Cytosorbents Corp (CTSO) SEC Filings

CytoSorbents Corporation (CTSO) implemented a 1-for-20 reverse stock split of its common stock, effective at 12:01 a.m. E.T. on September 8, 2026. As of September 3, 2026, there were 63,022,020 shares of common stock outstanding that became subject to this reclassification.

Every twenty previously issued and outstanding shares of common stock were automatically reclassified into one share, with no change to the $0.001 par value and no change to the total number of authorized shares. Fractional entitlements were rounded up to the nearest whole share, and outstanding options and warrants were proportionately adjusted in both share amount and exercise price. Trading continues on Nasdaq on a split-adjusted basis under CTSO, with a new CUSIP of 23283X305.

CytoSorbents Corporation held its 2026 Annual Meeting of Stockholders on August 13, 2026. Stockholders representing 42,487,327 of 62,842,748 outstanding common shares were present in person or by proxy, constituting a quorum. Five directors, including Dr. Phillip P. Chan, were elected with support levels generally above 23.6 million votes in favor for each nominee, with substantial broker non-votes recorded.

On a non-binding, advisory basis, compensation of named executive officers received 21,831,424 votes for, 2,988,267 against, and 2,642,933 abstentions. Stockholders ratified WithumSmith+Brown, PC as independent registered public accounting firm for 2026 with 41,517,193 votes for. They also approved a charter amendment authorizing a reverse stock split at a ratio between 1-for-5 and 1-for-20, to be implemented at the Board’s discretion within one year of the meeting, and approved a potential adjournment proposal, though no adjournment was needed.

CytoSorbents Corporation furnished an investor presentation outlining Q2 2026 performance and strategic priorities. Product revenue was $9.6 million, flat year over year, with growth from distributors and strategic partners and direct international sales offset by lower German revenue following a salesforce restructuring. Gross margin improved to 73%, total operating expenses declined to $9.7 million from $10.4 million, and operating loss narrowed to ($2.6 million). Reported net income was $1.9 million, or $0.03 per share, compared with a $4.4 million loss a year earlier, while adjusted net loss was ($2.9 million) and adjusted EBITDA loss ($1.6 million). Cash, cash equivalents and restricted cash totaled $5.9 million with net operating cash burn of about $0.4 million in Q2, including $0.2 million of restructuring payments; management continues to target operating cash flow breakeven in the second half of 2026.

Management highlights four value drivers: achieving operating cash flow breakeven, returning core CytoSorb sales to growth, opening the U.S. market with DrugSorb-ATR, and unlocking the value of HemoDefend-BGA. Trailing twelve-month core product sales reached $37.3 million as of June 30, 2026, with more than 300,000 CytoSorb treatments performed in over 70 countries. For DrugSorb-ATR, the pivotal STAR-T trial showed a 58% risk reduction and 16.3% absolute reduction in major bleeding (NNT=6) despite missing its primary endpoint, leading to an FDA De Novo denial. On appeal, FDA raised no major safety concerns, indicated a new large trial is not required, and invited a focused new De Novo submission supported by additional mechanistic data and real-world evidence from European use. The company is also exploring a parallel De Novo pathway for direct oral anticoagulant removal. HemoDefend-BGA, a gravity-driven filter to create universal plasma and blood products, has been developed with more than $16 million in non-dilutive government funding; the company recently received constructive FDA feedback on a planned clinical pathway and is preparing for clinical trials while positioning the asset for potential partnerships, licensing, or other strategic options.

CytoSorbents Corporation reported second quarter 2026 net revenue of $9,633k, compared with $9,617k a year earlier, with product gross margin rising to 73%. Operating expenses were $9,687k, yielding a loss from operations of $2,638k and a net loss of $4,417k versus net income of $1,947k in the prior-year quarter. Adjusted EBITDA improved to a loss of $1,649k from a $2,640k loss, and operating cash burn fell to about $200k excluding restructuring payments. Since September 2025 the workforce has been reduced by approximately 23% to create a leaner organization.

As of June 30, 2026, cash and cash equivalents totaled $4,413k, restricted cash $1,522k, total assets $37,960k, and stockholders’ equity was a deficit of $751k driven by an accumulated deficit of $321,754k. Management highlighted four value drivers over the next 6–18 months: achieving sustainable operating cash flow breakeven, returning the CytoSorb franchise to profitable growth, pursuing FDA De Novo submissions and potential marketing authorization for DrugSorb-ATR in a U.S. and Canada market estimated at $500 million to $1 billion, and realizing the strategic value of HemoDefend-BGA, developed with roughly $16 million of prior non-dilutive U.S. government funding.

CytoSorbents Corporation reported Q2 2026 revenue of $9.6 million, essentially flat year over year, with gross margin improving to 73.2%. Loss from operations narrowed to $2.6 million, but a foreign‑currency loss and higher interest drove a net loss of $4.4 million versus prior‑year profit.

Cash, cash equivalents and restricted cash totaled $5.9 million at June 30, 2026, compared with $18.4 million of Avenue Capital term debt due in 2027. Management states that these cash levels, debt obligations and expected cash use raise substantial doubt about the company’s ability to continue as a going concern over the next 12 months.

Operating expenses declined, aided by a Strategic Workforce and Cost Reduction Plan that reduced headcount by about 23% and generated approximately $0.3 million of Q2 restructuring charges. The company continues to pursue U.S. FDA De Novo clearance for its DrugSorb‑ATR antithrombotic removal system, now targeting a new submission in early 2027.

CytoSorbents Corporation reported that it received a notice from Nasdaq stating it is not in compliance with Nasdaq Listing Rule 5550(b)(2), which requires a minimum Market Value of Listed Securities of $35 million for the Nasdaq Capital Market.

The company has 180 calendar days, until December 28, 2026, to regain compliance by having its market value meet or exceed $35 million for at least 10 consecutive business days, subject to potential Nasdaq discretion. The notice does not immediately delist the stock, but failure to regain compliance could lead to a delisting determination, which the company could then appeal.

CytoSorbents is evaluating potential actions to regain compliance, including actively monitoring its market value and potentially increasing stockholders’ equity to at least $2.5 million as another route to satisfy Nasdaq’s continued listing standards. The filing notes there is no assurance the company will succeed in maintaining its Nasdaq Capital Market listing.

CytoSorbents Corporation is asking stockholders to approve five proposals at its 2026 virtual annual meeting. The meeting will be held online on August 13, 2026, for holders of common stock of record as of June 15, 2026, when 62,842,748 shares were outstanding.

Stockholders will vote on re-electing five directors, a non-binding advisory Say‑on‑Pay proposal on executive compensation, ratifying WithumSmith+Brown, PC as auditor for 2026, and a reverse stock split at a Board‑selected ratio between 1‑for‑5 and 1‑for‑20. The reverse split is intended to help restore compliance with Nasdaq’s $1.00 minimum bid price after a deficiency notice and an extension to September 28, 2026. An adjournment proposal would allow the meeting to be postponed if additional votes are needed.

CytoSorbents Corporation furnished an investor presentation describing its blood purification business and regulatory plans for its DrugSorb-ATR device. The company has scheduled two FDA pre-submission meetings in August 2026 to discuss ticagrelor removal in cardiac surgery and a potential expanded indication for DOAC removal.

The presentation highlights 2025 sales of $37 with 71% gross margins and a high-margin "razorblade" consumables model across more than 70 countries and 300,000+ CytoSorb treatments. In Q1 2026, sales were $8, up 2% year over year, with product gross margins of 69% as the company deliberately slowed production to reduce inventory.

Management reports negative free cash flow improving, ending Q1 2026 with $6.4 million in cash, cash equivalents and restricted cash and a cash burn of $1.1 million in the quarter. The company aims for operating cash flow breakeven in the second half of 2026 and targets profitability in 2027 while pursuing De Novo submissions for DrugSorb-ATR in North America.