CytoSorbents (NASDAQ: CTSO) details DrugSorb-ATR FDA path and Q1 2026 results
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
CytoSorbents Corporation reported first quarter 2026 revenue of $8.9 million, roughly flat year over year, with 13% growth in direct markets outside Germany and slightly lower sales in Germany on a leaner sales team. Distributor sales were unchanged as delayed orders of about $0.5 million in parts of the Middle East offset progress elsewhere.
Gross margin was 69%, down slightly as the company deliberately reduced production to lower inventory and improve working capital. A late-2025 cost reduction that cut headcount by about 10% helped trim operating expenses, though net loss widened to $5.1 million, or $0.08 per share, versus a $1.5 million loss a year earlier. Adjusted EBITDA improved modestly to a loss of $2.2 million.
The company outlined its U.S. regulatory strategy for the DrugSorb-ATR device. After an FDA appeal maintained a prior denial but raised no safety concerns, CytoSorbents plans a new De Novo application for use with Brilinta, targeting submission in late 2026 or early 2027, and is preparing a separate pre-submission for a potential DOAC indication. Management reiterated its goal of reaching operating cash flow breakeven in the second half of 2026 while navigating temporary geopolitical headwinds and expanding its commercial footprint.
Positive
- None.
Negative
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Insights
Results show stable sales, higher loss, and a clearer but delayed FDA path.
CytoSorbents generated Q1 2026 revenue of $8.9 million, slightly above Q1 2025, with direct sales outside Germany up 13%. Germany held close to prior-year levels despite a smaller team, while distributor revenue was flat as roughly $0.5 million of Middle East orders slipped due to regional instability.
Gross margin was 69%, affected by intentionally lower production to reduce inventories. Operating expenses fell versus last year after a late-2025 workforce reduction of about 10%, yet net loss increased to $5.1 million as foreign currency losses weighed on results. Adjusted EBITDA loss narrowed to $2.2 million, indicating some underlying cost progress.
Regulatory strategy is pivotal. FDA upheld its prior DrugSorb-ATR denial but requested more data without citing safety issues. The company now targets a new De Novo submission for ticagrelor in late 2026 or early 2027 and is pursuing a parallel DOAC pathway. Actual impact will depend on study execution and future FDA decisions.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Revenue: $8.864M
Gross margin: 69%
Net loss: $5.129M
+5 more
8 metrics
Revenue
$8.864M
Three months ended March 31, 2026
Gross margin
69%
First quarter 2026, per management commentary
Net loss
$5.129M
Three months ended March 31, 2026
Adjusted EBITDA
-$2.150M
Non-GAAP, three months ended March 31, 2026
Cash and cash equivalents
$4.813M
As of March 31, 2026
Total assets
$40.562M
As of March 31, 2026
Headcount reduction
10%
Strategic workforce and cost reduction in Q4 2025
Delayed distributor orders
$0.5M
Middle East and neighboring regions, Q1 2026
Key Terms
De Novo application, Breakthrough Device Designation, Adjusted EBITDA, Emergency Use Authorization, +2 more
6 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.
Breakthrough Device Designation regulatory
"It has received two U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designations"
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.
Adjusted EBITDA financial
"Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation"
Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.
Emergency Use Authorization regulatory
"CytoSorb has also received FDA Emergency Use Authorization in the United States"
A regulatory emergency use authorization allows a government health agency to temporarily permit the use or sale of a medical product—such as a vaccine, test, or treatment—before full formal approval when there is a public health crisis. For investors, an authorization can rapidly open revenue and market access while carrying higher regulatory and demand risk, like a fast-track pass that speeds a product to customers but may still require further review and can affect a company's valuation and future sales prospects.
septic shock medical
"a 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.
perioperative bleeding medical
"for reducing the severity of perioperative bleeding in patients undergoing CABG surgery"
Bleeding that occurs during surgery or in the short recovery period afterwards, when blood loss can complicate the operation or healing. It matters to investors because higher rates or severity of this bleeding increase hospital costs, risk of longer stays, additional treatments or legal exposure, and can drive demand for drugs, devices or procedures designed to prevent or control it—similar to how a sudden leak during a renovation raises repair costs and delays completion.
Earnings Snapshot
Revenue: $8.864M · Guidance included
Q1 2026
Revenue
$8.864M
Net loss
$5.129M
Adjusted EBITDA
-$2.150M
Guidance
Management reiterated a goal of achieving operating cash flow breakeven in the second half of 2026.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 13, 2026
(Exact name of registrant as specified in its charter)
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Registrant's telephone number, including area code (973 ) 329-8885
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(Former Name or Former Address, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
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Title of each class
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Name of each exchange on which registered
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act
of 1934 (§240.12b-2 of this chapter):
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 13, 2026, CytoSorbents Corporation issued a press release announcing its financial results for the quarter ended March 31,
2026. A copy of the press release is furnished herewith as Exhibit 99.1.*
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Item 9.01
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Exhibits
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(d) Exhibits
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Description
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99.1
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Press Release of the Company, dated
May 13, 2026
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104
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Cover Page Interactive Data File (embedded with the Inline XBRL document)
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* The information in Items 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific
reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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Dated: May 13, 2026
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CYTOSORBENTS CORPORATION
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By:
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/s/ Dr. Phillip P. Chan
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Name:
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Dr. Phillip P. Chan
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Title:
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Chief Executive Officer
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Exhibit 99.1
CytoSorbents Reports First Quarter 2026 Financial Results, Recent Business Highlights, and Regulatory Update
PRINCETON, N.J., May 13, 2026 — 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
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Revenue was $8.9 million, an increase of 2% over the prior year, from $8.7 million
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Gross margin was 69% in the quarter compared to 71% in Q1 2025
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Operating loss was $3.0 million, compared to $3.9 million in Q1 2025
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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
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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
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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
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Total cash, cash equivalents, and restricted cash was approximately $6.4 million, compared to $7.8 million as of December 31, 2025
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Total cash burn in the quarter, excluding $0.3 million in restructuring-related payments, was approximately $1.1 million
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“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.
Please Click to Follow Us on Facebook and X
U.S. Company Contact:
Peter J. Mariani, Chief Financial Officer
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)
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March 31,
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December 31,
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2026
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2025
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(unaudited)
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ASSETS
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Current Assets:
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Cash and cash equivalents
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$
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4,813
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$
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6,249
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Accounts receivable, net of allowances of $164 as of March 31, 2026 and December 31, 2025
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7,152
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7,550
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Inventories - net
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4,481
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5,281
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Prepaid expenses and other current assets
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1,311
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1,554
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Total current assets
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17,757
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20,634
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Property and equipment - net
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7,510
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7,823
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Restricted cash
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1,522
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1,522
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Right-of-use asset
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10,769
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10,924
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Patents - net
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2,952
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3,226
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Other assets
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52
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53
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Total assets
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$
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40,562
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$
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44,182
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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Current Liabilities:
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Accounts payable
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$
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3,132
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$
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2,869
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Accrued expenses and other current liabilities
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5,960
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6,299
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Lease liability – current portion
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565
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541
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Current maturities of long-term debt, net of debt discount
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6,646
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—
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Total current liabilities
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16,303
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9,709
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Lease liability, net of current portion
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11,752
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11,903
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Long-term debt, net of current portion and debt discount
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10,313
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16,667
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Total liabilities
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38,368
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38,279
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Commitments and Contingencies
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Stockholders’ equity
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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
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—
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—
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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
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63
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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
|
)
|
||
FAQ
How did CytoSorbents (CTSO) perform financially in Q1 2026?
CytoSorbents reported Q1 2026 revenue of $8.9 million, slightly above Q1 2025. Gross margin was 69%, and the company posted a net loss of $5.1 million, or $0.08 per share, reflecting higher foreign currency losses despite lower operating expenses.
What were CytoSorbents’ (CTSO) key cost and margin trends in Q1 2026?
Gross margin declined marginally to 69% as CytoSorbents deliberately reduced production to lower inventory. A late-2025 workforce and cost reduction program, including roughly a 10% headcount cut, reduced operating expenses and contributed to an improved Adjusted EBITDA loss of $2.2 million.
What is the FDA status of CytoSorbents’ DrugSorb-ATR for Brilinta?
The FDA upheld its prior denial of DrugSorb-ATR’s ticagrelor application but raised no safety concerns and requested additional mechanistic and real-world data. CytoSorbents plans a new De Novo submission in late 2026 or early 2027, following further pre-submission interactions.
What are CytoSorbents’ (CTSO) plans for DrugSorb-ATR in DOAC removal?
CytoSorbents plans to submit a separate pre-submission to the FDA within 30 days to review existing data for DOAC removal, including Eliquis and Xarelto. The company aims to determine requirements for a potential parallel De Novo submission targeting this additional indication.
What is the estimated U.S. market opportunity for DrugSorb-ATR?
CytoSorbents estimates the combined U.S. total addressable market for DrugSorb-ATR in cardiac surgery across Brilinta and DOACs at between $500 million and $1 billion annually, reflecting the high number of patients on chronic antithrombotic therapy facing perioperative bleeding risk.
How strong is CytoSorbents’ (CTSO) balance sheet after Q1 2026?
At March 31, 2026, CytoSorbents reported $4.8 million in cash and cash equivalents, $6.3 million including restricted cash, and total assets of $40.6 million. Total liabilities were $38.4 million, leaving stockholders’ equity of approximately $2.2 million.