Core Insights - CytoSorbents Corporation has appointed Peter J. Mariani as the new CFO, succeeding Kathleen P. Bloch, who is retiring after over 11 years with the company [1][11] - The company is on track to submit marketing applications for DrugSorb™-ATR to the U.S. FDA and Health Canada this quarter, which could unlock a significant commercial opportunity with an estimated total addressable market of $325 million [3][34] - In Q2 2024, the company reported a 10% increase in product sales and a 48% reduction in operating loss, achieving a cumulative milestone of over 250,000 CytoSorb treatments delivered [2][8] Financial Performance - Total revenue for Q2 2024 was approximately $9.9 million, a 5% increase from $9.4 million in Q2 2023 [2][15] - Product sales in Q2 2024 reached $8.8 million, up from $8.1 million in Q2 2023, reflecting a 10% increase [2][13] - The operating loss decreased to $3.4 million in Q2 2024 from $6.6 million in the same quarter last year, attributed to cost-cutting measures and increased sales [2][5] Cost Management and Efficiency - The company has implemented additional cost-cutting measures expected to save an additional $5 million annually, reducing headcount by 17% over the past five months [5][6] - Product gross margins improved to approximately 75% in Q2 2024, compared to 74% in Q2 2023, due to operational efficiencies [2][16] - The company aims to achieve 80% blended product gross margins through increased sales volume and improved manufacturing processes [7] Market and Product Development - CytoSorbents has delivered over 250,000 CytoSorb devices across 76 countries, marking a significant achievement in its product distribution [8] - The company is actively working on the launch of its PuriFi® pump and collaborating with Fresenius Medical Care to co-market CytoSorb at upcoming medical conferences [10] - The DrugSorb™-ATR system has received two FDA Breakthrough Device Designations, indicating its potential impact in cardiothoracic procedures [34] Liquidity and Capital Resources - As of June 30, 2024, the company had total cash of $14.9 million, which is expected to fund operations into Q2 2025 [32] - The company secured a $20 million term-loan facility to support its regulatory submissions and operational needs [30][31] - Current assets were approximately $21.96 million, with current liabilities of about $10.34 million, indicating a healthy liquidity position [29][39]

Core Points - CytoSorbents Corporation has appointed Peter J. Mariani as Chief Financial Officer (CFO), effective August 14, 2024, following the retirement of Kathleen P. Bloch [1][3] - Mr. Mariani has over 25 years of experience in financial leadership within high-growth medical device companies, including his recent role as CFO of Axogen, Inc., where he significantly increased annual revenue from $27 million to nearly $160 million [2][3] - The company is pursuing U.S. and Canadian marketing approval for its investigational device, DrugSorb-ATR, which is expected to enhance its growth in the cardiac surgery market [3][4] Company Overview - CytoSorbents Corporation specializes in blood purification technologies for life-threatening conditions in intensive care and cardiac surgery, with its lead product, CytoSorb®, approved in the European Union and distributed in 76 countries [5] - CytoSorb® is designed to reduce cytokine storms and is used during cardiothoracic surgery to mitigate complications such as severe bleeding and organ failure [5] - The company has received FDA Emergency Use Authorization for CytoSorb® in critically ill COVID-19 patients [5] Product Development - The DrugSorb™-ATR system has received two FDA Breakthrough Device Designations for removing specific anticoagulants during cardiothoracic procedures, with a pivotal study completed to support regulatory approval [6] - CytoSorbents has developed various products based on its proprietary polymer adsorption technology, with significant funding received from multiple U.S. government agencies totaling approximately $50 million [7]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's financial information, including consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited consolidated financial statements for Q2 and H1 2024, including a going concern disclosure due to current cash position - Management expresses substantial doubt about the company's ability to continue as a going concern, as current unrestricted cash is insufficient for operations beyond the next twelve months without additional capital[13](index=13&type=chunk) Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | June 30, 2024 ($) | December 31, 2023 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $8,458,708 | $14,131,137 | | Total current assets | $21,955,300 | $25,702,823 | | Total Assets | $53,426,791 | $53,260,634 | | **Liabilities & Equity** | | | | Total current liabilities | $10,336,268 | $14,545,955 | | Long-term debt | $13,673,195 | $2,542,857 | | Total Liabilities | $36,690,188 | $29,985,471 | | Total Stockholders' Equity | $16,736,603 | $23,275,163 | Consolidated Statements of Operations Highlights (Unaudited) | Metric | Q2 2024 ($) | Q2 2023 ($) | H1 2024 ($) | H1 2023 ($) | | :--- | :--- | :--- | :--- | :--- | | Total product sales | $8,841,789 | $8,072,412 | $17,831,309 | $15,982,451 | | Total revenue | $9,894,636 | $9,420,821 | $19,680,928 | $18,870,317 | | Gross profit | $6,502,729 | $6,018,550 | $13,073,307 | $11,473,877 | | Loss from operations | ($3,418,822) | ($6,559,237) | ($8,344,341) | ($14,450,832) | | Net loss | ($4,143,146) | ($6,153,084) | ($10,501,007) | ($13,478,967) | | Basic and diluted net loss per share | ($0.08) | ($0.14) | ($0.19) | ($0.31) | Consolidated Statements of Cash Flows Highlights (Unaudited, Six Months Ended June 30) | Cash Flow Activity | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,624,412) | ($10,041,497) | | Net cash used in investing activities | ($246,883) | ($542,599) | | Net cash provided by financing activities | $9,262,875 | $1,615,401 | | Net change in cash, cash equivalents and restricted cash | ($672,429) | ($8,993,043) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business overview, strategic objectives, financial performance for Q2 and H1 2024, liquidity challenges, and ongoing going concern uncertainty [Overview and Key Objectives](index=42&type=section&id=Overview%20and%20Key%20Objectives) The company, a leader in blood purification, focuses on three key objectives: DrugSorb-ATR regulatory approval, CytoSorb sales growth, and cash burn reduction - The company's three primary strategic objectives include obtaining **FDA and Health Canada marketing approval for DrugSorb™-ATR**, growing **core CytoSorb sales to achieve profitability**, and **reducing cash burn** through expense control[123](index=123&type=chunk) - **CytoSorb** has been used in over **248,000 human treatments globally** and holds CE-Mark label expansions and FDA Emergency Use Authorization for specific conditions[120](index=120&type=chunk) [Clinical Studies Update](index=46&type=section&id=Clinical%20Studies%20Update) The completed STAR-T trial for DrugSorb-ATR met safety but not overall effectiveness, showing reduced bleeding in the CABG subgroup, supporting Q3 2024 regulatory submissions - The pivotal **STAR-T trial** for DrugSorb-ATR met its primary safety endpoint but not overall effectiveness, though it showed **reduced bleeding in the CABG surgery subgroup** (>90% of patients)[130](index=130&type=chunk) - The company plans parallel regulatory submissions of **DrugSorb-ATR to the FDA and Health Canada in Q3 2024** based on STAR-T trial data[130](index=130&type=chunk) - The **STAR-D study** for DOAC removal has been **postponed** to prioritize STAR-T regulatory filings[131](index=131&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) Comparative financial analysis for Q2 and H1 2024 shows increased product sales, improved gross margins, and reduced operating expenses, leading to a lower net loss Revenue Comparison (Q2 2024 vs Q2 2023) | Revenue Source | Q2 2024 ($) | Q2 2023 ($) | Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Product Sales | $8,842,000 | $8,072,000 | +$770,000 | +10% | | Grant Income | $1,053,000 | $1,348,000 | -$295,000 | -22% | | **Total Revenue** | **$9,895,000** | **$9,421,000** | **+$474,000** | **+5%** | Revenue Comparison (H1 2024 vs H1 2023) | Revenue Source | H1 2024 ($) | H1 2023 ($) | Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Product Sales | $17,831,000 | $15,982,000 | +$1,849,000 | +12% | | Grant Income | $1,850,000 | $2,888,000 | -$1,038,000 | -36% | | **Total Revenue** | **$19,681,000** | **$18,870,000** | **+$811,000** | **+4%** | - **R&D expenses decreased by approximately $2.1 million in Q2 2024 and $4.1 million in H1 2024** due to the completion of the STAR-T clinical trial[153](index=153&type=chunk)[159](index=159&type=chunk) - Product gross margins improved from **74% to 75% in Q2 2024** and from **71% to 74% in H1 2024**, driven by operating efficiencies at the new manufacturing facility[152](index=152&type=chunk)[158](index=158&type=chunk) [Liquidity and Capital Resources](index=57&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company had $8.4 million unrestricted cash, raising going concern doubt, despite securing a new $20 million term-loan facility with Avenue Capital Group - The company's **$8.4 million in unrestricted cash** as of June 30, 2024, is expected to fund operations into Q2 2025, raising **substantial doubt about going concern**[167](index=167&type=chunk)[173](index=173&type=chunk) - In June 2024, the company secured a **$20 million term-loan facility with Avenue Capital Group**, with an initial **$15 million tranche funded**, providing **$10 million in unrestricted cash** and repaying existing debt[165](index=165&type=chunk) - The company is pursuing milestones for the Avenue debt facility to potentially release an additional **$5 million in restricted cash** and access another **$5 million tranche**, increasing unrestricted cash by up to **$10 million**[167](index=167&type=chunk)[173](index=173&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that quantitative and qualitative disclosures about market risk are not applicable for this period - Quantitative and qualitative disclosures about market risk are **not applicable** for this reporting period[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=61&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures are effective, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's **disclosure controls and procedures are functioning effectively** as of the period end[176](index=176&type=chunk) - No material changes to **internal control over financial reporting** occurred during the quarter[177](index=177&type=chunk) [PART II. OTHER INFORMATION](index=62&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings) The company is not party to material litigation but is defending against a former employee's CEPA complaint filed March 5, 2024 - A former employee filed a complaint on **March 5, 2024**, alleging retaliatory termination under the **New Jersey CEPA**[180](index=180&type=chunk) - The company disputes the CEPA allegations and intends to **defend vigorously**, though the outcome is not assured[180](index=180&type=chunk) [Item 1A. Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the company's Annual Report on Form 10-K for a comprehensive discussion of business risks - For a discussion of business risks, the company refers to **Part I, Item 1A, 'Risk Factors' in its Annual Report on Form 10-K** for the year ended December 31, 2023[181](index=181&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=62&type=section&id=Other%20Items) The company reports no activity for unregistered sales of equity securities, defaults upon senior securities, mine safety disclosures, or other information - The company reported **'None' or 'Not applicable'** for Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), and Item 5 (Other Information)[181](index=181&type=chunk) [Item 6. Exhibits](index=63&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including XBRL financial statements and Sarbanes-Oxley Act officer certifications - Exhibits include **XBRL financial data** and **officer certifications** pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[182](index=182&type=chunk)

Core Insights - CytoSorbents Corporation will report its second quarter 2024 operating and financial results on August 13, 2024, after market close [1] - A live conference call and presentation will be held at 4:30 PM EDT on the same day [2] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification [3] - The company's lead product, CytoSorb®, is an extracorporeal cytokine adsorber approved in the EU and distributed in 75 countries, designed to reduce cytokine storms in critical illnesses [3] - As of March 31, 2024, over 237,000 CytoSorb devices have been used cumulatively [3] Product Development - The investigational DrugSorb™-ATR system has received two FDA Breakthrough Device Designations for removing specific anticoagulants during cardiothoracic procedures [4] - The STAR-T study, involving 140 patients across approximately 30 centers in the U.S. and Canada, evaluated the safety and efficacy of DrugSorb-ATR [4] Funding and Technology - CytoSorbents has secured approximately $50 million in funding from various U.S. government agencies for its purification technologies [5] - The company holds numerous patents and has multiple products under development based on its blood purification technology [5]

Core Insights - CytoSorbents Corporation has launched a newly redesigned website that serves as a comprehensive information hub for healthcare professionals, investors, and other stakeholders, emphasizing the theme "Working to Save Lives Together" [1][5][11] Company Overview - CytoSorbents Corporation is a leader in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery, with its flagship product, CytoSorb®, approved in the EU and distributed in 75 countries [11] - The company has developed various products based on proprietary polymer adsorption technology, which has received approximately $50 million in funding from multiple U.S. government agencies [8][11] Website Features - The new website features a user-friendly layout optimized for both desktop and mobile, providing easy access to essential information [2] - It includes a comprehensive resource library with over 1,000 peer-reviewed publications and other materials related to the company's therapies [2] - The site also offers dedicated sections for news updates, investor relations, and improved contact forms for faster communication [2] Product Information - CytoSorb® is designed to reduce cytokine storms in critical illnesses, with over 237,000 devices used cumulatively as of March 31, 2024 [11] - The DrugSorb™-ATR system, an investigational device, has received two FDA Breakthrough Device Designations for removing specific anticoagulants during cardiothoracic procedures [12]

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 ...

Company Overview - CytoSorbents Corporation (NASDAQ: CTSO) specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [1][7] - The company's lead product, CytoSorb®, is an extracorporeal cytokine adsorber that mitigates "cytokine storm" in critical illnesses, significantly reducing inflammation and organ failure risks [7] - As of March 31, 2024, over 237,000 CytoSorb devices have been utilized globally, with the product approved in the European Union and distributed in 75 countries [7] Recent Developments - CytoSorbents will present at the 1st Annual American Association of Physicians of Indian Origin (AAPI) World Health Congress from July 18-22, 2024, in New York, engaging with over 3,000 healthcare professionals [1][2] - Dr. Phillip Chan, CEO of CytoSorbents, will participate in a panel discussion on the role of artificial intelligence in healthcare, highlighting the company's historical involvement with DARPA in developing smart diagnostic systems for sepsis [1][6] Product Innovations - The DrugSorb™-ATR system, an investigational device for antithrombotic removal, has received two FDA Breakthrough Device Designations for use in urgent cardiothoracic procedures [3][11] - CytoSorbents' technologies are supported by approximately $50 million in funding from various U.S. government agencies, indicating strong institutional backing for its research and development efforts [8] Market Position - The AAPI represents over 80,000 practicing physicians in the U.S., with its members accounting for about 10% of all physicians and serving approximately 30% of the U.S. patient population, providing a significant platform for CytoSorbents to increase awareness of its technologies [2]

Core Insights - CytoSorbents Corporation will present at the 1st Annual AAPI World Health Congress, highlighting its role in blood purification for critically ill patients [1][2] - The company aims to increase awareness of its technologies among healthcare professionals and discuss the impact of artificial intelligence in critical care [2] - CytoSorbents' lead product, CytoSorb®, is approved in the EU and used in 75 countries, addressing cytokine storms in critical illnesses [3] Company Overview - CytoSorbents Corporation specializes in blood purification technologies for life-threatening conditions in intensive care and cardiac surgery [3] - The company has utilized over 237,000 CytoSorb devices as of March 31, 2024, and has received FDA Emergency Use Authorization for COVID-19 patients [3] - The DrugSorb™-ATR system has received two FDA Breakthrough Device Designations for antithrombotic removal during cardiothoracic procedures [4] Technology and Funding - The purification technologies are based on biocompatible polymer beads that remove toxic substances from blood [5] - CytoSorbents has secured approximately $50 million in funding from various U.S. government agencies, including DARPA and NIH [5] - The company holds numerous patents and has multiple products under development, including ECOS-300CY® and DrugSorb™ [5]

Core Viewpoint - CytoSorbents Corporation has secured a $20 million credit facility to enhance its financial position and support the commercialization of its products, particularly DrugSorb™-ATR, which targets a significant unmet medical need in cardiac surgery [2][4]. Financial Overview - The new credit facility includes an initial term of three years and provides up to $20 million in total term loan capital, with an initial tranche of $15 million [3]. - The facility aims to provide non-dilutive working capital to support the ongoing global CytoSorb® franchise, which generated $32.2 million in trailing 12-month sales as of March 31, 2024 [2]. Product Development and Market Potential - DrugSorb™-ATR, an investigational device, has received FDA Breakthrough Device Designations and aims to reduce serious bleeding complications in patients undergoing coronary artery bypass graft (CABG) surgery [4][8]. - The potential addressable market for DrugSorb-ATR in the U.S. and Canada is estimated to exceed $0.5 billion if approved [4]. Strategic Partnerships - Avenue Capital Group is the financial partner for this credit facility, indicating confidence in CytoSorbents' growth and product development strategies [4][5]. - The partnership is expected to support the international growth of CytoSorb® and other products, particularly in the U.S. and Canadian markets [4]. Technology and Innovation - CytoSorbents' purification technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood, addressing critical medical needs in intensive care and cardiac surgery [6][9]. - The company has received approximately $50 million in non-dilutive funding from various U.S. government agencies to support its innovative technologies [9].

Company Overview - CytoSorbents Corporation is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technology [14][15] - The company's lead product, CytoSorb®, is an extracorporeal cytokine adsorber approved in the European Union and distributed in 75 countries [15] - CytoSorbents has received significant funding, approximately $50 million, from various U.S. government agencies for its purification technologies [10] Financial Partnership - On June 28, 2024, CytoSorbents entered into a $20 million credit facility with Avenue Capital Group to strengthen its financial position and support ongoing initiatives [14] - The credit agreement includes an initial term of three years, providing up to $20 million in total term loan capital, with an initial tranche of $15 million [3] - Proceeds from the facility will support the global CytoSorb® franchise, planned marketing applications for DrugSorb-ATR, and refinancing of existing debt [14] Product Development - DrugSorb-ATR, an investigational device, aims to reduce serious bleeding complications in patients undergoing coronary artery bypass graft surgery while on the blood-thinning drug Brilinta® [1][5] - The company plans to submit marketing applications for DrugSorb-ATR to the U.S. FDA and Health Canada this summer, with a potential addressable market exceeding $0.5 billion if approved [1] - The DrugSorb-ATR has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants during cardiothoracic procedures [5] Market Potential - The anticipated launch of DrugSorb-ATR in the U.S. could significantly impact the market, addressing a major unmet medical need related to bleeding risks in patients on anticoagulants [1][4] - CytoSorbents generated $32.2 million in trailing 12-month sales as of March 31, 2024, indicating a strong market presence [14]