Cytosorbents Narrows 9-Month Loss to $2.7M on Revenue Growth

TL;DR

**Cytosorbents is burning cash and facing a going concern, making it a risky bet despite improved nine-month losses driven by one-time gains.**

AI Summary

Cytosorbents Corp (CTSO) reported a net loss of $3.17 million for the three months ended September 30, 2025, a slight increase from the $2.77 million net loss in the prior-year period. However, the net loss for the nine months ended September 30, 2025, significantly improved to $2.70 million from $13.15 million in the same period of 2024. Revenue increased to $9.49 million for the three months ended September 30, 2025, up from $8.61 million in 2024, and for the nine months, revenue grew to $27.83 million from $26.44 million. Gross profit also saw an increase, reaching $6.67 million for the quarter and $19.69 million for the nine months. Operating expenses decreased, with research and development, net of grant income, falling to $0.92 million for the quarter from $1.83 million in 2024. The company's cash and cash equivalents stood at $7.54 million as of September 30, 2025, with total assets at $45.75 million. A significant foreign currency transaction gain of $9.13 million for the nine months ended September 30, 2025, positively impacted the net loss. The company also received a $1.7 million benefit from the New Jersey Technology Business Tax Certificate Program in April 2025.

Why It Matters

This filing reveals a mixed financial picture for Cytosorbents, with a quarterly net loss widening but a substantial improvement in the nine-month net loss, primarily driven by foreign currency gains and reduced R&D. For investors, the going concern warning is critical, indicating potential future dilution or operational cutbacks if additional capital isn't secured. The delay in DrugSorb-ATR's U.S. regulatory decision to mid-2026 impacts future revenue streams and competitive positioning against other blood purification technologies. Employees face uncertainty given the 'Strategic Workforce and Cost Reduction Plan' mentioned in subsequent events, while customers might see impacts on product availability or new product launches if funding issues persist. The broader market for medical devices, particularly in blood purification, will watch how Cytosorbents navigates these challenges, especially with its reliance on the European market for CytoSorb sales.

Risk Assessment

Risk Level: high — The company explicitly states that its cash balances of approximately $9.1 million as of September 30, 2025, combined with historical cash used in operations, "raises substantial doubt about the Company's ability to continue as a going concern within twelve months." This is a direct and severe warning from management, indicating significant financial instability and potential inability to meet obligations without further funding.

Analyst Insight

Investors should exercise extreme caution and consider this a high-risk investment. Given the explicit going concern warning and the need for additional capital, potential investors should wait for clear evidence of successful financing and a sustainable path to profitability before considering a position. Existing investors should evaluate their risk tolerance and the potential for significant dilution or operational restructuring.

Financial Highlights

debt To Equity

4.07

revenue

$27.83M

operating Margin

-37.2%

total Assets

$45.75M

total Debt

$26.62M

net Income

-$2.70M

eps

N/A

gross Margin

70.7%

cash Position

$7.54M

revenue Growth

+5.2%

Revenue Breakdown

Key Numbers

• $2.70M — Net Loss (9 months ended Sep 30, 2025) (Significantly improved from $13.15M in 2024, largely due to foreign currency gains.)
• $3.17M — Net Loss (3 months ended Sep 30, 2025) (Increased from $2.77M in the prior-year quarter.)
• $27.83M — Revenue (9 months ended Sep 30, 2025) (Increased from $26.44M in the prior-year period.)
• $9.49M — Revenue (3 months ended Sep 30, 2025) (Increased from $8.61M in the prior-year quarter.)
• $9.1M — Cash, cash equivalents, and restricted cash (as of Sep 30, 2025) (Raises substantial doubt about the company's ability to continue as a going concern.)
• $9.13M — Foreign currency transaction gains (9 months ended Sep 30, 2025) (Major contributor to the reduced net loss, up from $0.68M in 2024.)
• $1.7M — Benefit from New Jersey Technology Business Tax Certificate Program (Received in April 2025 from the sale of 2023 and amended 2022 net operating losses and R&D credits.)
• 62,804,305 — Shares of Common Stock Outstanding (as of Nov 10, 2025) (Increased from 54,830,146 shares as of December 31, 2024, indicating dilution.)

Key Players & Entities

• Cytosorbents Corp (company) — registrant
• CytoSorbents Medical, Inc. (company) — wholly owned subsidiary
• CytoSorbents Europe GmbH (company) — wholly owned European subsidiary
• DrugSorb-ATR (product) — potential new product awaiting U.S. regulatory approval
• New Jersey Technology Business Tax Certificate Program (regulator) — source of tax benefit
• Avenue Capital Commitment (company) — potential source of Tranche 2(b) funding
• FDIC (regulator) — Federal Deposit Insurance Corporation
• IntraFi Network (company) — cash management service provider

FAQ

Risk Factors

• Going Concern Uncertainty [high — financial]: As of September 30, 2025, the company had cash and cash equivalents of $7.54 million. While this is an increase from prior periods, the company has consistently reported net losses. The significant improvement in net loss for the nine months was heavily influenced by a $9.13 million foreign currency gain, which may not be recurring.
• Dilution from Stock Issuance [medium — financial]: The number of outstanding common shares increased from 54,830,146 as of December 31, 2024, to 62,804,305 as of November 10, 2025. This represents a significant dilution of approximately 14.5% in less than a year, which can negatively impact existing shareholders.
• Dependence on Non-Recurring Gains [high — operational]: The substantial reduction in net loss for the nine-month period ($2.70M in 2025 vs. $13.15M in 2024) was primarily driven by a $9.13 million foreign currency transaction gain. This gain is not a core operational result and its absence in future periods could lead to a return to larger net losses.
• Increased Quarterly Net Loss [medium — operational]: Despite revenue growth, the net loss for the three months ended September 30, 2025, increased to $3.17 million from $2.77 million in the prior-year period. This indicates potential challenges in controlling operating expenses or managing costs relative to revenue in the short term.
• High Operating Expenses [medium — financial]: Total operating expenses for the nine months ended September 30, 2025, were $30.05 million, a decrease from $31.69 million in the prior year, but still substantial relative to revenue. Selling, general, and administrative expenses alone were $26.21 million for the nine-month period.

Industry Context

Cytosorbents operates in the critical care medical device market, focusing on extracorporeal cytokine and toxin removal. The industry is characterized by high R&D investment, stringent regulatory approvals (FDA, EMA), and a competitive landscape with established players and emerging technologies. Growth is driven by increasing demand for advanced therapies in sepsis, organ support, and inflammatory conditions.

Regulatory Implications

As a medical device company, Cytosorbents is subject to rigorous regulatory oversight from bodies like the FDA and EMA. Compliance with manufacturing standards (e.g., ISO 13485), product approvals, and post-market surveillance are critical. Any failure to meet these standards could result in product recalls, fines, or market access restrictions.

What Investors Should Do

1. Monitor recurring revenue and profitability drivers.
2. Evaluate the impact of share dilution.
3. Assess cash burn rate and runway.
4. Scrutinize R&D and SG&A spending.

Key Dates

• 2025-09-30: End of Q3 2025 — Reporting period for the 10-Q, showing improved nine-month net loss but increased quarterly net loss, with $7.54M in cash.
• 2025-04-01: Receipt of NJ Technology Business Tax Certificate Program Benefit — Provided a $1.7 million benefit, positively impacting the financial results for the nine-month period.
• 2025-11-10: Shares Outstanding Date — Reported 62,804,305 shares outstanding, indicating significant dilution from the end of 2024.

Glossary

Accumulated deficit

The total net losses of a company since its inception that have not been offset by net income. (Indicates the company has historically operated at a loss, with a deficit of $306.71 million as of September 30, 2025.)

Foreign currency transaction gain (loss)

The profit or loss resulting from changes in exchange rates between the time a transaction is initiated and when it is settled. (A significant $9.13 million gain in this category for the nine months ended September 30, 2025, was a major factor in reducing the reported net loss.)

Right-of-use asset

An asset representing a lessee's right to use an underlying asset for the lease term under a lease agreement. (Represents a significant portion of the company's non-current assets, valued at $11.075 million as of September 30, 2025, related to lease obligations.)

Net loss

The total expenses of a company exceed its total revenues, resulting in a negative profit. (The company reported a net loss of $3.17 million for the quarter and $2.70 million for the nine months ended September 30, 2025.)

Year-Over-Year Comparison

Compared to the prior year, Cytosorbents has shown revenue growth for both the three-month period (9.0%) and the nine-month period (5.2%). Gross profit margins have improved to 70.7% from approximately 61.0% in the prior year's nine-month period. However, operating expenses, particularly SG&A, remain high, and the net loss for the quarter widened. A key difference is the substantial foreign currency gain in the current nine-month period, which significantly improved the net loss compared to the prior year, alongside a reduction in R&D expenses.

Key Financial Figures

• $0.001 — ange on which registered Common Stock, $0.001 par value per share CTSO Nasdaq Cap
• $250,000 — Insurance Corporation ("FDIC") up to a $250,000 limit. At times, cash balances may exce

Filing Documents

• ctso-20250930x10q.htm (10-Q) — 1783KB
• ctso-20250930xex10d1.htm (EX-10.1) — 189KB
• ctso-20250930xex10d2.htm (EX-10.2) — 117KB
• ctso-20250930xex10d3.htm (EX-10.3) — 119KB
• ctso-20250930xex31d1.htm (EX-31.1) — 14KB
• ctso-20250930xex31d2.htm (EX-31.2) — 14KB
• ctso-20250930xex32d1.htm (EX-32.1) — 6KB
• ctso-20250930xex32d2.htm (EX-32.2) — 6KB
• 0001104659-25-111389.txt ( ) — 9333KB
• ctso-20250930.xsd (EX-101.SCH) — 63KB
• ctso-20250930_cal.xml (EX-101.CAL) — 72KB
• ctso-20250930_def.xml (EX-101.DEF) — 229KB
• ctso-20250930_lab.xml (EX-101.LAB) — 496KB
• ctso-20250930_pre.xml (EX-101.PRE) — 412KB
• ctso-20250930x10q_htm.xml (XML) — 1758KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

Financial Statements

Item 1. Financial Statements 3 Condensed Consolidated Balance Sheets as of September 30, 2025 (unaudited) and December 31, 2024 3 Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited) 4 Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited) 5 Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024 (unaudited) 6 Notes to Condensed Consolidated Financial Statements (unaudited) 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 25

Quantitative and Qualitative Disclosures About Market Risk

Item 3. Quantitative and Qualitative Disclosures About Market Risk 32

Controls and Procedures

Item 4. Controls and Procedures 33

OTHER INFORMATION

PART II. OTHER INFORMATION

Legal Proceedings

Item 1. Legal Proceedings 35

Risk Factors

Item 1A. Risk Factors 35

Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 37

Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities 37

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 37

Other Information

Item 5. Other Information 37

Exhibits

Item 6. Exhibits 38

Signatures

Signatures 39 This Report includes our trademarks and trade names, such as "CytoSorb," "CytoSorb XL," "ECOS-300CY," "BetaSorb," "ContrastSorb," "DrugSorb," "HemoDefend-RBC," "HemoDefend-BGA, "K+ontrol" and "VetResQ," which are protected under applicable intellectual property laws and are the property of CytoSorbents Corporation and its subsidiaries. This Report also contains the trademarks, trade names and service marks of other companies, which are the property of their respective owners. Solely for convenience, trademarks, trade names and service marks referred to in this Report may appear without the , , or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties' trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by these other parties. 2 Table of Contents

— FINANCIAL INFORMATION

PART I — FINANCIAL INFORMATION

Financial Statements

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 3 Table of Contents CYTOSORBENTS CORPORATION CONDE

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