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CytoSorbents Reports Third Quarter 2025 Financial Results and Provides Business Update

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CytoSorbents (NASDAQ: CTSO) reported Q3 2025 revenue of $9.5M, up 10% year-over-year, with gross margin 70%. Operating loss improved to $2.9M and net loss was $3.2M ($0.05/share); adjusted net loss was $2.6M ($0.04/share). Cash and equivalents were $9.1M on Sept 30, 2025, proforma $11.6M assuming an additional $2.5M term loan.

The company amended its credit agreement to provide an immediate $2.5M term loan, extended interest-only to Dec 31, 2026, and issued 1,428,571 warrants at $0.70. Workforce reduction of ~10% and a restructuring charge up to $900k aim to reach operating cash-flow breakeven in Q1 2026. DrugSorb-ATR De Novo submission is planned in Q1 2026 with an anticipated decision by mid-2026.

CytoSorbents (NASDAQ: CTSO) ha riportato ricavi Q3 2025 di 9,5 milioni di dollari, in crescita del 10% rispetto all'anno precedente, con margine lordo del 70%. La perdita operativa è migliorata a 2,9 milioni di dollari e la perdita netta è stata di 3,2 milioni di dollari (0,05 dollari/azione); la perdita netta rettificata è stata di 2,6 milioni di dollari (0,04 dollari/azione). Le disponibilità liquide e equivalenti erano di 9,1 milioni di dollari al 30 settembre 2025, pro forma 11,6 milioni di dollari assumendo un ulteriore prestito a termine di 2,5 milioni di dollari. L'azienda ha modificato il proprio accordo di credito per fornire immediatamente un prestito a termine di 2,5 milioni di dollari, estendere i mesi di interessi solo a pagare a 31 dicembre 2026, e hanno emesso 1.428.571 warrant al prezzo di 0,70 dollari. Il taglio del personale di circa il 10% e una carica di ristrutturazione fino a 900k mirano a raggiungere il pareggio di cassa operativo nel Q1 2026. La presentazione De Novo di DrugSorb-ATR è pianificata nel Q1 2026 con una decisione prevista entro la metà del 2026.

CytoSorbents (NASDAQ: CTSO) reportó ingresos del 3T 2025 de 9,5 millones de dólares, un aumento del 10% interanual, con un margen bruto del 70%. La pérdida operativa mejoró a 2,9 millones de dólares y la pérdida neta fue de 3,2 millones de dólares (0,05/acción); la pérdida neta ajustada fue de 2,6 millones de dólares (0,04/acción). El efectivo y equivalentes fue de 9,1 millones de dólares al 30 de septiembre de 2025, proforma 11,6 millones asumiendo un préstamo a término adicional de 2,5 millones. La empresa enmendó su acuerdo de crédito para proporcionar de inmediato un préstamo a término de 2,5 millones, extendió el periodo de solo intereses hasta el 31 de diciembre de 2026 y emitió 1.428.571 warrants a 0,70 dólares. La reducción de personal de ~10% y una carga de reestructuración de hasta 900k buscan alcanzar el punto de equilibrio de flujo de efectivo operativo en el Q1 2026. La presentación De Novo de DrugSorb-ATR está planificada para el Q1 2026 con una decisión prevista para mediados de 2026.

CytoSorbents (NASDAQ: CTSO)는 2025년 3분기 매출이 950만 달러로 전년 동기 대비 10% 증가했으며, 총이익률 70%를 기록했습니다. 영업손실은 290만 달러로 개선되었고 순손실은 320만 달러(주당 0.05달러)였으며, 조정 순손실은 260만 달러(주당 0.04달러)였습니다. 현금 및 현금성자산은 2025년 9월 30일 기준 910만 달러였고, 추가로 250만 달러의 만기 대출을 가정하면 프로 포마는 1160만 달러입니다. 회사는 즉시 250만 달러의 만기 대출을 제공하고, 이자 지급만 가능하도록 2026년 12월 31일까지를 연장했으며, 1428571주0.70달러에 발행했습니다. 약 10%의 인력 감축과 최대 90만 달러의 구조조정 비용은 2026년 1분기에 영업현금흐름 손익분기점을 달성하는 것을 목표로 합니다. DrugSorb-ATR De De Novo 제출은 2026년 1분기에 계획되어 있으며, 2026년 중반까지의 결정이 예상됩니다.

CytoSorbents (NASDAQ: CTSO) a annoncé un chiffre d'affaires pour le T3 2025 de 9,5 millions de dollars, en hausse de 10% d'une année sur l'autre, avec une marge brute de 70%. La perte opérationnelle s'est améliorée à 2,9 millions de dollars et la perte nette a été de 3,2 millions de dollars (0,05 $/action) ; la perte nette ajustée était de 2,6 millions de dollars (0,04 $/action). La trésorerie et les équivalents s'élevaient à 9,1 millions de dollars au 30 septembre 2025, pro forma 11,6 millions en supposant un prêt à terme additionnel de 2,5 millions. L'entreprise a modifié son accord de crédit pour fournir immédiatement un prêt à terme de 2,5 millions, a allongé la période d'intérêts uniquement jusqu'au 31 décembre 2026 et a émis 1 428 571 warrants à 0,70 $ chacun. Une réduction d'effectifs d'environ 10% et une charge de restructuration pouvant atteindre 900k visent à atteindre l'équilibre opérationnel de trésorerie au 1er trimestre 2026. La soumission De Novo de DrugSorb-ATR est planifiée pour le 1er trimestre 2026 avec une décision attendue d'ici la mi-2026.

CytoSorbents (NASDAQ: CTSO) meldete im Q3 2025 einen Umsatz von 9,5 Mio. USD, ein Anstieg von 10% gegenüber dem Vorjahr, bei einer Bruttomarge von 70%. Der operative Verlust verbesserte sich auf 2,9 Mio. USD und der Nettverlust betrug 3,2 Mio. USD (0,05 USD/Aktie); der bereinigte Nettolose war 2,6 Mio. USD (0,04 USD/Aktie). Kassenbestand und Äquivalente betrugen zum 30. September 2025 9,1 Mio. USD, pro forma 11,6 Mio. USD unter der Annahme eines zusätzlichen 2,5 Mio. USD-Term-Loans. Das Unternehmen hat seine Kreditvereinbarung angepasst, um sofort einen Term Loan über 2,5 Mio. USD bereitzustellen, die Zinszahlungen bis zum 31.12.2026 auf Zinszahlungen beschränkt zu verlängern und 1.428.571 Warrants zum Preis von 0,70 USD auszugeben. Eine Personalreduzierung von ca. 10% und eine Restrukturierungskostenlast von bis zu 900 Tsd. USD sollen im Q1 2026 den operativen Cashflow-Breakeven erreichen. Die De Novo-Einreichung von DrugSorb-ATR ist für das Q1 2026 geplant, mit einer Entscheidung voraussichtlich bis zur Mitte 2026.

سيترسوربنتس (ناسداك: CTSO) أبلغت عن إيرادات الربع الثالث 2025 بلغت 9.5 مليون دولار، بارتفاع 10% على أساس سنوي، وهوامش إجمالي 70%. الخسارة التشغيلية تحسّنت إلى 2.9 مليون دولار والخسارة الصافية كانت 3.2 مليون دولار (0.05 دولار/سهم)؛ الخسارة الصافية المعدلة كانت 2.6 مليون دولار (0.04 دولار/سهم). النقد والنقد المعادل كان 9.1 مليون دولار في 30 سبتمبر 2025، وبافتراض قرض إضافي بقيمة 2.5 مليون دولار بُناءً على الوضع الافتراضي ستكون القيمة 11.6 مليون دولار. عدّلت الشركة اتفاقها الائتماني لتوفير قرضًا نهائيًا بقيمة 2.5 مليون دولار فورًا، وامتدَّت فترة دفع الفوائد حتى 31 ديسمبر 2026، كما تم إصدار 1,428,571 عقد خيار شراء بسعر 0.70 دولار لكل واحد. تقليل القوى العاملة بنحو 10% وتكاليف إعادة هيكلة تصل إلى 900 ألف دولار يهدف إلى الوصول إلى التعادل النقدي التشغيلي في الربع الأول من 2026. من plan تقديم DrugSorb-ATR De Novo في الربع الأول من 2026 مع قرار متوقع بحلول منتصف 2026.

Positive
  • Revenue +10% year-over-year to $9.5M
  • Gross margin 70% in Q3 2025 (vs 61% prior year)
  • Adjusted EBITDA loss improved to -$2.0M
  • Amended credit adds $2.5M immediate term loan and extends interest-only
Negative
  • Cash declined to $9.1M on Sept 30, 2025 (from $11.7M on June 30, 2025)
  • Total proforma debt drawn of $17.5M as of Sept 30, 2025
  • Reported net loss $3.2M and operating loss $2.9M in Q3 2025
  • Restructuring will incur up to $900k in charges; ~10% workforce reduction
  • Access to an additional $2.5M and extended interest-only period depends on FDA approval of DrugSorb-ATR

Insights

Revenue and margins improved, liquidity extended, and FDA re-submission defines near-term value drivers; cash burn and approval dependency remain key risks.

CytoSorbents reported $9.5 million revenue in Q3 2025, up 10% year‑over‑year, gross margin rising to 70%, and an operating loss narrowing to $2.9 million. Management implemented a ~10% workforce reduction with a one-time charge of up to $900,000, and reported cash of $9.1 million (proforma $11.6 million if the new $2.5 million tranche were drawn). Proforma debt drawn under the amended facility stands at $17.5 million.

The amended credit agreement provides immediate liquidity and extends the interest‑only period to December 31, 2026, with an additional $2.5 million and a further extension conditional on U.S. FDA approval of DrugSorb‑ATR. The Company expects a pre‑submission meeting in late Q4 2025 or early Q1 2026, plans a De Novo filing in Q1 2026, and anticipates a regulatory decision by mid‑2026.

Operationally, improved distributor and direct market sales and higher margins reduced losses and improved adjusted EBITDA. The path to break‑even was accelerated to Q1 2026 via cost cuts, but liquidity and debt remain tied to the timing and outcome of the FDA process. Key items to watch are the FDA meeting timing and the De Novo filing in Q1 2026, the mid‑2026 regulatory decision, quarterly cash burn versus the stated targets, and realization of the additional $2.5 million tranche linked to approval.

  • Third quarter 2025 revenue of $9.5 million, up 10% year-over-year
  • Amended credit agreement with Avenue Capital Group which strengthens our balance sheet with an additional $2.5 million of cash, and extends the interest only-period through December 31, 2026, with an additional $2.5 million available and an additional extension of the interest-only period to June 30, 2027 with DrugSorb-ATR FDA marketing approval
  • Implemented Workforce and Cost Reduction Program to accelerate path to cash-flow breakeven to Q1 2026
  • Submitted DrugSorb™-ATR De Novo pre-submission package to FDA, with meeting expected in Q4 2025 or early Q1 2026, followed by planned submission of new De Novo application in Q1 2026, and anticipated regulatory decision mid-2026

PRINCETON, N.J., Nov. 13, 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 third quarter ended September 30, 2025, and recent business highlights. 

Third Quarter 2025 Financial Results

  • Revenue was $9.5 million, an increase of 10%, or 4% on a constant currency basis, compared to $8.6 million in Q3 2024. Growth was led by record performance in our distributor territories and near-record performance in direct sales outside Germany.
  • Gross margin in Q3 2025 was 70% compared to 61% in Q3 2024. Last year's gross margin was affected by a planned production slow-down to rebalance inventory and a temporary manufacturing issue that was resolved during Q3 2024.
  • Operating loss improved to $2.9 million, compared to $4.8 million in Q3 2024 due to improved gross margins and lower operating expenses
  • Net loss was $3.2 million or $0.05 per share, compared to a net loss of $2.8 million or $0.05 per share in Q3 2024.
  • Adjusted net loss improved to $2.6 million or $0.04 per share, compared to an adjusted net loss of $4.5 million or $0.08 per share in Q3 2024.
  • Adjusted EBITDA loss improved to $2.0 million compared to a loss of $3.6 million in Q3 2024.
  • Total cash, cash equivalents, and restricted cash of $9.1 million on September 30, 2025, compared to $11.7 million as of June 30, 2025, reflecting net operating cash burn in the quarter of $2.6 million.
  • Proforma cash, cash equivalents, and restricted cash was $11.6 million on September 30, 2025, as if the additional $2.5 million term loan capital made available through the amended credit agreement with Avenue Capital Group were drawn on September 30, 2025. Total proforma debt drawn under the agreement as of September 30, 2025, is $17.5 million.

"We are pleased with our third quarter results led by record sales in our distributor territories, strong sales in our other direct markets, and improved operating margins and cash efficiencies across the company," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "This strong sales growth was partially offset by a decline in our direct German market where we continue our proactive reorganization of our commercial team and selling approach which we believe will lead to improved performance and execution in 2026."

Workforce and Cost Reduction Program Expected to Accelerate Q1 2026 Cash Flow Breakeven 
Today, the Company announced the implementation of a strategic Workforce and Cost reduction plan to further reduce costs, optimize operations, and accelerate the path to cash-flow profitability. This initiative follows a comprehensive internal review of its cost structure and operating model. As part of the strategic plan, CytoSorbents reduced its workforce by approximately 10%, reduced and realigned production and operating expenses, and now expects to reach operating cash flow break-even in the first quarter of 2026.  The Company expects to record a charge of up to $900,000 that will include severance and other charges related to the restructuring.  The estimated costs that the Company expects to incur, and the timing thereof, are subject to a number of assumptions, and actual amounts may differ materially.

Amended Credit Agreement Strengthens Balance Sheet and Extends Interest-only Period
Today, the Company announced that it has amended its prior credit agreement with Avenue Capital Group effective November 13, 2025.  The amendment provides immediate funding of an additional $2.5 million in term loan capital and an extension of the interest-only period to December 31, 2026 (from July 1, 2026), followed by equal monthly installments of principal plus accrued and unpaid interest until maturity on July 1, 2027.  The Amendment requires that the Company maintain certain operating cash burn targets only until U.S. FDA marketing approval of DrugSorb-ATR is achieved. The Company will have access to an additional $2.5 million in term loan capital with a further six-month extension of the interest-only period to the July 1, 2027 maturity date upon the U.S. FDA approval of DrugSorb-ATR in 2026.  Under the terms of the amendment, the Company issued additional warrants to Avenue Capital Group to purchase 1,428,571 shares of the Company's common stock for cash at the exercise price of $0.70, which expire on November 13, 2030. The number of warrants and exercise price are fixed.

DrugSorb™-ATR Regulatory Updates
On September 16, 2025, the Company announced plans to submit a new De Novo application for DrugSorb-ATR to the U.S. FDA.  This decision followed an FDA appeal meeting and final determination that upheld the prior denial of the original application.  Notably, the FDA raised no concerns regarding device safety but requested additional information to support the Company's desired label indication.

The new De Novo submission will include analyses of real-world data demonstrating DrugSorb-ATR's effectiveness in clinical practice - data that were not available at the time of the original filing and therefore not eligible for inclusion in the prior review.  The Company believes these new data underscore DrugSorb-ATR's strong clinical performance and reinforce its favorable benefit-to-risk profile, particularly when combined with the comprehensive clinical evidence previously submitted.

To advance this process, the Company submitted a pre-submission meeting request with supporting documentation to the FDA on November 7, 2025.  A formal meeting with the Agency is expected in late Q4 2025 or early 2026 to confirm the requirements for the new application, followed by the formal De Novo submission in Q1 2026.  A regulatory decision is anticipated by mid-2026, following the typical 150-day review period.  Based on discussions with the FDA, the review is expected to focus solely on the remaining open items from the initial submission and may be expedited under the device's FDA Breakthrough Device Designation, which allows for priority and interactive review.

Dr. Chan continued, "We are pleased with the progress we are making on key strategic initiatives including strong sales in our existing core business, gross margins of over 70%, progress toward DrugSorb-ATR approval and launch in the US, and the expectation to bring the Company to cash flow breakeven in the first quarter.  This progress is further supported by the amendment of our credit agreement which we believe provides sufficient liquidity and flexibility to continue supporting our strategic growth initiatives.  We appreciate the partnership with our lender – Avenue Capital Group – and look forward to continuing to execute our strategy."  

"We are happy to restructure the existing loan facility and provide more capital to CytoSorbents. We have been very impressed with their OUS revenue growth and how they have been impacting patients' lives and want to be strong capital partners," stated Chad Norman, Sr. Portfolio Manager, Avenue Capital Group.

A Wealth of New Clinical Data
Meanwhile, recent clinical data publications and presentations continue to reinforce the positive clinical impacts our therapies are having around the world.  Select recent examples include:

  • On September 10, 2025, in commemoration of Sepsis Awareness Month and World Sepsis Day, Dr. Chan hosted a special webinar featuring the clinical insights of leading international critical care experts entitled "Turning the Tide on Sepsis and Septic Shock: Real World Insights with CytoSorb". This webinar highlighted CytoSorb's broad mechanisms of action in helping to manage the complex pathophysiology of sepsis and septic shock, with a focus on controlling deadly inflammation, stabilizing organ function, promoting a reversal of capillary leak, and enabling fluid removal. Recent exciting publications reinforce the importance of early and intensive CytoSorb treatment in septic shock, particularly the retrospective study of 175 septic shock patients (Berlot, et al. 2025), while the first meta-analysis of 744 patients with septic shock from Charité Berlin Hospital demonstrated that CytoSorb usage in these patients led to significant reductions in both in-hospital and 28-30-day mortality (Steindl, et al. 2025). Access the entire webinar here, or the white paper here.
  • At the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in October, Prof. Richard Whitlock (McMaster University) presented the first randomized controlled trial data on the "Intraoperative Removal of Direct Oral Anticoagulants in Patients Undergoing Urgent Cardiothoracic Surgery" where intraoperative use of DrugSorb™-ATR in cardiac surgery significantly reduced levels of direct oral anticoagulants (DOACs), such as Eliquis® (apixaban, Pfizer/Bristol Myers Squibb) and Xarelto® (rivaroxaban, Janssen/Bayer), compared to sham controls. This supports the notion that our technology can be a "one-size fits all" countermeasure for different classes of blood thinners in cardiac surgery.
  • In a presentation titled, "Dual Antiplatelet Therapy (DAPT) and Urgent CABG in Acute Coronary Syndrome (ACS): Impact of P2Y12 Inhibitor Choice & Intraoperative Hemoadsorption on Perioperative Bleeding: Comparative Real-World Analysis," Professor Matthias Thielmann (Westerman Heart & Vascular Center) presented compelling real-world data from a real-world study demonstrating that among heart attack patients undergoing urgent CABG, combining dual antiplatelet therapy (aspirin + ticagrelor) with intraoperative use of CytoSorb® reduces severe bleeding complications compared with patients treated with aspirin + Plavix (clopidogrel) without CytoSorb.

Dr. Chan concluded, "With a rapidly expanding foundation of clinical evidence that now encompasses hundreds of peer-reviewed publications, real-world data, and compelling success stories, CytoSorbents' broad-spectrum blood purification technology continues to advance as a powerful tool for removing harmful substances and redefine how some of the most complex and life-threatening conditions are treated. We were especially pleased with the strong response to our World Sepsis Day Global Webinar on September 10th, which underscored the critical and evolving role of early, intensive use of CytoSorb® alongside traditional antibiotic therapy in managing sepsis and septic shock. Looking ahead, we remain committed to expanding our clinical programs across all applications to further improve outcomes for patients, and to support the healthcare workers around the world who care for them."

Third Quarter 2025 Earnings Conference Call

CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session with the following information:

Date: Thursday November 13, 2025
Time: 4:30 PM ET
Live webcast link:https://app.webinar.net/g7AGWegQ613 

It is recommended that participants join 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 https://ir.cytosorbents.com/

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 Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Share, respectively. 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.  For a reconciliation of non-GAAP financial measures to the most comparable GAAP measure, see the reconciliation included in the financial tables.  All non-GAAP adjustments are presented pre-tax.

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 storm and cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and 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 nearly 300,000 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 surgery.  The Company is actively pursuing regulatory approval of DrugSorb-ATR with the U.S. FDA and will pursue regulatory approval with Health Canada with better visibility from the FDA.  DrugSorb-ATR is not yet granted or approved in either the U.S. or Canada.

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 https://ir.cytosorbents.com/  and follow us on Facebook and X and LinkedIn.

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, ability to successfully obtain U.S. FDA and Health Canada marketing authorization or approval, our ability to complete our strategic workforce and cost reduction plan to reduce costs, optimize operations, and achieve cash-flow break-even in the first quarter of 2026, our ability to appropriately finance the Company, 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.

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U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
305 College Road East
Princeton, NJ 08540
pmariani@cytosorbents.com 

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare 
ir@cytosorbents.com 

PART I — FINANCIAL INFORMATION

  • Item 1. Financial Statements.

CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)



September 30, 


December 31, 



2025


2024



(unaudited)



ASSETS







Current Assets:







Cash and cash equivalents


$

7,536


$

3,280

Restricted cash, current





5,000

Accounts receivable, net of allowances of $134 and $158 as of September
     30, 2025 and December 31, 2024, respectively



7,427



7,320

Inventories



4,002



2,733

Prepaid expenses and other current assets



2,348



3,271

Total current assets



21,313



21,604








Property and equipment - net



8,193



9,002

Restricted cash



1,522



1,484

Right-of-use asset



11,075



11,511

Other assets



3,647



3,771

Total assets


$

45,750


$

47,372








LIABILITIES AND STOCKHOLDERS' EQUITY







Current Liabilities:







Accounts payable


$

3,035


$

3,340

Accrued expenses and other current liabilities



6,559



6,032

Lease liability – current portion



518



453

Total current liabilities



10,112



9,825

Lease liability, net of current portion



12,051



12,444

Long-term debt



14,567



13,996

Total liabilities



36,730



36,265








Commitments and Contingencies














Stockholders' equity







Preferred Stock, par value $0.001, 5,000,000 shares authorized; no shares
      issued and outstanding as of September 30, 2025 and December 31, 2024





Common Stock, par value $0.001, 100,000,000 shares authorized as of
     September 30, 2025 and December 31, 2024; 62,794,305 and 54,830,146
     shares issued and outstanding as of September 30, 2025 and December
     31, 2024, respectively



63



55

Additional paid-in capital



319,511



310,809

Accumulated other comprehensive income (loss)



(3,844)



4,252

Accumulated deficit



(306,710)



(304,009)

Total stockholders' equity



9,020



11,107

Total liabilities and stockholders' equity


$

45,750


$

47,372


See accompanying notes to condensed consolidated financial statements

 

CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(in thousands, except share and per share data)



Three Months Ended September 30, 


Nine Months Ended September 30, 



2025


2024


2025


2024



(Unaudited)


(Unaudited)


(Unaudited)


(Unaudited)

Revenue


$

9,485


$

8,613


$

27,829


$

26,444

Cost of goods sold



2,819



3,357



8,142



7,812

Gross profit



6,666



5,256



19,687



18,632














Operating expenses













Research and development, net of grant income



918



1,826



3,842



5,592

Selling, general and administrative



8,610



8,260



26,209



26,097

Total operating expenses



9,528



10,086



30,051



31,689

Loss from operations



(2,862)



(4,830)



(10,364)



(13,057)














Other income (expense)













Interest expense, net



(645)



(588)



(1,866)



(775)

Gain (loss) on foreign currency transactions



(64)



2,650



9,128



680

Total other income (expense), net



(709)



2,062



7,262



(95)














Loss before benefit from income taxes



(3,571)



(2,768)



(3,102)



(13,152)














Benefit from income taxes



401





401
















Net loss


$

(3,170)


$

(2,768)


$

(2,701)


$

(13,152)














Basic and diluted net loss per common share


$

(0.05)


$

(0.05)


$

(0.04)


$

(0.24)














Weighted Average Shares of Common Stock
     Outstanding













Basic and diluted



62,753,959



54,453,006



62,038,902



54,340,583














Other comprehensive income (loss):













Foreign currency translation adjustment, net of
     tax



116



(2,330)



(8,096)



(686)

Comprehensive loss


$

(3,054)


$

(5,098)


$

(10,797)


$

(13,838)


See accompanying notes to condensed consolidated financial statements.

 

CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED)
(in thousands, except share data)











Accumulated














Additional


Other









Common Stock


Paid-In


Comprehensive


Accumulated


Stockholders'



Shares


Par Value


Capital


Income (Loss)


Deficit


Equity

Balance as of June 30, 2025 (unaudited)


62,610,376


$

63


$

319,023


$

(3,960)


$

(303,540)


$

11,586

Stock-based compensation


183,929





488







488

Foreign translation adjustment








116





116

Net loss










(3,170)



(3,170)

Balance at September 30, 2025 (unaudited)


62,794,305


$

63


$

319,511


$

(3,844)


$

(306,710)


$

9,020



















Balance at December 31, 2024


54,830,146


$

55


$

310,809


$

4,252


$

(304,009)


$

11,107

Stock-based compensation


297,160



1



1,878







1,879

Issuance of common stock and warrants from rights
      offerings, net of fees incurred


6,249,791



6



5,386







5,392

Issuance of common stock from exercise of warrants


1,417,208



1



1,438







1,439

Foreign translation adjustment








(8,096)





(8,096)

Net loss










(2,701)



(2,701)

Balance as of September 30, 2025 (unaudited)


62,794,305


$

63


$

319,511


$

(3,844)


$

(306,710)


$

9,020





























Accumulated














Additional


Other









Common Stock


Paid-In


Comprehensive


Accumulated


Stockholders'



Shares


Par Value


Capital


Income


Deficit


Equity

Balance as of June 30, 2024 (unaudited)


54,306,415


$

54


$

308,874


$

2,173


$

(293,674)


$

17,427

Stock-based compensation






891







891

Foreign translation adjustment








(2,330)





(2,330)

ATM activation fees






(41)







(41)

Issuance of restricted stock units


194,198





204







204

Net loss










(2,768)



(2,768)

Balance at September 30, 2024 (unaudited)


54,500,613


$

54


$

309,928


$

(157)


$

(296,442)


$

13,383



















Balance at December 31, 2023


54,240,265


$

54


$

306,187


$

529


$

(283,290)


$

23,480

Stock-based compensation






2,840







2,840

Foreign currency translation adjustment








(686)





(686)

Issuance of common stock offerings, net of fees


53,290





12







12

Warrants issued in connection with long-term debt






691







691

Issuance of restricted stock units


207,058





198







198

Net loss










(13,152)



(13,152)

Balance as of September 30, 2024 (unaudited)


54,500,613


$

54


$

309,928


$

(157)


$

(296,442)


$

13,383


See accompanying notes to condensed consolidated financial statements.

 

CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)



Nine


Nine



Months Ended


Months Ended



September 30, 


September 30, 



2025


2024

Cash flows from operating activities







Net loss


$

(2,701)


$

(13,152)

Adjustments to reconcile net loss to net cash used in operating activities:







Accrued final fee





111

Amortization of debt discount



571



132

Amortization of loan costs





58

Depreciation and amortization



1,137



1,181

Amortization of right-of-use asset



109



138

Write-off of patent cost



176



313

Write-off of inventory



253



Bad debt expense



17



107

Stock-based compensation



1,879



2,840

Foreign currency transaction gains



(9,128)



(680)

Changes in operating assets and liabilities







Accounts receivable



560



(629)

Inventories



(1,247)



153

Prepaid expenses and other current assets



989



505

Other assets





2

Accounts payable and accrued expenses



(167)



(3,166)

Net cash used in operating activities



(7,552)



(12,087)








Cash flows from investing activities







Purchases of property and equipment



(56)



(215)

Payments for patent costs



(68)



(330)

Net cash used in investing activities



(124)



(545)

Cash flows from financing activities







Proceeds from long-term debt





15,000

Repayment of long-term debt





(5,000)

Payment of final fee





(150)

Payment of loan costs





(698)

Equity contributions - net of fees incurred





12

Proceeds from exercise of common stock warrants



1,439



Proceeds from rights offering, net of fees incurred



5,392



Net cash provided by financing activities



6,831



9,164

Effect of exchange rates on cash



139



21

Net change in cash, cash equivalents, and restricted cash



(706)



(3,447)








Cash, cash equivalents, and restricted cash at beginning of year



9,764



15,615

Cash, cash equivalents, and restricted cash – end of period


$

9,058


$

12,168








Supplemental disclosure of cash flow information







Cash paid for interest


$

1,535


$

772








Supplemental disclosure of non-cash financing activities







Warrants issued in connection with long-term debt


$


$

691


See accompanying notes to condensed consolidated financial statements.

 

Reconciliation of GAAP Financial Measures to Non-GAAP Financial Measures



Three Months Ended


Nine Months Ended



September 30, 


September 30, 



2025


2024


2025


2024



(amounts, in thousands)

 Net loss


$

(3,170)


$

(2,768)


$

(2,701)


$

(13,152)

 Depreciation and amortization expense


$

364


$

383


$

1,137


$

1,181

 Income tax benefit


$

(401)


$

-


$

(401)


$

-

 Interest expense, net


$

645


$

588


$

1,866


$

775

 EBITDA – non-GAAP measure


$

(2,562)


$

(1,797)


$

(99)


$

(11,196)














 Non-cash stock-based compensation expense


$

488


$

891


$

1,879


$

2,840

 (Gain)/Loss on foreign currency transactions



64



(2,650)



(9,128)



(680)

 Adjusted EBITDA – non-GAAP measure


$

(2,010)



(3,556)


$

(7,348)


$

(9,036)














 Net loss


$

(3,170)


$

(2,768)


$

(2,701)


$

(13,152)

 Non-cash stock-based compensation expense



488



891



1,879



2,840

 (Gain)/Loss on foreign currency transactions


$

64


$

(2,650)


$

(9,128)


$

(680)

 Adjusted net loss – non-GAAP measure


$

(2,618)


$

(4,527)


$

(9,950)


$

(10,992)

 Weighted average common shares outstanding













 Basic



62,753,959



54,453,006



62,038,902



54,340,583

 Diluted



62,753,959



54,453,006



62,038,902



54,340,583

 Basic net income (loss) per common share


$

(0.05)


$

(0.05)


$

(0.04)


$

(0.24)

 Diluted net income (loss) per common share


$

(0.05)


$

(0.05)


$

(0.04)


$

(0.24)














 Non-cash stock-based compensation expense -
basic


$

0.01


$

0.02


$

0.03


$

0.05

 Non-cash stock-based compensation expense -
diluted


$

0.01


$

0.02


$

0.03


$

0.05

 (Gain)/Loss on foreign currency transactions -
basic


$

-


$

(0.05)


$

(0.15)


$

(0.01)

 (Gain)/Loss on foreign currency transactions -
diluted


$

-


$

(0.05)


$

(0.15)


$

(0.01)

 Adjusted net income (loss) per common share –
basic – non-GAAP measure


$

(0.04)


$

(0.08)


$

(0.16)


$

(0.20)

 Adjusted net income (loss) per common share –
diluted – non-GAAP measure


$

(0.04)


$

(0.08)


$

(0.16)


$

(0.20)

 

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SOURCE Cytosorbents Corp

FAQ

What were CytoSorbents (CTSO) Q3 2025 results and revenue guidance?

CytoSorbents reported Q3 2025 revenue $9.5M (+10% YoY) with no new formal forward revenue guidance disclosed.

When does CTSO expect operating cash-flow breakeven after the November 13, 2025 update?

The company expects to reach operating cash-flow breakeven in Q1 2026 after workforce and cost reductions.

What did the November 13, 2025 credit amendment for CTSO include?

The amendment provides an immediate $2.5M term loan, extends interest-only to Dec 31, 2026, and includes 1,428,571 warrants exercisable at $0.70.

What is the timeline for DrugSorb-ATR regulatory progress (CTSO)?

A pre-submission meeting was requested Nov 7, 2025; the new De Novo filing is planned in Q1 2026 with an anticipated FDA decision by mid-2026.

How much cash did CTSO report on Sept 30, 2025 and what is proforma cash?

Reported cash and equivalents were $9.1M; proforma cash would be $11.6M assuming the additional $2.5M term loan was drawn.

How will the workforce reduction announced Nov 13, 2025 affect CTSO financially?

The company reduced headcount by ~10% and expects a one-time restructuring charge of up to $900k to accelerate breakeven.
Cytosorbents Corp

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Medical Devices
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United States
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