Rivaroxaban

2024 marked by strong commercial execution and improved operating leverage Company continues to expect DrugSorb-ATR regulatory decisions from Health Canada and US FDA in 2025 Successful Rights Offering and exercise of Series A Right Warrants strengthens balance sheet Strengthening of clinical portfolio across cardiac surgery and critical care in 2025 with new presentations and publications The Company has now adopted the standard accounting convention of reporting Revenue to only include Product Sales. Grant Income is no longer reported as a component of Revenue PRINCETON, N.J., March 31, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported financial results for the fourth quarter and full year ended December 31, 2024, and recent business highlights. Fourth Quarter 2024 Financial Results Product revenue was $9.2 million, an increase of 25% compared to $7.3 million in Q4 2023. Grant income was $1.0 million compared to $1.3 million in Q4 2023. The Company has historically reported grant income as a component of total revenue and cost of revenue, as well as a reduction of related research and development expense. The Company will now report grant income solely as a reduction of related research and development expense. If the Company had continued its historical reporting, total revenue in Q4 2024 would have been $10.1 million, an increase of 17% compared to $8.7 million in Q4 2023. See reclassification of previously reported amounts in the tables below. Product gross margin was 71% compared to 68% in Q4 2023. Operating loss improved by 61% to $3.7 million compared to $9.6 million in Q4 2023, reflecting higher revenue and a 30% reduction in operating expenses. Net loss was $7.6 million or $0.14 per share, compared to net loss of $6.1 million or $0.13 per share in Q4 2023. Adjusted net loss improved by 78% to $1.7 million or $0.03 per share, compared to an adjusted net loss of $7.8 million or $0.17 per share in Q4 2023. Adjusted EBITDA loss improved by 70% to $2.4 million compared to a loss of $8.1 million in Q4 2023. Total cash, cash equivalents, and restricted cash of $9.8 million at December 31, 2024. Pro forma total cash, including cash, cash equivalents, and restricted cash as if the rights offering and exercise of related Series A Right Warrants had occurred on December 31, 2024, of approximately $17.0 million, compared to $12.2 million at the end of Q3 2024, reflecting $7.3 million of net proceeds from the rights offering and exercise of the Series A Right Warrant, and net cash used in the fourth quarter of approximately $2.5 million compared to $2.7 million in Q3 2024. Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, "We delivered a strong fourth quarter, executing on key initiatives that drove solid performance, advanced our regulatory milestones, and fortified our financial position, setting the stage for what we believe will be a transformational year ahead." Strong Sales Growth and Margins: We closed 2024 on a high note, achieving a 25% increase in Q4 sales compared to the prior year, and 6% sequential growth, culminating in $35.6 million in CytoSorb sales for the full year, representing a 15% year-over-year increase with healthy 71% product gross margins. These results were fueled by disciplined execution of our growth strategy in international markets, enhanced operating leverage, and prudent cash management. Regulatory Momentum and Expanding Market Access: We made significant strides in bringing our DrugSorb™-ATR therapy to patients who need them most. Following the FDA's acceptance of our De Novo application for DrugSorb™-ATR, we entered interactive review - a crucial step toward potential U.S. marketing approval this year. In addition, after obtaining Medical Device Single Audit Program ("MDSAP") certification, we submitted our Medical Device License ("MDL") application to Health Canada that is now in advanced review. We believe we remain on track and continue to expect regulatory decisions this year. Strengthened Balance Sheet: With strong support from our shareholders, we successfully executed our Shareholder Rights Offering and have raised total net proceeds of $7.3 million to date from the offering including the exercise of the Series A Right Warrant. This raise, also allowed for the release of $5.0 million of restricted cash on our balance sheet, and combined, has significantly solidified our financial foundation with an increase in liquidity of $12.3 million. Full Year 2024 Financial Results Product revenue was $35.6 million, an increase of 15% compared to $31.1 million in 2023. Grant income was $3.6 million compared to $5.3 million in 2023. The Company has historically reported grant income as a component of total revenue and cost of revenue, as well as a reduction of related research and development expense. The Company will now report grant income solely as a reduction of related research and development expense. If the company had continued its historical reporting, total revenue would have been $39.2 million, an increase of 8% compared to $36.3 million in 2023. See reclassification of previously reported amounts in the tables below. Product gross margin was 71% compared to 71% in 2023. Operating loss for 2024 improved by 47% to $16.8 million compared to $32 million in 2023 reflecting higher revenue in 2024, and a 22% reduction in operating expenses. Net loss was $20.7 million or $0.38 per share, compared to net loss of $29.2 million or $0.65 per share in 2023. Adjusted net loss for 2024 improved by 53% to $12.7 million or $0.23 per share, compared to an adjusted net loss of $27 million or $0.61 per share in 2023. Adjusted EBITDA loss for 2024 improved by 56% to $11.5 million compared to a loss of $26.2 million in 2023. Dr. Chan continued, "We believe we have a clear and compelling value proposition. Our core business grew 15% in 2024 with more than $35 million in high-margin CytoSorb sales, driven by 28% growth in direct sales outside of Germany and 22% growth in Distributor/Partner sales, which was partially offset by flat growth in direct sales in Germany for the year. Overall, our central messaging of treating the "Right Patient at the Right Time with the Right Dose" of CytoSorb is helping to drive optimized treatment strategies, improve patient outcomes, and accelerate adoption. For example, at this month's International Symposium of Intensive Care and Emergency Medicine Congress in Brussels, Berlot and colleagues from Italy presented compelling new data from a 175-patient retrospective study on septic shock and multiorgan failure. They concluded that early and intensive treatment with CytoSorb led to a statistically significant doubling of survival, compared to predicted mortality. These results, now accepted for publication in the Journal of Intensive Care Medicine, reinforce previously published findings from our CytoSorb Therapy in COVID-19 registry in the journal Critical Care that early and intensive treatment is associated with high survival and shorter time on mechanical support. With a growing body of clinical data from both investigator- and company-sponsored studies, alongside our STAR-T trial and registries like COSMOS and STAR, the CytoSorb best practices knowledge base in the ICU and cardiac surgery is expanding rapidly worldwide. Looking forward, we are encouraged by our commercial progress but are prioritizing a return to sales growth in Germany, our largest market, which was flat for the second year in a row. Entering 2025, we initiated a significant reorganization of our direct sales team and strategy in Germany, including a rebalancing of territories and hospital accounts, with the goal of restoring sales growth through deeper customer engagement, more effective market development, and improved sales representative productivity. Because of the effect of these changes, we expect a short-term disruption in Germany sales that will result in modestly lower product sales overall in the first quarter compared to a year ago. However, we expect these actions will yield improved results in the second half of this year with the intent to manage our total core business toward breakeven. Meanwhile, with the appropriate marketing approvals, we are excited by the potential near-term growth opportunity in the U.S. and Canada of addressing the serious perioperative bleeding problem caused by blood thinners like Brilinta® (ticagrelor, AstraZeneca) in patients undergoing coronary artery bypass graft ("CABG") surgery for which we have received FDA Breakthrough Designation. Brilinta®, a widely used antiplatelet drug, is given to heart attack patients to prevent further clotting. However, if these patients require CABG surgery, current guidelines recommend delaying the procedure for three to five days to allow the drug to naturally wash out—leading to prolonged hospital stays, increased costs, and a heightened risk of life-threatening complications. Blood purification with DrugSorb-ATR represents a unique solution that can enable patients to undergo CABG surgery safely and quickly, without having to wait at risk. The intent is to both reduce serious bleeding complications while reducing the burden on hospital resources. We estimate the total addressable market for DrugSorb-ATR in the U.S. and Canada will grow from $300 million today to over $1 billion as Brilinta becomes generic, DrugSorb-ATR establishes Brilinta as the only reversible oral antiplatelet, and we expand into other blood thinners and surgical applications. As we await decisions from the FDA and Health Canada, we are preparing to execute a controlled market release at key clinical trial sites if approved. This initial stage is expected to last a few months and will allow us to gather real-world feedback, validate assumptions, and refine our commercialization strategy for a broader national launch. Our DrugSorb-ATR launch team leverages years of commercial expertise and has initiated pre-market launch planning, including engaging with leading U.S. and Canadian key opinion leaders, recruiting essential talent, managing numerous market access activities, and developing a clear value proposition for patients, surgeons, and hospitals. Visibility and thought leadership are key pillars of our DrugSorb-ATR launch strategy. Over the next several months, impactful new data will be presented at major cardiovascular conferences that underscore the clinical benefits of antithrombotic removal in cardiac surgery. At the American College of Cardiology Conference in Chicago, the largest cardiovascular event in North America, STAR-T Principal Investigator, Dr. Michael Gibson, just presented an important pooled data analysis from the STAR-T trial and the international STAR Registry demonstrating that the bleeding reductions after CABG surgery observed in the controlled STAR-T trial also extend into real-world clinical practice. At the Society of Cardiovascular Anesthesiologists 47th Annual Meeting in Montreal in April, Dr. David Mazer, a pioneer in perioperative blood conservation and a STAR-T Executive Committee member, will lead a roundtable discussion on the integration of DrugSorb-ATR into perioperative blood management protocols. At EuroPCR in Paris this May, Professor Robert Storey will present what we believe to be some of the most compelling blood thinner removal evidence to date, comparing bleeding rates after CABG in Brilinta® patients operated with or without our device. This latest analysis with updated data from the STAR Registry clearly demonstrates the significant bleeding reductions associated with the use of our device in contemporary real-world practice. At the Canadian Society of Cardiac Surgery conference in Montreal in May, Dr. Richard Whitlock, the STAR-T Canadian Principal Investigator, will host a symposium on the STAR-T study results, outlining DrugSorb-ATR's clinical and economic value proposition in Canadian hospital practice. Finally, at the European Society of Cardiology Heart Failure meeting in Belgrade in May, a new study will be presented demonstrating how DrugSorb-ATR successfully prevented bleeding complications in patients on Brilinta® or other direct oral anticoagulants undergoing emergency, complex heart transplantation surgery." Dr. Chan concluded, "With an established foundation of commercial sales, strong regulatory progress, and enhanced financial stability, we believe we are very well-positioned to take advantage of a host of new opportunities this year. As we advance our global commercialization strategy and prepare for the potential launch of DrugSorb-ATR, we remain committed to delivering life-saving solutions that improve patient outcomes and drive long-term value for our shareholders." Business Outlook As discussed, we anticipate a multitude of opportunities to potentially expand our business both internationally and in the United States and Canada this year. To address flat product sales in our largest market of Germany, we restructured the direct sales team and strategy, including a realignment of sales territories and accounts, to drive a return to sales growth in this key country. Because of the impact of these changes, we expect a short-term disruption in German sales and a modest decline in overall product sales for Q1 2025, both sequentially and compared to Q1 2024. However, we expect these actions will help to improve results in the second half of this year with the intent to manage our core business toward breakeven. Q4 and Full Year 2024 Earnings Conference Call CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session with the following information: Date: Monday, March 31, 2025 Time: 4:30 PM ET North American toll-free: 1-800-836-8184 International toll: 1-646-357-8785 Live webcast link: It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations section of the Company's website at About Non-GAAP Financial Measures To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively. Additionally, we have provided a Proforma Cash balance as of December 31, 2024, reflecting the proceeds, net of related fees, for the Rights Offering and Exercise of the Series A Warrant which were received in the first quarter of 2025 as if the net proceeds had been received as of December 31, 2024. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of our business, the Company's cash available for operations, and the Company's ability to meet future capital expenditure and working capital requirements. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo medical device application to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Data presented at the American College of Cardiology Annual Scientific Session show that the reduction of bleeding with abelacimab compared to rivaroxaban (Xarelto) was even greater in patients ≥75 years old compared to younger patients Another analysis from AZALEA-TIMI 71 shows abelacimab, as compared to rivaroxaban (Xarelto), was associated with a greater absolute benefit in patients who are at higher risk for bleeding CAMBRIDGE, Mass., March 29, 2025–Anthos Therapeutics, Inc., a transformative, clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiovascular metabolic diseases, is presenting two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. These data will be presented today during the moderated poster sessions from 2:30-4:30pm CT. In the first analysis, the safety of abelacimab, a novel Factor XI inhibitor, was compared to rivaroxaban, a direct oral anticoagulant (DOAC), by patient age. Inhibition of Factor XI with abelacimab significantly reduced the relative risk of major or clinically relevant non-major (CRNM) bleeding compared with rivaroxaban regardless of age, with potential for greater absolute risk reduction (ARR) with older patients. The ARR in patients 75 years of age and older was 6.2% compared to 4.2% in patients less than 75 years. In addition, abelacimab consistently reduced bleeding risk in patients 75 years of age and older regardless of renal function, body mass index (BMI), and the use of concomitant antiplatelet therapy. “Patients with atrial fibrillation, particularly older patients, are frequently at a high risk of bleeding. There is a need for safer anticoagulants that can prevent thrombotic events while minimizing excess bleeding,” said Christian T. Ruff, MD, MPH, senior investigator of TIMI Group, director General Cardiology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School. “These data show that abelacimab significantly reduced the risk of major or CRNM bleeding, particularly among people over 75 who are vulnerable to such risks, and, if approved, could be a safer alternative for patients needing anticoagulation therapy.” In the second analysis, the safety of abelacimab was compared to rivaroxaban across a spectrum of bleeding risk, which was determined by using the direct oral anticoagulant (DOAC) score, a clinical tool leveraged to assess the risk of bleeding in patients who are prescribed DOACs. In patients with atrial fibrillation, abelacimab reduced rates of bleeding relative to rivaroxaban regardless of bleeding risk, with greater absolute safety benefit in those at higher bleeding risk. In the rivaroxaban arm, the rates of major or CRNM bleeding per 100 patient years increased stepwise across risk categories from 5.6% in the low risk category to 21.2% in the very high risk category. In contrast, the rates of bleeding in patients in the pooled abelacimab arm were 2.5% in the low-risk category to 7.1% in the very high-risk category. The ARR increased from 3.1% in the low risk category to 14.1% in the very high risk category (p-trend for ARR <0.001). These data suggest that, if approved, abelacimab may be especially attractive in patients with atrial fibrillation who are at high bleeding risk. “Research shows that 40% of patients with atrial fibrillation are not receiving optimal treatment when it comes to anticoagulation, in large part due to a fear of bleeding. This includes people living with atrial fibrillation who have a higher risk of bleeding, such as the elderly, patients taking anti-platelet agents, and those with other co-morbidities,” said Dan Bloomfield, MD, chief medical officer of Anthos Therapeutics. “These results suggest that abelacimab may be safe across the spectrum of bleeding risk and may make it possible to anticoagulate some of the most vulnerable populations who otherwise would not be treated and therefore left unprotected from the risk of stroke.” Full results of the AZALEA-TIMI 71 study were published in January of this year in the New England Journal of Medicine (NEJM) and demonstrated a 62% reduction in major or CRNM bleeding with abelacimab 150 mg compared to rivaroxaban 20 mg in patients with atrial fibrillation. Abelacimab is currently in Phase 3 development with the lead indication for the prevention of stroke and systemic embolism in patients with atrial fibrillation (LILAC-TIMI 76), in addition to two studies in patients with cancer-associated thrombosis (ASTER and MAGNOLIA). Data from these trials are expected in the second half of 2026. AZALEA-TIMI 71 Study of Bleeding Risk by Age Relevant Study Details: Both abelacimab doses (90 mg and 150 mg) were pooled for this analysis. Cox proportional hazards were used to examine the primary outcome of major/CRNM bleeding with an interaction term for treatment*age (≥75 vs <75 yrs). Of 1,287 patients, 625 (49%) were ≥75 yrs at baseline. Patients ≥75 had lower BMI (28 vs. 32 kg/m2) and were less likely to be on antiplatelet therapy (17% vs 31%), but more likely to have Creatinine clearance (CrCl) ≤50 mL/min (33% vs. 8%) compared with younger patients (p<0.001 for each). Both abelacimab doses (90 mg and 150 mg) were pooled for this analysis. Cox proportional hazards were used to examine the primary outcome of major/CRNM bleeding with an interaction term for treatment*age (≥75 vs <75 yrs). Of 1,287 patients, 625 (49%) were ≥75 yrs at baseline. Patients ≥75 had lower BMI (28 vs. 32 kg/m2) and were less likely to be on antiplatelet therapy (17% vs 31%), but more likely to have Creatinine clearance (CrCl) ≤50 mL/min (33% vs. 8%) compared with younger patients (p<0.001 for each). AZALEA-TIMI 71 Study of Patient-Specific Bleeding Risk Relevant Study Details: Both abelacimab doses (90 mg and 150 mg) were pooled for this analysis. Patient-specific bleeding risk was categorized using the previously validated DOAC score. Overall, 8%, 33%, 37%, 16% and 5% of patients were categorized as very low (0-3), low (4-5), moderate (6-7), high (8-9) and very high (10) bleeding risk, respectively. Both abelacimab doses (90 mg and 150 mg) were pooled for this analysis. Patient-specific bleeding risk was categorized using the previously validated DOAC score. Overall, 8%, 33%, 37%, 16% and 5% of patients were categorized as very low (0-3), low (4-5), moderate (6-7), high (8-9) and very high (10) bleeding risk, respectively. About Anthos Therapeutics Founded by Blackstone Life Sciences (BXLS) in 2019, Anthos Therapeutics is a transformative, clinical-stage biopharmaceutical company with the exclusive global rights from Novartis Pharma AG to develop, manufacture and commercialize abelacimab. For more information, visit the Company’s website and follow on Twitter and LinkedIn. About the AZALEA-TIMI 71 Study Launched in February 2021, the AZALEA-TIMI 71 study enrolled 1,287 patients across 95 global study sites, including the U.S. and Canada, Europe and Asia. With a median follow-up of 2.1 years, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor compared to a standard-of-care anticoagulant. About Abelacimab Abelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to Factor XI to block its activation and prevent the generation of the activated form (Factor XIa). This mimics natural Factor XI deficiency, which is associated with protection from thromboembolic disease.1 As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low.2 There is no need to adjust the dose based on age or renal/hepatic status.3 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.4 Abelacimab is the only Factor XI inhibitor being studied for both conditions. If approved, abelacimab is planned to be dosed subcutaneously (SC) monthly by patients with atrial fibrillation using an autoinjector to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.5 In a PK/PD study, abelacimab administered by IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 The results of the AZALEA-TIMI 71 study, published in the January 23, 2025, issue of New England Journal of Medicine (NEJM) showed a 62% reduction in major or clinically relevant non-major bleeding with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P<0.001, HR 0.38, 95% Cl 0.24–0.60). Data also showed a 62% reduction in major bleeding alone with abelacimab 150 mg vs. rivaroxaban 20 mg (P=0.001, HR 0.33, 95% CI 0.16-0.66) and an 89% reduction in gastrointestinal (GI) bleeding).7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the DOAC Score The direct oral anticoagulant (DOAC) score is a clinical tool used to assess the risk of bleeding in patients who are prescribed DOACs, a class of drugs used to prevent and treat thromboembolic disorders such as stroke in atrial fibrillation. The DOAC score helps clinicians evaluate the safety and appropriateness of DOAC therapy for individual patients by considering factors such as age, renal function, history of bleeding, and concurrent use of other medications that may increase bleeding risk. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the potential benefit of abelacimab and our goals to further develop and commercialize abelacimab. All statements, other than statements of historical facts, contained in this press release, including statements regarding the company’s strategy, future operations, future financial position, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “become,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “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. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. Media Contact: media@anthostherapeutics.com 1. Goodman et al. Crit Pathways in Cardiol. June 2024. 2. Hsu et al. J Am Coll Cardiol. Aug. 2021 3. Hsu et al. J Am Coll Cardiol. Aug. 2021 4. Hsu et al. J Am Coll Cardiol. Aug. 2021 5. TIMI Study Group website, AZALEA 71 6. Yi BA et al. J Thromb Haemost. Oct. 2021 7. Ruff C et al. N Engl J Med. Jan. 2025