Cytosorbents Corp (CTSO) SEC Filings & Earnings Calls

Continued non-compliance with MVLS requirement could lead to delisting if not resolved by December 28, 2026.

“If the Company does not regain compliance prior to December 28, 2026, the Company will receive written notification that its securities are subject to delisting.” · word for word

Regulatory approval risk for DrugSorb-ATR in US and Canada.

“DrugSorb-ATR is NOT yet cleared/approved by FDA, Health Canada.”

Geopolitical risk from war in Iran.

“Impact of geopolitical events including the recent war in Iran.” · word for word

Debt covenant compliance risk.

“Ability to meet our financial obligations and comply with the covenants under our existing debt agreement.” · word for word

Low cash position ($5.9M) with ongoing losses; need for additional financing if breakeven delayed.

“Total cash, cash equivalents, and restricted cash was approximately $5.9 million on June 30, 2026” · word for word

Germany sales decline 24% due to smaller sales force; recovery dependent on hiring.

“24% decrease in Germany sales, attributed to a smaller, but more focused sales force” · word for word

Regulatory risk: FDA approval for DrugSorb-ATR uncertain; key value driver.

“Third Value Driver: Opening the U.S. Market Through DrugSorb-ATR” · word for word

Going Concern Uncertainty

“raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued” · word for word

Nasdaq Delisting Risk

“the Company received notice from the Staff Nasdaq that it was not in compliance with the Minimum Bid Price Requirement” · word for word

FDA Approval Delay

“the FDA identified no concerns regarding device safety but upheld the prior denial of the application and requested additional analysis of real-world evidence” · word for word

Liquidity Risk

“As of June 30, 2026, we had approximately $5.9 million in cash... which may not be sufficient to fund the Company’s operations beyond the next twelve months”

Potential delisting from Nasdaq if compliance not regained by December 28, 2026.

“If the Company does not regain compliance prior to the Compliance Date, the Company will receive written notification that its securities are subject to delisting”

Low market value may indicate investor concerns about financial stability.

“market value of the Company’s common stock must meet or exceed $35 million for a minimum of 10 consecutive business days” · word for word

Regulatory approval uncertainty; no FDA clearance for DrugSorb-ATR yet.

“DrugSorb-ATR is INVESTIGATIONAL DEVICE: Limited by U.S. Federal Law to Investigational Use Only”

Nasdaq Delisting Risk

“On October 2, 2025, the Company received written notice... that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2)”

Reverse Stock Split Dilution/Liquidity Risk

“the proposed Reverse Stock Split may decrease the liquidity of our Common Stock and result in higher transaction costs” · word for word

Liquidity/Going Concern Risk

“the Compensation Committee approved cash bonuses... and then deferred the payment of these bonuses pending the Compensation Committee’s determination of sufficient liquidity”

Performance Milestone Failure

“the Committee determined that these specific long-term milestones were not achieved, and the stock options for each of the executives were forfeited as of December 31, 2025.” · word for word

Regulatory delay for DrugSorb-ATR De Novo submission to late 2026/early 2027 due to FDA request for additional mechanistic data.

“FDA has requested additional mechanistic data to be included alongside the real-world evidence within the new De Novo submission.” · word for word

Geopolitical instability in Middle East causing delayed distributor orders of ~$500,000.

“Distributor orders of approximately $500,000 in parts of the Middle East and neighboring regions delayed due to geopolitical and economic instability related to the U.S.-Iran war.”

Cash burn continues with $6.4M cash; goal of operating cash flow breakeven in H2 2026.

“Total cash, cash equivalents, and restricted cash was approximately $6.4 million, compared to $7.8 million as of December 31, 2025.” · word for word

Going Concern Risk

“raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued.” · word for word

FDA Regulatory Delay

“FDA upheld the prior denial of the application and requested additional information... anticipate completing the required work and submitting a new De Novo application in late 2026 or early 2027.”

Geopolitical Disruption

“delayed distributor orders of approximately $0.5 million in parts of the Middle East and neighboring regions due to geopolitical and economic instability related to the U.S.-Iran war.” · word for word

Currency Risk

“loss on foreign currency transactions was approximately $1.2 million, as compared to a gain on foreign currency transactions of approximately $3.0 million for the three months ended March 31, 2025.” · word for word

Going Concern Risk

“As of December 31, 2025, we have approximately $7.8 million in cash (a non-GAAP measure), including approximately $6.3 million in unrestricted cash and cash equivalents, and $1.5 million of non-current restricted cash which may not be sufficient to fund the Company’s operations beyond the next twelve months from the issuance of these consolidated financial s”

FDA Approval Delay

“On September 16, 2025, the Company announced that it would file a new De Novo application for DrugSorb-ATR with the FDA. This decision followed an appeal meeting and decision by the FDA that upheld its previous denial of the Company’s DrugSorb-ATR De Novo application, but affirmed that there were no safety related issues with the device, and requested additi”

Nasdaq Delisting Risk

“On October 2, 2025, we were notified that we were not in compliance with the Nasdaq’s continued listing requirements relating to the minimum average closing price per share of our common stock, because the average closing price of our common stock over a consecutive 30 trading-day period was below $1.00 per share” · word for word

Material Weakness in Internal Controls

“As discussed above, our management has concluded that we did not maintain effective internal control over financial reporting as of December 31, 2025, due to a material weakness relating to the accounting for stock-based compensation corresponding to grants of restricted stock units.” · word for word

High Debt and Interest Expense

“For the year ended December 31, 2025, net interest expense was approximately $2.6 million, as compared to $1.4 million for the year ended December 31, 2024.” · word for word

Cash burn and limited runway; cash $7.8M with operating loss $14.7M; additional debt taken.

“Total cash, cash equivalents, and restricted cash of $7.8 million on December 31, 2025... Operating loss for 2025 improved by 10% to $14.7 million.”

Regulatory uncertainty for DrugSorb-ATR; FDA De Novo submission content and timing not finalized.

“Ongoing Interactive Discussions with FDA to Determine Content and Timing of New De Novo Application for DrugSorb™ -ATR.” · word for word

German sales decline due to restructuring; recovery uncertain.

“10% reduction in Germany sales to $11.8 million, reflecting the near-term impact of our proactive restructuring of German sales operations.” · word for word

Cash burn continues; proforma cash $11.6M; reliance on FDA approval for additional liquidity.

“Cash $9.1M; operating cash burn $2.6M in quarter; additional $2.5M contingent on FDA approval.”

German market decline; commercial reorganization may impact near-term sales.

“Decline in direct German market; proactive reorganization of commercial team.”

FDA approval uncertainty for DrugSorb-ATR; prior denial; new submission may face delays.

“FDA upheld prior denial; new De Novo submission planned Q1 2026; decision mid-2026.”

Going Concern Risk

“As of September 30, 2025, we had approximately $9.1 million in cash, including approximately $7.6 million in unrestricted cash and cash equivalents and $1.5 million of non-current restricted cash. These cash and restricted cash balances considered with our historical cash used in operations, notwithstanding our Strategic Workforce and Cost Reduction Plan and” · word for word

FDA Approval Delay

“A formal meeting with the FDA is anticipated in either late fourth quarter of 2025, or early 2026 to confirm the requirements for the new De Novo submission, followed by a formal submission in the first quarter of 2026. A regulatory decision is expected in mid-2026 following a typical 150-day review process.” · word for word

High Debt and Interest Expense

“Interest expense, net (645) (6.8) % (588) (6.8) %”

Dilution Risk from Equity Financing

“The sale of additional equity may result in dilution to our shareholders.” · word for word