Revenue and Sales Performance - Product revenue for Q3 2024 was $8.6 million, an 11% increase compared to $7.8 million in Q3 2023[2] - Total revenue for Q3 2024 was $9.4 million, a 7% increase compared to $8.8 million in Q3 2023[2] - CytoSorb product sales generated nearly $34 million in trailing 12-month revenue across 76 countries, with approximately 70% gross margins[5] - Total revenue for the nine months ended September 30, 2024, was $29,071,316, compared to $27,681,164 for the same period in 2023[16] - CytoSorb sales for the nine months ended September 30, 2024, increased to $26,381,455 from $23,681,183 in the same period in 2023[16] Profitability and Losses - Net loss improved to $2.3 million or $0.04 per share in Q3 2024, compared to a net loss of $9.2 million or $0.21 per share in Q3 2023[2] - Adjusted EBITDA loss improved to $3.6 million in Q3 2024, compared to a loss of $5.6 million in Q3 2023[2] - Net loss for the nine months ended September 30, 2024, was $12,835,098, compared to $22,672,487 for the same period in 2023[16] - Net loss for Q3 2024 was $2.334 million, compared to $9.194 million in Q3 2023[19] - Adjusted EBITDA for Q3 2024 was $(3.557) million, compared to $(5.576) million in Q3 2023[19] - Adjusted net loss per share for Q3 2024 was $(0.08), compared to $(0.14) in Q3 2023[18] - Net loss for the nine months ended September 30, 2024 was $12.835 million, compared to $22.672 million in the same period of 2023[19] - Net loss for the full year 2023 was $28.5 million, with quarterly losses ranging from $5.8 million to $9.2 million[21] - Adjusted EBITDA for 2023 was $(25.9) million, with quarterly figures ranging from $(5.9) million to $(7.8) million[21] - Net loss for the first nine months of 2024 was $12.8 million, with quarterly losses decreasing from $6.4 million to $2.3 million[23] - Adjusted EBITDA for the first nine months of 2024 was $(9.3) million[23] Gross Margins and Profit - Product gross margins decreased to 61% in Q3 2024, down from 72% in Q3 2023 due to a planned production slowdown and a resolved manufacturing issue[2] - Gross profit for the nine months ended September 30, 2024, was $18,354,922, compared to $17,080,743 for the same period in 2023[16] Regulatory and Market Opportunities - The total addressable market (TAM) for DrugSorb-ATR in North America is estimated at $300 million, with potential growth to over $600 million post-Brilinta generics and further expansion to $1-2 billion with broader applications[4] - The company submitted a De Novo application for DrugSorb-ATR to the U.S. FDA on September 27, 2024, and received acceptance for substantive review on October 22, 2024[3] - CytoSorbents received MDSAP certification on November 1, 2024, enabling compliance with regulatory requirements in the U.S., Canada, Brazil, Japan, and Australia[3] - The company submitted a Medical Device License (MDL) application to Health Canada for DrugSorb-ATR on November 1, 2024[3] Financial Position and Assets - Cash and cash equivalents decreased to $5,685,328 as of September 30, 2024, from $14,131,137 as of December 31, 2023[15] - Total current assets decreased to $16,597,368 as of September 30, 2024, from $25,702,823 as of December 31, 2023[15] - Total liabilities increased to $34,804,921 as of September 30, 2024, from $29,985,471 as of December 31, 2023[15] - Total stockholders' equity decreased to $12,999,090 as of September 30, 2024, from $23,275,163 as of December 31, 2023[15] - Total stockholders' equity as of September 30, 2024 was $12.999 million[17] - Accumulated deficit as of September 30, 2024 was $(295.340) million[17] Expenses and Compensation - Research and development expenses for the nine months ended September 30, 2024, decreased to $5,619,040 from $11,632,416 in the same period in 2023[16] - Stock-based compensation expense for Q3 2024 was $0.781 million[17] - Non-cash stock-based compensation expense for Q3 2024 was $0.458 million[19] - Non-cash stock-based compensation expense for 2023 totaled $3.7 million[21] - Non-cash stock-based compensation expense for the first nine months of 2024 was $2.2 million[23] - Depreciation and amortization expense for the first nine months of 2024 was $1.2 million[23] - Interest expense for the first nine months of 2024 was $775,000[23] Share and Earnings Metrics - Basic and diluted net loss per common share for the nine months ended September 30, 2024, was $(0.24), compared to $(0.52) for the same period in 2023[16] - Weighted average common shares outstanding for Q3 2024 was 54.453 million[18] - Weighted average common shares outstanding for 2024 YTD was approximately 54.3 million, with a loss per share of $(0.24)[22] - Adjusted net income (loss) per common share for 2024 YTD was $(0.21)[22] Foreign Currency and Other Items - Foreign currency translation loss for Q3 2024 was $(2.650) million[19]

Financial Performance - CytoSorbents Corporation announced preliminary financial results for the quarter ended September 30, 2024, including estimated ranges for quarterly product sales and product gross margins[3] Regulatory Submissions and Approvals - The company submitted its DrugSorb™-ATR medical device De Novo marketing application to the FDA for reducing perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery[3] - DrugSorb-ATR has been granted Breakthrough Device Designation by the FDA, making it eligible for priority review[3] - The company completed its DrugSorb-ATR Health Canada Medical Device License application, pending Medical Device Single Audit Program certification[3]

Financial Data and Key Metrics - Total revenue increased 5% to $9.9 million in Q2 2024, with product sales up 10% to $8.8 million [4] - Gross product margins remained strong at 75% in Q2 2024, compared to 74% in Q2 2023 [4] - Operating loss decreased by 48% to $3.4 million in Q2 2024 from $6.6 million in Q2 2023 [5] - Cash balance at the end of Q2 2024 was $14.9 million, including $8.5 million in unrestricted cash and $6.5 million in restricted cash [5] - Annualized cost savings of $5 million expected from recent cutbacks, with a 17% reduction in workforce over the past five months [5] Business Line Data and Key Metrics - CytoSorb product revenue increased by 10% to $8.8 million in Q2 2024 compared to $8.1 million in Q2 2023 [7] - Grant revenue decreased to $1.1 million in Q2 2024 from $1.3 million in Q2 2023 due to the conclusion of several grants [8] - Cumulative delivery of CytoSorb devices surpassed 0.25 million units [4] - The PuriFi hemoperfusion pump received positive reviews and all 30 pumps from the initial order were placed, with the next order expected soon [6] Market Data and Key Metrics - Core non-COVID-19 product sales showed positive growth, with a 9.5% year-over-year increase in trailing 12-month sales ending June 30, 2024 [10] - The STAR registry data was presented at the EuroPCR 2024 Conference and selected as a top five finalist in the best scientific abstract competition [6][16] - The company completed its MDSAP audit, a key requirement for Canadian commercialization [6] Company Strategy and Industry Competition - The company is on track to submit marketing applications for the DrugSorb-ATR system to the FDA and Health Canada in Q3 2024 [6][15] - The company secured a $20 million credit facility with Avenue Capital Group to strengthen its balance sheet [5] - Cost-cutting measures and operational efficiencies are expected to further reduce cash burn and improve margins [13][25] - The company is focusing on expanding its core CytoSorb sales and preparing for potential U.S. and Canadian market entry [26] Management Commentary on Operating Environment and Future Outlook - Management expects gross margins to approach 80% with 15-20% year-over-year growth [36] - The company anticipates FDA and Health Canada regulatory decisions within 6-12 months following the submission of the DrugSorb-ATR application [15] - Management remains committed to cost reduction and operational efficiency to achieve self-sustainability [25] Other Important Information - The company announced the retirement of CFO Kathleen Bloch and the appointment of Peter Mariani as the new CFO [5][29] - The company launched a redesigned corporate and product website [6] - The company received MDR certification for the PuriFi pump and completed registration in Taiwan [24] Q&A Session Summary Question: Update on FDA and Health Canada submission for DrugSorb-ATR - The company is on track for Q3 2024 submissions and believes the STAR-T trial data supports a robust benefit/risk analysis [33][34] Question: Gross margin outlook and factors driving improvement - Gross margins are expected to approach 80% with 15-20% year-over-year growth, driven by volume increases and operational efficiencies [36][39] Question: Revenue growth drivers in Q2 2024 and outlook for Q3 - Revenue growth in Q2 was driven by strength in the distributor and partner channel, particularly with the launch of the PuriFi pump [42][43] Question: Impact of PuriFi pump on revenue growth - The PuriFi pump is expected to drive CytoSorb device sales rather than generate significant hardware revenue [45][46] Question: Timing of Canadian submission for DrugSorb-ATR - The company aims to submit to Health Canada in Q3 2024, prioritizing the FDA submission first [48] Question: R&D expenses and future outlook - R&D expenses decreased to $1.5 million in Q2 2024 due to the completion of the STAR-T trial and focus on grant-funded activities [50] Question: Potential of the Taiwan market - Taiwan represents a significant opportunity due to its large market and strong interest in blood purification, though it remains to be seen how it will develop [51] Question: Status of the $15 million loan - The loan was closed on the last day of Q2 2024 [52] Question: Major grant-supported R&D projects - The company is focusing on HemoDefend-BGA, with progress toward human testing and potential military and civilian applications [53][54]

New CFO Peter J. Mariani to succeed retiring CFO Kathleen P. Bloch On track for DrugSorb™-ATR U.S. FDA De Novo and Health Canada marketing submissions this quarter In Q2 2024, increased product sales by 10% and reduced operating loss by 48% Achieved more than a quarter million CytoSorb treatments cumulatively delivered to date – a major company milestone PRINCETON, N.J., Aug. 13, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a pioneer in critical care and cardiac surgery blood purificati ...

PRINCETON, N.J., Aug. 13, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the appointment of Peter J. Mariani as Chief Financial Officer (CFO), effective August 14, 2024. Mr. Mariani will report to Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. Concurrently, Kathleen P. Bloch, CytoSorbents' ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36792 CYTOSORBENTS CORPORATION (Exact name of registrant as specified in its charter) Delaware 98-0373793 (State or other jurisdiction of (I.R.S. Employer ...

PRINCETON, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, will report second quarter 2024 operating and financial results after the market close on Tuesday, August 13, 2024. CytoSorbents' management will host a live conference call, presentation webcast, and a question and answer session starting at 4:30PM EDT the same day. Webcast Details: Date: ...

The new website, built from the ground up, unifies our corporate and product information into a single, cohesive and comprehensive information hub for healthcare professionals, investors, and other key stakeholders. Visitors will find a streamlined modern design, intuitive navigation, and extensive content on our company, technology, therapies, pipeline that includes DrugSorb™-ATR and HemoDefend-BGA™, clinical studies, investor conferences, and much more. Key Features of the New Website: User-Friendly Layou ...

PRINCETON, N.J., July 30, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, is proud to announce the launch of its newly redesigned and consolidated website at www.cytosorbents.com. The theme of "Working to Save Lives Together" highlights two decades of successful collaboration with the international medical and research com ...

PRINCETON, N.J., July 17, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces it will present at the 1st Annual American Association of Physicians of Indian Origin (AAPI) World Health Congress, taking place on July 18- 22, 2024 at the Mariott Marquis Hotel in New York, NY. This event will host over 3,000 ph ...