zijin ; Yu, Haijin ; Yang, Zhenhua ; Xie, Jingyuan

Double-filtration plasmapheresis (DFPP) is increasingly used for immune-mediated and hematologic diseases, yet real-world safety data remain limited. In this 15-year retrospective study, we analyzed 1,022 DFPP sessions performed in 385 patients. The primary outcomes were hypotension and technical complications. Patient demographics, indications, laboratory parameters, treatment prescriptions, anticoagulation regimens, and procedure-related adverse events were collected. Mixed-effects logistic regression models were applied to identify factors associated with hypotension and technical complications. Hyperviscosity syndrome was the most common indication, accounting for 55.3% of all sessions. The mean treatment volume was 3.06 ± 0.41 L, corresponding to 0.95 ± 0.16 times the estimated plasma volume. Hypotension occurred in 15.3% of sessions and technical complications in 7.6%, both demonstrating significant declining trends over time (p < 0.05 for trend). Immune thrombotic thrombocytopenic purpura was independently associated with hypotension (OR 11.96, 95% CI 1.94-73.68). Older age modestly increased risk (OR 1.03 per year, 95% CI 1.00-1.06), while treatment year was inversely associated with hypotension (OR 0.77 per year, 95% CI 0.66-0.89). Technical complications were independently associated with use of the PLASAUTO Σ system (OR 8.78, 95% CI 2.76-27.97), use of non-heparin/non-nafamostat anticoagulants (OR 9.42, 95% CI 2.71-32.72), and hyperviscosity syndrome (OR 8.09, 95% CI 1.80-36.29). Among 309 sessions with paired measurements, median immunoglobulin reduction was 29.8% for IgG overall. DFPP demonstrated an acceptable safety profile, with declining complication rates over time. The risk of complications was influenced by underlying disease, patients' status, and anticoagulation strategy.

31 Dec 2026·RENAL FAILURE

Comparative efficacy of low-concentration trisodium citrate and low-concentration heparin for locking central venous hemodialysis catheters: a randomized controlled study

Article

Author: Wongwatanasanti, Kwansuphang ; Pattharanitima, Pattharawin ; Banchonglaksa, Wanna ; Tantiyavarong, Pichaya ; Chatkrailert, Aphichat ; Anumas, Suthiya

Central venous catheters (CVCs) are used in hemodialysis patients when arteriovenous fistulas (AVFs) or grafts (AVGs) are not feasible. Catheter-locking anticoagulants (CLAs), such as low-concentration trisodium citrate (TSC) and unfractionated heparin (UFH), are used to prevent catheter dysfunction (CD), but comparative data on their safety and efficacy - especially at low concentration remain limited. This study evaluates the efficacy of low-concentration TSC versus low-concentration UFH as CLAs in hemodialysis CVCs. Patients undergoing hemodialysis were randomly allocated to receiving either 5% TSC or UFH 1000 U/mL as CLAs. The primary outcome was the CD rate. Secondary outcomes encompass catheter-related bloodstream infection (CRBSI), exit site infection (ESI), bleeding events, and mortality at 180 days. A total of 204 hemodialysis patients were randomized to receive either 5% trisodium citrate or 1,000 U/mL unfractionated heparin as catheter-locking anticoagulants. The CD rates at 180 days were 1.11 and 1.73 per 1,000 catheters-days for TSC and UFH, respectively, yielding an incidence rate ratio of 1.55 (95% CI: 0.72-3.45), p = 0.23. CRBSI and ESI were comparable in both groups. Bleeding and mortality were also not significantly different between the groups. In the sensitivity analysis of tunnel cuffed catheters (TCC), the rate of CD remained not significantly different between the groups; however, the rate of ESI was higher in the UFH group. Both 5% TSC and 1,000 U/mL UFH demonstrated comparable overall efficacy and safety as CLAs. A possible reduction in infectious complications with 5% TSC was observed only in the tunneled cuffed catheter subgroup.

340

News (Medical) associated with Heparin Calcium

31 Aug 2026

·www.biospace.com

Cadrenal Therapeutics Announces Positive Outcome from FDA Type D Meeting for Phase 3 Registration Study of CAD-1005 in Heparin-Induced Thrombocytopenia

FDA Alignment on Primary Endpoint and Path Forward for Phase 3 Registration Study CAD-1005 Targets a Significant Unmet Need, with Approximately 50,000 Confirmed Acute HIT Diagnoses Annually in the U.S. and an Estimated $2 Billion in Peak Annual Revenue Opportunity PONTE VEDRA, Fla., Aug. 31, 2026 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, today announced positive feedback from a Type D Meeting with the U.S. Food and Drug Administration (FDA) held on July 28, 2026. During the meeting, Cadrenal and the FDA aligned on key aspects of the protocol and Statistical Analysis Plan (SAP) for the Phase 3 registrational study of CAD-1005, the Company’s first-in-class 12-lipoxygenase (12-LOX) inhibitor in development to treat heparin-induced thrombocytopenia (HIT). HIT is a potentially life-threatening immune reaction to heparin, a widely used blood thinner, and can lead to dangerous blood clots. In the U.S., heparin-induced thrombocytopenia (HIT) is a high-stakes emergency that affects approximately 50,000 patients with acute HIT each year. Current therapeutic options rely on standard anticoagulants to reduce thrombotic risk; however, they do not target the underlying immune mechanisms that drive this destructive cardiovascular cascade. CAD-1005 is a novel 12-LOX inhibitor designed to halt the core immune signaling pathway that drives platelet activation and vascular thrombosis. Developed as an essential add-on to standard anticoagulation, CAD-1005 targets a critical population and is projected to generate $2 billion in peak annual revenue. During the Type D meeting, the FDA agreed on an optimized definition of worsening HIT for the primary endpoint, based on progression of thrombotic events through Day 14 of treatment or hospital discharge. To ensure high-quality, reliable endpoint evaluation across clinical sites, the worsening component of the primary endpoint will also include extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements. The updated composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge. Additionally, the FDA agreed to use placebo control in the Phase 3 trial, with standard anticoagulation therapeutics for both the CAD-1005 and placebo control arms. "We are very pleased with the collaborative, constructive feedback from the FDA during this Type D meeting," said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. "Securing agreement on the primary endpoint definition and the blinding protocols for our saline control provides greater clarity on the regulatory path forward for CAD-1005. We have incorporated the Agency's recommendations into our Phase 3 protocol and Statistical Analysis Plan, strengthening the design of a registration study intended to evaluate whether CAD-1005 can reduce dangerous thrombotic events that persist in patients with HIT despite current anticoagulant therapies." The Phase 3 trial design will also assess bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria. All safety analyses will be conducted in the safety population of patients who receive at least one dose of the study drug. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. The Company’s pipeline includes CAD-1005, tecarfarin, and frunexian. CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has an Orphan Drug Designation (“ODD”) from the U.S. Food and Drug Administration (“FDA”) for prophylaxis of thrombosis in patients with HIT, FDA Fast Track designation for the treatment and prevention of HIT, and an orphan designation from the European Medicines Agency for the treatment of platelet-activating factor 4 disorders. Second-generation 12-LOX oral therapeutics (CAD-2000) are also in development for chronic indications. The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request to the FDA for Rare Pediatric Disease Designation (RPDD) for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA. For more information, visit and connect with the Company on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the planned Phase 3 registration study of CAD-1005, the development of CAD-1005 to treat HIT; CAD-1005 potentially halting the core immune signaling pathway that drives platelet activation and vascular thrombosis; CAD-1005 being an essential add-on to standard anticoagulation; CAD-1005 unlocking a projected $2 billion in peak annual revenue; the worsening component of the primary endpoint of optimized definition of worsening HIT assessing extension of an existing thrombus into a new vascular segment or bed, avoiding potential site-to-site variability from manual size measurements; the updated composite primary endpoint measuring the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events (CTEs) through Day 14 or hospital discharge; the regulatory path forward for CAD-1005; the registration study evaluating whether CAD-1005 can reduce dangerous thrombotic events that continue to occur in patients with HIT despite current anticoagulant therapies; the Phase 3 trial design evaluating bleeding as a major safety endpoint using standard International Society on Thrombosis and Haemostasis (ISTH) criteria; all safety analyses in the Phase 3 trial being conducted in the true safety population of patients who receive at least one dose of the study drug; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; CAD-1005 being successfully developed to treat HIT and CSA-AKI; CAD-1005 selectively inhibiting 12-LOX, an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT; CAD-1005 being intended to be used alongside existing standards of care and being developed to address the underlying biological mechanisms that drive disease progression; second-generation 12-LOX oral therapeutics (CAD-2000) being developed for chronic indications; tecarfarin, a late-stage oral vitamin K antagonist, potentially preventing heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease; and the FDA’s ultimate decision regarding the Company’s request for RPDD for tecarfarin for the prevention of life-threatening blood clots inside coronary artery aneurysms in children with Kawasaki Disease; Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to advance its programs to clinical trial readiness; the Company’s ability to enter into development, licensing, and commercialization transactions for CAD-1005, frunexian, and tecarfarin; the Company’s ability to secure nondilutive grants to advance its programs; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. For more information, please contact: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 CVKD@lythampartners.com

20 Aug 2026

·www.biospace.com

VarmX enrols first participant in global Phase 3 EquilibriX-S trial evaluating VMX C001 in urgent surgery

VarmX enrols first participant in global Phase 3 EquilibriX‑S trial evaluating VMX‑C001 in urgent surgery First participant enrolled:  EquilibriX‑S (NCT07288489), a landmark registrational Phase 3 study of VMX-C001 vs usual pharmacologic care in patients taking FXa inhibitors who require urgent surgery/procedures, has begun enrolment Global scope: Participants to be recruited across more than 20 countries; clinical efficacy and safety endpoints will support worldwide regulatory submissions Innovative therapy: VMX-C001 is a recombinant modified human coagulation Factor X protein developed to be insensitive to Factor Xa inhibitors, specifically designed for rapid fixed-dose IV administration and for minimizing additional thrombotic risk; both being assessed in ongoing clinical trials Leiden, The Netherlands, 20 August 2026 , VarmX, a biotech company developing innovative approaches to bypass direct oral anticoagulants targeting activated factor Xa (FXa inhibitors), enrolled the first participant in its global Phase 3 EquilibriX-S trial. The trial is evaluating VarmX’s lead asset, VMX‑C001, for the rapid restoration of normal coagulation in patients taking any FXa inhibitor who require an urgent surgery/procedure. EquilibriX‑S is a randomized, controlled Phase 3 study enrolling participants across more than 20 countries. The trial will examine whether a single intravenous dose of VMX‑C001 can reliably and quickly restore hemostasis during urgent surgical procedures in participants receiving FXa inhibitors within the previous 15 hours. The primary endpoint is the proportion of participants achieving good or excellent hemostatic efficacy, with safety endpoints also being evaluated. VMX-C001 is a recombinant modified human coagulation Factor X protein engineered to be insensitive to Factor Xa inhibitors, designed to bypass their anticoagulant activity and support restoration of the coagulation cascade. VMX-C001's potential advantages in addition to coagulation restoration include fixed-dose administration regardless of the specific FXa inhibitor used, rapid IV delivery, preservation of common anticoagulants, such as heparin, and a minimized thrombotic risk profile. These properties are being evaluated as part of the ongoing pivotal phase 3 clinical trial EquilibriX-S, with the aim of establishing VMX-C001 as a treatment option for patients on FXa inhibitors requiring emergency surgery. John Glasspool, Chief Executive Officer of VarmX, commented: “Enrolling the first participant in EquilibriX‑S marks a significant milestone for VarmX and for the millions of patients taking Factor Xa inhibitors who may one day need an urgent surgery or procedure. VMX‑C001 has shown the potential to restore coagulation regardless of which FXa inhibitor a patient is taking, and this Phase 3 trial will provide the pivotal data needed for regulatory approval. We are grateful to our dedicated team, investigators, clinical partners and our strategic collaborator, CSL, for their efforts in bringing this programme to patients.” By 2030, approximately 30 million patients in the U.S., Europe and Japan are expected to receive FXa inhibitors as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge*. * RBC and Cowen (2018–2024), Syneos Health Consulting (incl. Japan), and clinical literature ENDS Notes to Editors About VarmX VarmX was spun out from Leiden University Medical Center (LUMC), in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter. Most recently, VarmX signed a strategic collaboration with CSL to fund the EquilibriX-S trial. For more information, please visit For further information, please contact: Vigo Consulting (media enquiries) Rozi Morris/ Melanie Toyne Sewell +44 20 7390 0230 VarmX@vigoconsulting.com

Phase 3

13 Aug 2026

·www.biospace.com

Cormedix Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

‒ Q2 2026 Consolidated Revenue of $101.9 million ‒ ‒ Q2 2026 Net Income of $26.0 million ; Adjusted EBITDA of $58.7 million ‒ ‒ Company Maintains FY 2026 Revenue and Raises Adjusted EBITDA Guidance ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ PARSIPPANY, N.J., Aug. 13, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today announced financial results for the second quarter ended June 30, 2026, and provided an update on its business. Recent Corporate Highlights: CorMedix announces $101.9 million of total revenue and grant income (“consolidated revenue”) for the second quarter of 2026, reflecting strong second quarter execution and positive underlying demand trends. The Company also recognized net income of $26.0 million and adjusted EBITDA of $58.7 million (1). Basic and fully diluted EPS were $0.33 and $0.29 per share, respectively, for the quarter. DefenCath® (taurolidine and heparin) sales contributed $66.1 million of net revenue in the second quarter, driven by continued utilization of DefenCath by large outpatient dialysis customers. The acquired Melinta portfolio contributed $35.8 million. CorMedix announced today that in collaboration with our global development partner Mundipharma, the company anticipates FDA submission of the sNDA for an expanded indication of REZZAYO for the prophylaxis of invasive fungal disease in the third quarter of this year. Provided the application is accepted for FDA review, the Company anticipates agency action on the application in H1 2027. The Company signed a new multi-year commercial supply agreement for DefenCath® with a Large Dialysis Operator (LDO), expanding the company’s commercial contract footprint to include all of the top 5 providers of dialysis services in the U.S. market. The LDO has commenced ordering of DefenCath® and will begin a pilot in the third quarter this year. The Company maintains full-year 2026 consolidated revenue guidance of $325 to $345 million, and raises full-year adjusted EBITDA guidance to a range of $125 to $140 million. Cash OpEx guidance is narrowed to a range of $145 to $155 million. Cash and short-term investments, excluding restricted cash, at June 30, 2026 totaled $256.7 million. Joseph Todisco, CorMedix Chairman & CEO, commented, “CorMedix delivered a strong second quarter, generating $101.9 million in consolidated revenue and $58.7 million of adjusted EBITDA, reflecting continued execution across our business. We remain confident in our full-year 2026 outlook and our revenue and adjusted EBITDA guidance as we continue to navigate the post-TDAPA reimbursement environment for DefenCath with discipline and focus. We also made meaningful progress across our pipeline and expect the near-term submission of the REZZAYO sNDA for prophylaxis. With a strong balance sheet, meaningful cash position, and a disciplined capital allocation strategy, we believe CorMedix is well positioned to support our commercial priorities, advance high-value development programs, and create sustainable long-term value for shareholders." (1) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See “Non-GAAP Financial Measures” on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure. Second Quarter 2026 Financial Highlights For the second quarter of 2026, CorMedix recorded $101.9 million in consolidated revenue, comprised of $66.1 million in sales of DefenCath and $35.8 million associated with the acquired Melinta portfolio, an increase from $39.7 million in total revenue in the comparable period of 2025. DefenCath sales increased year over year largely due to the onboarding of a large dialysis organization in mid-2025. As the Melinta acquisition occurred in August 2025, the second quarter of 2025 included revenue from only sales of DefenCath. Total operating expenses in the second quarter of 2026 were $34.2 million, compared with $18.3 million in the second quarter of 2025, an increase of approximately 87%. The increase of $15.9 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter and reflects the larger combined company. Research and development (R&D) expenses in the second quarter of 2026 were $6.7 million, compared with $2.4 million for the same period in 2025. The increase in R&D was primarily due to an increase in personnel and clinical trial services in support of the ongoing clinical programs, including pediatric studies for several brands and the continued investment in the development of DefenCath for the TPN indication. Selling and marketing expense increased approximately 95% to $12.4 million in the second quarter of 2026 from $6.4 million in the second quarter of 2025. The increase was primarily due to higher personnel cost associated with the larger product portfolio and related marketing programs. General and administrative expenses increased approximately 59% to $15.1 million in the second quarter of 2026 from $9.5 million in the second quarter of 2025. The increase was primarily attributable to higher costs associated with operating as a combined company following the acquisition, including branded prescription drug fees, and higher personnel, information technology, legal and facilities costs. This year-over-year increase in G&A was partially offset by the recognition of $4.2 million during the three months ended June 30, 2026, of expected insurance reimbursement of legal fees incurred by the Company to support its ongoing securities litigation. Of the $4.2 million credit recorded in the second quarter, $2.7 million related to legal fees that were incurred in prior periods. CorMedix recorded net income of $26.0 million, or $0.33 and $0.29 per basic and diluted share, respectively, in the second quarter of 2026, compared with net income of $19.8 million, or $0.29 and $0.28 per basic and diluted share, respectively, in the second quarter of 2025. Also for the second quarter of 2026, CorMedix reported adjusted EBITDA of $58.7 million, compared to adjusted EBITDA of $22.4 million in the second quarter of 2025. The Company reported cash and cash equivalents of $256.7 million at June 30, 2026, 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 CorMedix will host a conference call and webcast today, August 13, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: August 13, 2026 @ 8:30am ET Domestic: 1-844-676-2922 International: 1-412-634-6840 Webcast: Webcast Link About CorMedix CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: 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, as amended (the “Exchange Act”), 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,” “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 including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; Adjusted EBITDA estimates; expectations regarding product utilization and sales; the risk that topline data from CorMedix’s and its partners’ clinical trials, including the ReSPECT study, that CorMedix announces or publishes from time to time may change as more patient data become available or may be interpreted differently if additional data is disclosed; estimates of total addressable market size; failure to successfully conduct future clinical trials, including due to CorMedix’s or its partners’ potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to CorMedix’s product candidates; expectations and timing regarding clinical trials and development, performance expectations and revenue opportunities of CorMedix’s product pipeline; expectations regarding implementation and perceived benefits of CorMedix’s products; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products. 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 most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at 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. In addition, pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. 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 and 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, which 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 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Per Share Data) (Unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, 2026 2025 2026 2025 Revenue and Grant Income: Product sales, net $ 94,341 $ 39,736 $ 216,257 $ 78,818 Contract revenue 4,966 - 8,048 - Grant income 2,624 - 5,053 - Total Revenue and Grant Income $ 101,931 $ 39,736 $ 229,358 $ 78,818 Cost of sales (exclusive of amortization of intangibles) 14,505 1,810 26,510 3,355 Amortization of intangibles 10,300 52 20,600 104 Gross profit $ 77,126 $ 37,874 $ 182,248 $ 75,359 Operating Expenses: Research and development $ 6,684 $ 2,442 $ 13,896 $ 5,635 Selling and marketing 12,447 6,384 24,979 10,858 General and administrative 15,085 9,504 36,805 19,197 Total Operating Expenses $ 34,216 $ 18,330 $ 75,680 $ 35,690 Income From Operations $ 42,910 $ 19,544 $ 106,568 $ 39,669 Other (Expense) Income: Unrealized gain (loss) on marketable equity security 2,546 - (1,000 ) - Change in contingent consideration (6,652 ) - (10,851 ) - Other non-operating (expense) income, net (71 ) 806 (339 ) 1,325 Total Other (Expense) Income (4,177 ) 806 (12,190 ) 1,325 Income before income taxes 38,733 20,350 94,378 40,994 Tax expense 12,745 522 29,789 522 Net Income $ 25,988 $ 19,828 $ 64,589 $ 40,472 Net Income Per Common Share – Basic $ 0.33 $ 0.29 $ 0.81 $ 0.60 Net Income Per Common Share - Diluted $ 0.29 $ 0.28 $ 0.72 $ 0.58 Weighted Average Common Shares Outstanding – Basic 78,444 67,928 78,949 66,593 Weighted Average Common Shares Outstanding – Diluted 92,479 71,919 92,543 70,354 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEET DATA (In Thousands) June 30, December 31, 2026 2025 (Unaudited) (Audited) ASSETS Cash and cash equivalents $ 256,692 $ 144,837 Short-term investments - 3,694 Trade receivables, net 161,305 171,233 Inventories 38,583 29,716 Goodwill and intangible assets 388,474 409,074 Deferred tax assets - 16,276 Other current and long-term assets 58,998 51,312 Total Assets $ 904,052 $ 826,142 Total Liabilities $ 443,219 $ 420,835 Stockholders' Equity 460,833 405,307 Total Liabilities and Stockholders’ Equity $ 904,052 $ 826,142 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) (Unaudited) For the Six Months Ended June 30, 2026 2025 Net income $ 64,589 $ 40,472 Net cash provided by (used in) operating activities $ 128,619 $ 49,728 Net cash (used in) provided by investing activities $ 2,404 $ (20,407 ) Net cash provided by financing activities $ (19,168 ) 89,336 Net Increase (Decrease) in Cash and Cash Equivalents $ 111,855 $ 118,658 Cash, Cash Equivalents and Restricted Cash - Beginning of Period $ 145,825 $ 40,756 Cash, Cash Equivalents and Restricted Cash - End of Period $ 257,680 $ 159,414 CORMEDIX INC. AND SUBSIDIARIES Non-GAAP Reconciliations (In Thousands) (Unaudited) For the Three Months Ended June 30, For the Six Months Ended June 30, 2026 2025 2026 2025 Net income $ 25,988 $ 19,828 $ 64,589 $ 40,472 Adjusted to add (deduct): Interest expense (income) 63 (822 ) 245 (1,379 ) Provision for income taxes 12,745 522 29,789 522 Depreciation and amortization 10,540 163 21,084 325 EBITDA (Non-GAAP) $ 49,336 $ 19,691 $ 115,707 $ 39,940 Adjusted to add (deduct): Change in estimate for sales allowances - - (8,983 ) - Stock-based compensation expense 4,084 2,677 8,666 6,177 Merger related and reorg costs 1,202 - 1,385 (146 ) Other expense 4,114 16 11,945 54 Adjusted EBITDA (Non-GAAP) $ 58,736 $ 22,384 $ 128,720 $ 46,025

AcquisitionFinancial Statement

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 Winthrop Industrie SA	07 Dec 2000
Venous Thromboembolism	China	Sanofi Winthrop Industrie SA	07 Dec 2000

Developing

10 top R&D records.

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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

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04374799 (PRACTICAL-HERO, Pubmed \| Am Heart J)	Phase 3	Occlusion of artery	384	High-dose UFH (50 U/kg)	lpuzotvtem(xrxqyprblm) = xphjlxjmvd wbhqfisaxk (tlsgdseuzm )	Positive	01 Aug 2026
				Low-dose UFH (25 U/kg)	qgurdrjiky(gxihjuwkux) = oyrfqgsgcd mdqbjwhavp (ippudzporw ) View more
ESMO2025	Not Applicable	Thrombosis	42	Low molecular weight heparins	hprsmzgyxh(cezjrewtqk) = wznpcosuoy smgzgtgahk (ddfrrxkxjy ) View more	Positive	17 Oct 2025
				Direct oral anticoagulants	hprsmzgyxh(cezjrewtqk) = buwjymkebm smgzgtgahk (ddfrrxkxjy ) View more
ECCO2025	Not Applicable	Inflammatory Bowel Diseases	107	Low molecular weight Heparin (LMWH)	emhtlohmaz(vxrsgqxejn) = owtdpbcnla hltgozpwdt (gzlleukbqb ) View more	Positive	19 Feb 2025
NCT02984384 (PREVENT CLOT, CTgov)	Phase 3	Thrombosis \| Wounds and Injuries	12,424	Low Molecular Weight Heparin (Low Molecular Weight Heparin (LMWH)-Enoxaparin)	lpjarokqdt = jmunncykjm bwlvgwokab (tfaoazqodz, moprwufhxf - psczwcrlee) View more	-	14 May 2024
				Acetylsalicylic acid (Acetylsalicylic Acid (ASA)-Aspirin)	lpjarokqdt = zgclxzpodg bwlvgwokab (tfaoazqodz, cdzrklezfi - kmnpkhuodd) View more
ASH2023	Not Applicable	Colorectal Cancer	614	Extended duration thromboprophylaxis with low-molecular-weight-heparin	sbpzwtqffr(gbyrjkplly) = xhpyzxmemu qhamuuystf (fuqlgdkshs ) View more	-	10 Dec 2023
				Standard duration thromboprophylaxis	sbpzwtqffr(gbyrjkplly) = wkkztevtve qhamuuystf (fuqlgdkshs ) View more
ERS2023	Not Applicable	Lung Cancer	61	Low molecular weight heparins	hefnffqzex(zdezdypxus) = qbncqhvpzp ttcxuatvkx (ismjjodurf ) View more	Positive	09 Sep 2023
NCT02653092 (CTgov)	Not Applicable	secondary testicular failure \| Infertility \| Obesity ... View more	84	Insulin+Heparin+Dextrose (Aim 1-Administration of FFA in an Acute Model)	fnzqfkyill(iddyljolhm) = uztkbthuxi xgwwrisxgi (mhjsotlrmx, 1.22)	-	01 Jun 2023
				Insulin+Heparin+Dextrose (Aim 2-Hyperinsulinemic Euglycemic Clamp After a Chronic Administration of a Diet)	fnzqfkyill(iddyljolhm) = rchzimrsut xgwwrisxgi (mhjsotlrmx, 1.23)
NCT03894904 (CTgov)	Phase 4	Anesthesia \| Vasospasm	100	Heparin+papaverine (Papaverine Plus Heparin During Procedure, With Rescue Papaverine as Needed)	sratartoje = yaepcptmcg wnilyxbepq (mwdxesrmkl, jxyrpplddf - xevcqxwpkk) View more	-	27 Oct 2022
				Heparin+papaverine (Heparin During Procedure, With Rescue Papaverine as Needed)	sratartoje = pyrfebfxgi wnilyxbepq (mwdxesrmkl, xuuuckmymi - drcjnugjnj) View more
HEPAVALVE (Pubmed \| Int J Cardiol Heart Vasc)	Phase 3	Aortic Valve Stenosis	82	Unfractionated heparin (UH) 50 IU/kg bolus during the procedure	lwxqmnxojr(uslsqwxige) = goccyayijv jrlcexlcwc (fmkylpgnam )	Negative	01 Apr 2022
				Placebo	lwxqmnxojr(uslsqwxige) = nwjqhrmweu jrlcexlcwc (fmkylpgnam )
ACTRN12619000393156 (Pubmed \| Cancer Nurs)	Not Applicable	Neoplasms	61	Heparin (Normal saline)	gkwkahqeoy(wrxpespync) = Adverse events did not differ between groups coowqglxwm (asjqjffxhy )	-	05 Feb 2022

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