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CytoSorbents Reports First Quarter 2026 Financial Results, Recent Business Highlights, and Regulatory Update

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CytoSorbents (NASDAQ: CTSO) reported Q1 2026 revenue of $8.9 million, up 2% year-over-year, with a 69% gross margin. Operating loss improved to $3.0 million, while net loss increased to $5.1 million, mainly from non-cash foreign currency effects. Cash stood at $6.4 million, with approximately $1.1 million quarterly cash burn excluding restructuring.

The company cited 13% growth in direct sales territories outside Germany, benefits from a 10% prior headcount reduction, and continued progress toward operating cash flow breakeven in 2H 2026. It is preparing a new De Novo submission for DrugSorb-ATR for Brilinta, targeting late 2026 or early 2027, and assessing a parallel De Novo path for DOAC removal. New clinical and health-economic data support safety, bleeding reduction in CABG subpopulations, and cost-effectiveness in septic shock.

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AI-generated analysis. How Rhea-AI works. Not financial advice.

Positive

  • Q1 2026 revenue increased 2% year-over-year to $8.9 million
  • Operating loss narrowed to $3.0 million from $3.9 million in Q1 2025
  • Adjusted net loss improved to $3.4 million from $3.7 million year-over-year
  • Adjusted EBITDA loss improved to $2.2 million from $2.7 million in Q1 2025
  • Quarterly cash burn about $1.1 million excluding $0.3 million restructuring payments
  • Direct sales territories outside Germany grew approximately 13% year-over-year
  • Germany sales were slightly below prior year with a smaller, more focused team
  • Headcount cut of about 10% in late 2025 reduced operating and production expenses
  • Company reiterates goal of operating cash flow breakeven in the second half of 2026
  • FDA provided clearer direction for a new DrugSorb-ATR De Novo submission for Brilinta
  • Targeted timing for new Brilinta De Novo filing is late 2026 or early 2027
  • Planned FDA pre-submission within 30 days for DrugSorb-ATR DOAC indication
  • Estimated U.S. cardiac surgery TAM for DrugSorb-ATR between $500 million and $1 billion annually
  • STAR-T trial publication reports intraoperative DrugSorb-ATR use is safe within 2 days of ticagrelor discontinuation
  • STAR-T CABG subpopulation showed reduced severe bleeding events with DrugSorb-ATR use
  • Swiss septic shock study found CytoSorb therapy reduced ICU and hospital length of stay
  • Septic shock analysis showed higher net case profitability versus standard of care alone

Negative

  • Gross margin declined to 69% from 71% in Q1 2025
  • Net loss increased to $5.1 million from $1.5 million year-over-year
  • Cash, cash equivalents, and restricted cash fell to $6.4 million from $7.8 million at year-end 2025
  • Distributor sales were flat year-over-year in Q1 2026
  • Approximately $500,000 in distributor orders were delayed in parts of the Middle East and neighboring regions
  • Geopolitical and economic instability related to the U.S.-Iran war disrupted growth of the Dubai subsidiary
  • FDA requested additional mechanistic data for the new DrugSorb-ATR Brilinta De Novo submission
  • New De Novo submission timing for Brilinta is later than previously expected

News Market Reaction – CTSO

-5.05% 1.6x vol
4 alerts
-5.05% News Effect
+2.6% Peak Tracked
-15.6% Trough Tracked
-$2M Valuation Impact
$38.31M Market Cap
1.6x Rel. Volume

On the day this news was published, CTSO declined 5.05%, reflecting a notable negative market reaction. Argus tracked a peak move of +2.6% during that session. Argus tracked a trough of -15.6% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $38.31M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

What This Means

The stock moved -5.0% in the session following this news. The decline reflects concern over the larg...
Analysis

The stock moved -5.0% in the session following this news. The decline reflects concern over the larger reported net loss of $5.1M (or $0.08 per share) and cash of $6.4M despite modest revenue growth. This fits a pattern where earnings updates have sometimes triggered downside moves, including a -10.61% reaction to 2025 results. Ongoing Nasdaq minimum bid price risk and dependence on future DrugSorb‑ATR approvals add to uncertainty despite improving adjusted EBITDA trends.

Key Figures

Q1 2026 revenue: $8.9M Gross margin: 69% Operating loss: $3.0M +5 more
8 metrics
Q1 2026 revenue $8.9M Quarter ended March 31, 2026; up from $8.7M in prior-year Q1
Gross margin 69% Q1 2026 vs 71% in Q1 2025
Operating loss $3.0M Q1 2026 vs $3.9M in Q1 2025
Net loss per share $0.08 Q1 2026 vs $0.02 in Q1 2025; higher due to FX impacts
Adjusted EBITDA loss $2.2M Q1 2026 vs $2.7M in Q1 2025
Cash & equivalents $6.4M As of March 31, 2026; down from $7.8M at Dec 31, 2025
Quarterly cash burn $1.1M Q1 2026 burn excluding $0.3M restructuring payments
U.S. TAM DrugSorb-ATR $500M–$1B annually Estimated total addressable market for cardiac surgery across Brilinta and DOACs

Previous Earnings Reports

5 past events · Latest: Mar 25 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 25 Full-year 2025 earnings Positive -10.6% Revenue growth to $37.1M and sharply reduced annual net loss in 2025.
Nov 13 Q3 2025 earnings Positive -0.8% Q3 2025 revenue up 10% to $9.5M with improved operating loss and restructuring.
Aug 07 Q2 2025 earnings Positive +12.0% Q2 2025 revenue up 9% to $9.6M and swing to $1.9M net income.
May 14 Q1 2025 earnings Mixed +3.3% Q1 2025 product revenue down 3% but significantly improved net loss and cash raise.
Mar 31 Full-year 2024 earnings Positive +0.0% Strong Q4 2024 and 15% full-year product revenue growth with 71% margins.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings releases have produced mixed reactions, including both double-digit gains and losses, with a slight positive average but frequent downside moves on recent reports.

Recent Company History

Over the past year, CytoSorbents’ earnings updates have highlighted modest revenue growth and ongoing efforts to narrow losses. Prior quarters showed revenue rising to $37.1M in 2025 with 71%–72% gross margins and improving operating losses, alongside cost-cutting and credit facility support. Earlier quarters featured double-digit revenue growth and periods of net profitability. Today’s Q1 2026 report, with $8.9M revenue, slightly lower gross margin, and a larger reported net loss, continues the theme of incremental commercial progress offset by profitability and cash runway pressures.

Historical Comparison

+0.8% avg move · In the last five earnings reports, CTSO’s average move was about 0.77%, with both sharp gains and lo...
earnings
+0.8%
Average Historical Move earnings

In the last five earnings reports, CTSO’s average move was about 0.77%, with both sharp gains and losses. Today’s -7% reaction skews more negative than the typical earnings-day response.

Earnings releases show a shift from strong double-digit revenue growth and occasional profitability in 2024–Q2 2025 toward modest 2025 growth, cost-cutting, and a focus on reaching cash flow breakeven while advancing DrugSorb‑ATR regulatory plans.

Regulatory & Risk Context

Short Interest: 4.38%
Short Interest
4.38% of float
0% 15% 30%+
low as of 2026-05-29 Days to cover: 18.52

Key Terms

de novo application, mdufa, breakthrough device designation, direct oral anticoagulants, +4 more
8 terms
de novo application regulatory
"we announced our intention to submit a new De Novo application incorporating additional supporting information"
A de novo application is a regulatory request to classify and clear a novel medical device that has no previously approved equivalent, asking the regulator to recognize it as low-to-moderate risk and allow it to be marketed. For investors, success means a company can sell a new product without proving it’s identical to an existing one, which opens a market opportunity and reduces uncertainty—like getting official permission to sell a new type of key when no matching key exists.
mdufa regulatory
"within the FDA's targeted 150-day MDUFA review timeline"
MDUFA stands for Medical Device User Fee Amendments, a U.S. program where manufacturers pay fees to fund the Food and Drug Administration’s review of medical devices. Think of it like a service fee that helps the regulator hire staff and run faster, more predictable reviews; for investors, changes in MDUFA levels or terms can affect approval timelines, regulatory certainty and the cost of bringing new devices to market.
breakthrough device designation regulatory
"aligned with our other FDA Breakthrough Device Designation for DrugSorb-ATR, to remove DOACs"
A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.
direct oral anticoagulants medical
"expanded indication for the removal of direct oral anticoagulants (DOACs), such as Eliquis"
Direct oral anticoagulants are prescription drugs taken by mouth that reduce the blood’s ability to form clots, used to prevent strokes and dangerous clots in conditions like irregular heartbeat or after certain surgeries. For investors, they matter because approval, safety data, patent protection, and competitive pricing directly affect sales and liability risk—similar to how a new, safer brake design can reshape demand and market share in the auto industry.
cabg medical
"perioperative bleeding in patients undergoing CABG surgery while on Brilinta"
Coronary artery bypass grafting (CABG) is an open-heart surgery that creates new pathways around blocked heart arteries using blood vessels taken from elsewhere in the body, restoring blood flow to the heart muscle. For investors, CABG signals demand for cardiac hospitals, surgical devices, graft materials and postoperative care; its prevalence and outcomes can affect revenues, costs and regulatory scrutiny across medical device makers, hospitals and healthcare insurers.
hemoadsorption medical
"Impact of CytoSorb Hemoadsorption Therapy on Cost-Effectiveness and Length of Stay"
Hemoadsorption is a medical blood‑cleaning technique that passes a patient’s blood through a device or cartridge that acts like a sponge to remove unwanted substances such as toxins, excess inflammatory molecules, or drug residues. Investors care because these devices represent a clinical treatment platform whose commercial success depends on demonstrated patient benefit, regulatory approvals, hospital adoption and reimbursement, all of which affect sales potential and valuation in the medical device market.
septic shock medical
"comparative analysis of 246 ICU patients with septic shock"
Septic shock is a life-threatening condition caused by a severe bodily response to infection that leads to dangerously low blood pressure and failing organs. Think of it like a city’s emergency systems collapsing after a major storm: hospitals need intensive care, special drugs and equipment, and longer stays. For investors, its incidence and treatment options matter because they affect demand for drugs, medical devices, hospital resources, trial outcomes, regulatory attention and potential liability costs.
pre-submission meeting regulatory
"we held a formal pre-submission meeting with the FDA in late January 2026"
A pre-submission meeting is a planned discussion between a company and a regulatory agency to review plans and data before the company formally files for product approval. It matters to investors because the meeting can reveal what additional tests or information regulators will require, helping reduce surprise delays or costs—think of it like showing a building inspector your blueprints before applying for a construction permit to catch problems early.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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PRINCETON, N.J., May 13, 2026 /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 first quarter ended March 31, 2026, recent business highlights, and provides a regulatory update. 

First Quarter 2026 Financial Results

  • Revenue was $8.9 million, an increase of 2% over the prior year, from $8.7 million
  • Gross margin was 69% in the quarter compared to 71% in Q1 2025
  • Operating loss was $3.0 million, compared to $3.9 million in Q1 2025  
  • Net loss was $5.1 million or $0.08 per share, compared to a net loss of $1.5 million or $0.02 per share in Q1 2025.  The increase was due primarily to the non-cash impact of changes in foreign currency transactions year-over-year  
  • Adjusted net loss, which excludes the impact of non-cash changes in foreign currency transactions and non-cash stock compensation, was $3.4 million or $0.05 per share, compared to an adjusted net loss of $3.7 million or $0.06 per share in Q1 2025
  • Adjusted EBITDA loss, which also excludes the impact of non-cash changes in foreign currency transactions and non-cash stock compensation was $2.2 million compared to a loss of $2.7 million in Q1 2025
  • Total cash, cash equivalents, and restricted cash was approximately $6.4 million, compared to $7.8 million as of December 31, 2025  
  • Total cash burn in the quarter, excluding $0.3 million in restructuring-related payments, was approximately $1.1 million  

"First quarter sales were $8.9 million, driven by 13% growth in our direct sales territories outside of Germany," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents Corporation.  "Our Germany sales team also performed well, achieving sales slightly below last year, but with a smaller and more focused team – reflecting new leadership, sales execution, account targeting, productivity, and customer engagement.  Given the importance of the German market, we plan to selectively expand our commercial team to improve account coverage and drive growth opportunities in both critical care and cardiac surgery.

Distributor sales were flat year-over-year, as progress across several territories was offset by delayed distributor orders of approximately $500,000 in parts of the Middle East and neighboring regions due to geopolitical and economic instability related to the U.S.-Iran war.  This unexpected disruption has slowed the anticipated growth of our recently established subsidiary in Dubai, UAE, although we expect conditions to improve as the conflict stabilizes.

Gross margin declined marginally to 69% in the first quarter, primarily due to intentionally reduced production volumes aimed at lowering inventory levels and improving working capital.  

In the fourth quarter of 2025, we implemented a strategic workforce and cost reduction initiative, reducing headcount by approximately 10% while lowering operating and production expenses.  The initial benefits of this program were reflected in lower expenses and improved operating margins in the first quarter.  Meanwhile, we have continued to make operational improvements and cost reductions and believe these actions will continue to drive improvements in the coming quarters to support our goal of achieving operating cash flow breakeven in the second half of this year."  

DrugSorb-ATR® for Brilinta®

"In August 2025, we received the FDA's decision on our appeal of the original DrugSorb-ATR application.  Importantly, the Agency identified no concerns regarding device safety but upheld the prior denial of the application and requested additional information to support the proposed indication for reducing the severity of perioperative bleeding in patients undergoing CABG surgery while on Brilinta® (ticagrelor, AstraZeneca).

Following the appeal decision and based on feedback from FDA, we announced our intention to submit a new De Novo application incorporating additional supporting information, primarily based on real-world evidence and clinical outcomes generated through routine clinical use of the device.  As part of this process, we held a formal pre-submission meeting with the FDA in late January 2026 and have continued to engage with the Agency to clarify the requirements for the new De Novo submission, including whether all information would be required within the submission or as a post-marketing requirement. Based on these interactions, the FDA has requested additional mechanistic data to be included alongside the real-world evidence within the new De Novo submission.

We are currently evaluating options to generate the additional mechanistic data on an expedited basis and expect to schedule an additional pre-submission meeting with the FDA, if needed, to discuss and align on the proposed approach.  Once alignment is achieved, we anticipate completing the required work and submitting a new De Novo application in late 2026 or early 2027.  Though delayed from our timeline, we now have clearer direction and are committed to obtaining the new information and filing a new De Novo submission as soon as possible.  Following submission, a regulatory decision would generally be expected within the FDA's targeted 150-day MDUFA review timeline, although the actual review period may be shorter or longer depending on the nature and extent of interactive review questions from the Agency.

Meanwhile, the U.S. and Canadian pivotal STAR-T randomized, controlled trial results are now available in PDF form from the Journal of Thoracic and Cardiovascular Surgery (2026) - the leading peer-reviewed cardiothoracic surgery journal in the U.S., highlighting "Intraoperative use of DrugSorb-ATR is safe in patients operated within 2 days of ticagrelor discontinuation [with] significant reductions in severe bleeding events in the prespecified CABG subpopulation"

DrugSorb-ATR for DOACs: Eliquis® and Xarelto®

"We have previously discussed our intention, following anticipated FDA marketing approval of DrugSorb-ATR for Brilinta®, to pursue an expanded indication for the removal of direct oral anticoagulants (DOACs), such as Eliquis® (apixaban, Pfizer/BMS) and Xarelto® (rivaroxaban, Bayer/Janssen).  At the same time, we continue to observe increasing real-world adoption, clinical use, and published evidence supporting the use of our technology for DOAC removal in cardiac surgery, reinforcing the significant unmet medical need globally. 

Within the next 30 days, we plan to submit a separate pre-submission request to the Agency to review the data currently available for the DOAC indication that include drug removal data from benchtop testing and data from real-world use and to determine what, if any, additional information may be required to support a parallel De Novo submission for DOAC removal. 

Having this potential second shot on goal is aligned with our other FDA Breakthrough Device Designation for DrugSorb-ATR, to remove DOACs during cardiac surgery.  Globally, tens of millions of patients are on chronic or life-long DOAC therapy due to atrial fibrillation, deep vein thrombosis, pulmonary embolism, peripheral vascular disease, or post-surgical prophylaxis.  An estimated 5-10% of emergent cardiac surgery cases involve patients who are currently therapeutic on a DOAC and risk serious or life-threatening perioperative bleeding. 

In 2025, Eliquis ranked #7 among the top-selling pharmaceuticals globally, generating approximately $14.4 billion in worldwide sales and accounting for a majority share of new oral anticoagulant prescriptions.  Xarelto generated approximately $5.1 billion in global sales. We estimate that the combined U.S. total addressable market for DrugSorb-ATR in cardiac surgery across Brilinta® and the DOACs is between $500 million and $1 billion annually."

New Health Economic Analysis in Septic Shock

"Finally, in our last earnings call update, we highlighted many key publications across critical care and cardiac surgery.  Recently, an important study entitled 'Impact of CytoSorb Hemoadsorption Therapy on Cost-Effectiveness and Length of Stay in Critical Care Patients: A Preliminary Study from a Swiss High-Volume Center", was published in the peer-reviewed journal Healthcare.  This study provides compelling real-world evidence for the cost-effectiveness of CytoSorb hemoadsorption in a comparative analysis of 246 ICU patients with septic shock.  Compared to patients treated with standard of care alone, those additionally treated with CytoSorb showed significant reductions in ICU and hospital length of stay, duration of mechanical ventilation among survivors, and nursing workload, while total hospital treatment costs were not significantly increased.  CytoSorb therapy showed a clear advantage in net case profitability (revenue minus costs), with significantly higher earnings per case compared to standard of care.  These results highlight the cost-effectiveness of CytoSorb therapy and the ability to achieve clinical, operational, and economic benefits in a resource-intensive critical care setting."

Dr. Chan concluded, "While we continue to navigate what we believe to be temporary headwinds in the Middle East, we remain focused on executing on our key priorities including:  strengthening commercial performance, reducing operating expenses, and progressing toward our goal of achieving operating cash flow breakeven in the second half of this year.  At the same time, we are advancing the substantial long-term U.S. opportunity for DrugSorb-ATR.  We now have clearer regulatory direction from the FDA for our ticagrelor application and are actively evaluating a potential parallel path focused on DOACs that could significantly expand the U.S. market opportunity.  We believe the actions we are taking today are building a stronger, more resilient company and positioning us to deliver meaningful long-term value for patients, clinicians, and shareholders."  

First Quarter 2026 Earnings Conference Call

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

Date: Wednesday May 13, 2026
Time: 4:30 PM ET
Live webcast link: https://app.webinar.net/KbgRLmJk8ow

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 DrugSorb-ATR

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 U.S. Food and Drug Administration ("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.

The Company continues to actively pursue regulatory approval of DrugSorb-ATR with the FDA and expects to pursue regulatory approval in Canada with better visibility from the FDA. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

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 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 more than 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, PuriFi®, HotSwap®, and others. For more information, please visit the Company's website at https://ir.cytosorbents.com/  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, the impact of geopolitical events including the recent war in Iran, our ability to successfully obtain U.S. FDA and Health Canada regulatory approval and marketing authorization, our ability to complete our strategic workforce and cost reduction plan to reduce costs, optimize operations, and achieve operating cash-flow break-even in the second half of 2026, our ability to appropriately finance the Company, including our ability to meet our financial obligations and comply with the covenants under our existing debt agreement, and the risks discussed in our Annual Report on Form 10-K, to be filed with the SEC by March 30, 2026, 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
ir@cytosorbents.com

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)










March 31, 


December 31, 



2026


2025



(unaudited)



ASSETS







Current Assets:







Cash and cash equivalents


$

4,813


$

6,249

Accounts receivable, net of allowances of $164 as of March 31, 2026 and
December 31, 2025



7,152



7,550

Inventories - net



4,481



5,281

Prepaid expenses and other current assets



1,311



1,554

Total current assets



17,757



20,634








Property and equipment - net



7,510



7,823

Restricted cash



1,522



1,522

Right-of-use asset



10,769



10,924

Patents - net



2,952



3,226

Other assets



52



53

Total assets


$

40,562


$

44,182








LIABILITIES AND STOCKHOLDERS' EQUITY







Current Liabilities:







Accounts payable


$

3,132


$

2,869

Accrued expenses and other current liabilities



5,960



6,299

Lease liability – current portion



565



541

Current maturities of long-term debt, net of debt discount



6,646



Total current liabilities



16,303



9,709

Lease liability, net of current portion



11,752



11,903

Long-term debt, net of current portion and debt discount



10,313



16,667

Total liabilities



38,368



38,279








Commitments and Contingencies














Stockholders' equity







Preferred Stock, par value $0.001, 5,000,000 shares authorized; no shares
issued and outstanding as of March 31, 2026 and December 31, 2025





Common Stock, par value $0.001, 100,000,000 shares authorized as of
March 31, 2026 and December 31, 2025; 62,733,305 and 62,804,305
shares issued and outstanding as of March 31, 2026 and
December 31, 2025 respectively



63



63

Additional paid-in capital



321,568



321,024

Accumulated other comprehensive loss



(2,101)



(2,977)

Accumulated deficit



(317,336)



(312,207)

Total stockholders' equity



2,194



5,903

Total liabilities and stockholders' equity


$

40,562


$

44,182


CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

(in thousands, except share and per share data)










Three Months Ended March 31, 



2026


2025

Revenue, net


$

8,864


$

8,727

Cost of goods sold



2,734



2,520

Gross profit



6,130



6,207








Operating expenses







Research and development, net of grant income



1,025



1,663

Selling, general and administrative



8,149



8,432

Total operating expenses



9,174



10,095

Loss from operations



(3,044)



(3,888)








Other income (expense)







Interest expense, net



(857)



(605)

Gain (loss) on foreign currency transactions



(1,228)



3,014

Total other income (expense), net



(2,085)



2,409








Net loss


$

(5,129)


$

(1,479)








Basic and diluted net loss per common share


$

(0.08)


$

(0.02)








Weighted Average Shares of Common Stock Outstanding







Basic and diluted



62,738,827



60,731,929








Other comprehensive income (loss):







Foreign currency translation adjustment, net of tax



876



(2,736)

Comprehensive loss


$

(4,253)


$

(4,215)


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 at December 31, 2025


62,804,305


$

63


$

321,024


$

(2,977)


$

(312,207)


$

5,903

Stock-based compensation






544







544

Reversal of excess RSU shares issued


(71,000)











Foreign currency translation adjustment, net of tax








876





876

Net loss










(5,129)



(5,129)

Balance at March 31, 2026 


62,733,305


$

63


$

321,568


$

(2,101)


$

(317,336)


$

2,194





























Accumulated














Additional


Other









Common Stock


Paid-In


Comprehensive


Accumulated


Stockholders'



Shares


Par Value


Capital


Income


Deficit


Equity

Balance at December 31, 2024


54,830,146


$

55


$

310,809


$

4,252


$

(304,009)


$

11,107

Stock-based compensation


32,321





818







818

Issuance of common stock from exercise of warrants


1,417,208



2



1,437







1,439

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


6,249,791



6



5,386







5,392

Foreign currency translation adjustment, net of tax








(2,736)





(2,736)

Net loss










(1,479)



(1,479)

Balance at March 31, 2025


62,529,466


$

63


$

318,450


$

1,516


$

(305,488)


$

14,541




















CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(in thousands)










Three


Three



Months Ended


Months Ended



March 31, 


March 31, 



2026


2025

Cash flows from operating activities







Net loss


$

(5,129)


$

(1,479)

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







Amortization of debt discount



291



190

Amortization of patents



61



63

Depreciation



289



306

Amortization of right-of-use asset



26



36

Loss on abandoned patents



274



8

Bad debt expense (recovery)



(1)



2

Stock-based compensation



544



818

Foreign currency transaction (gains) losses



1,228



(3,014)

Changes in operating assets and liabilities







Accounts receivable



310



(80)

Inventories



723



(199)

Prepaid expenses and other current assets



129



250

Other assets



1



Accounts payable and accrued expenses



92



(367)

Net cash used in operating activities



(1,162)



(3,466)








Cash flows from investing activities







Purchases of property and equipment



(11)



(2)

Disposals of property and equipment



26



Payments for patent costs



(61)



(45)

Net cash used in investing activities



(46)



(47)

Cash flows from financing activities







Cash for exercise of warrants, net





1,439

Proceeds from rights offering, net





5,392

Net cash provided by financing activities





6,831

Effect of exchange rates on cash



(228)



28

Net change in cash, cash equivalents, and restricted cash



(1,436)



3,346








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



7,771



9,764

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


$

6,335


$

13,110








Supplemental disclosure of cash flow information







Cash paid for interest


$

591


$

506








Supplemental disclosure of non-cash financing activities







Fair value of common stock warrants issued in connection with the rights offering





556

Offering fees included in accounts payable


$


$

253


RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES




Three Months Ended



March 31,



2026


2025



(amounts, in thousands)

Net income (loss)


$

(5,129)


$

(1,479)

Depreciation and amortization expense


$

350


$

369

Income tax expense (benefit)


$

-


$

-

Interest expense (income)


$

857


$

605

EBITDA – non-GAAP measure


$

(3,922)


$

(505)








Non-cash stock-based compensation expense


$

544


$

818

(Gain)/Loss on foreign currency transactions



1,228



(3,014)

Adjusted EBITDA – non-GAAP measure


$

(2,150)


$

(2,701)








Net income (loss)


$

(5,129)


$

(1,479)

Non-cash stock-based compensation expense



544



818

(Gain)/Loss on foreign currency transactions


$

1,228


$

(3,014)

Adjusted net loss – non-GAAP measure


$

(3,357)


$

(3,675)

Weighted average common shares outstanding







Basic



62,738,827



60,731,929

Diluted



62,738,827



60,731,929

Basic net income (loss) per common share


$

(0.08)


$

(0.02)

Diluted net income (loss) per common share


$

(0.08)


$

(0.02)








Non-cash stock-based compensation expense - basic


$

0.01


$

0.01

Non-cash stock-based compensation expense - diluted


$

0.01


$

0.01

(Gain)/Loss on foreign currency transactions - basic


$

0.02


$

(0.05)

(Gain)/Loss on foreign currency transactions - diluted


$

0.02


$

(0.05)

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


$

(0.05)


$

(0.06)

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


$

(0.05)


$

(0.06)

 

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SOURCE Cytosorbents Corp

FAQ

How did CytoSorbents (NASDAQ: CTSO) perform financially in Q1 2026?

CytoSorbents reported Q1 2026 revenue of $8.9 million, up 2% year-over-year. According to the company, gross margin was 69%, operating loss narrowed to $3.0 million, but net loss rose to $5.1 million, mainly due to non-cash foreign currency transaction impacts.

What were CytoSorbents' Q1 2026 losses and adjusted EBITDA (CTSO)?

In Q1 2026, CytoSorbents reported a net loss of $5.1 million, or $0.08 per share. According to the company, adjusted net loss was $3.4 million and adjusted EBITDA loss was $2.2 million, both improved from Q1 2025 after excluding non-cash items.

What regulatory update did CytoSorbents provide on DrugSorb-ATR for Brilinta in May 2026?

CytoSorbents plans a new De Novo submission for DrugSorb-ATR’s Brilinta indication in late 2026 or early 2027. According to the company, FDA requested additional mechanistic data alongside real-world evidence, and a recent pre-submission meeting clarified requirements and next steps.

What is CytoSorbents' plan for DrugSorb-ATR in DOAC removal, including Eliquis and Xarelto?

CytoSorbents intends to pursue an expanded DrugSorb-ATR indication for DOAC removal in cardiac surgery. Within 30 days, it plans an FDA pre-submission to review existing benchtop and real-world data and assess requirements for a potential parallel De Novo submission for Eliquis and Xarelto.

What clinical and economic data support CytoSorbents’ products as of Q1 2026?

Published STAR-T trial results report DrugSorb-ATR as safe and reducing severe bleeding in a CABG subpopulation. According to CytoSorbents, a Swiss septic shock study showed reduced ICU stay, ventilation duration, and higher net case profitability versus standard care when using CytoSorb hemoadsorption.

What was CytoSorbents' cash position and cash burn in Q1 2026 (CTSO)?

CytoSorbents ended Q1 2026 with about $6.4 million in cash, cash equivalents, and restricted cash. According to the company, total quarterly cash burn was roughly $1.1 million excluding $0.3 million in restructuring-related payments, reflecting ongoing cost control efforts and prior headcount reductions.

When is the CytoSorbents Q1 2026 earnings conference call and webcast?

CytoSorbents scheduled its Q1 2026 earnings conference call for Wednesday, May 13, 2026, at 4:30 PM ET. According to the company, investors can access a live webcast and later an archived recording via the investor relations section of its website.