Core Viewpoint - CytoSorbents Corporation has successfully converted its Net Operating Loss (NOL) and R&D tax credits into $1.7 million in cash through the New Jersey Technology Business Tax Certificate Transfer Program, which will bolster its cash reserves and support ongoing growth initiatives [1][2]. Group 1: Financial Impact - The company received $1.7 million in cash proceeds from the sale of its 2023 and amended 2022 NOL and R&D tax credits [1][2]. - This funding is aimed at strengthening cash reserves and supporting strategic initiatives, including the launch of DrugSorb™-ATR in the U.S. and Canada and scaling up manufacturing at its new Princeton facility [2]. Group 2: Tax Credit Program - The New Jersey Technology Business Tax Certificate Transfer Program allows approved technology and biotechnology businesses with NOLs to sell their unused NOLs and R&D tax credits for at least 80% of their value to profitable corporate taxpayers in New Jersey [3]. - The program enables companies to convert tax losses and credits into cash for various expenditures, enhancing their financial flexibility [3]. Group 3: Legislative Context - New Jersey enacted tax reform legislation on July 3, 2023, allowing taxpayers to immediately deduct R&D expenditures retroactively from January 1, 2022, which increased the NOL available for sale in the NJEDA Program for CytoSorbents [4]. Group 4: Company Overview - CytoSorbents Corporation specializes in blood purification technologies for treating life-threatening conditions in intensive care and cardiac surgery [5]. - The company's lead product, CytoSorb®, is approved in the EU and has been used in over 270,000 devices globally, with applications in critical illnesses such as sepsis and liver failure [6]. - CytoSorbents is also developing DrugSorb™-ATR, an investigational device aimed at reducing perioperative bleeding in high-risk surgeries [7].

Ms. Grossman brings 25 years of accomplished finance and accounting experience in global, publicly-traded companies Company announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) PRINCETON, N.J., April 17, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced the appointment of Melanie Grossman, CPA as Vice President and Corporate Controller.  Ms. ...

Core Insights - CytoSorbents Corporation has appointed Thomas Shannon as Vice President of Marketing for North America to lead the marketing strategy for DrugSorb™-ATR in the U.S. and Canada, anticipating marketing approval [1][2] - DrugSorb-ATR is positioned to address perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on the blood thinner Brilinta® [2][3] - The company expects regulatory decisions from the U.S. FDA and Health Canada regarding DrugSorb-ATR in 2025, with the device currently classified as investigational [3][8] Company Overview - CytoSorbents Corporation specializes in blood purification technologies aimed at treating life-threatening conditions in intensive care and cardiac surgery [5][6] - The company's proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, applicable in various medical scenarios including cardiothoracic surgery [5][6] - CytoSorbents' lead product, CytoSorb®, is already approved in the European Union and has been used in over 70 countries, with more than 250,000 devices utilized to date [7] Product Development - DrugSorb-ATR is an investigational device designed to reduce perioperative bleeding severity in high-risk surgeries due to blood thinners, having received two FDA Breakthrough Device Designations [8] - The company submitted a De Novo medical device application to the U.S. FDA for DrugSorb-ATR in September 2024, which is currently under substantive review [8] - CytoSorbents has a range of products under development based on its blood purification technology, protected by numerous patents [9]

Core Viewpoint - CytoSorbents Corporation has extended the expiration date of its Series B Right Warrants from April 10, 2025, to June 10, 2025, allowing more time for warrant holders to exercise their rights [1] Company Overview - CytoSorbents Corporation specializes in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [4] - The company’s proprietary technologies utilize biocompatible, highly porous polymer beads to remove toxic substances from blood and other bodily fluids [4] - CytoSorbents' lead product, CytoSorb®, is approved in the EU and distributed in over 70 countries, with more than 250,000 devices used cumulatively [5] Product and Technology Details - CytoSorb® is designed for applications such as removing blood thinners during cardiothoracic surgery and inflammatory agents in critical illnesses like sepsis and liver failure [4] - The company is developing the DrugSorb™-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received two FDA Breakthrough Device Designations [6] - CytoSorbents holds numerous patents and trademarks for its blood purification technologies, with several products under development [7] Financial and Investment Information - The Series B Right Warrants can be exercised at a price equal to 90% of the 5-day volume weighted average price of the common stock, with a minimum price of $2.00 and a maximum of $4.00 [2] - Approximately 4.8 million shares of common stock are reserved for the exercise of the Series B Right Warrants, which will expire worthless if not exercised [3]

Financial Data and Key Metrics Changes - Product revenue for Q4 2024 was $9.2 million, a 25% increase from $7.3 million in Q4 2023, and total product revenue for the full year reached $35.6 million, representing a 15% year-over-year growth [11][39][47] - Gross margin for Q4 2024 improved to 71%, up from 68% in Q4 2023, reflecting a return to normalized production levels [42][50] - Operating loss for 2024 improved by 47% to $16.7 million compared to $31.9 million in 2023, driven by higher revenue and reduced operating expenses [50] Business Line Data and Key Metrics Changes - CytoSorb, the flagship product, generated $35.6 million in core product sales in 2024, with a 15% growth driven by 28% growth in direct sales outside Germany and 22% growth in distributor and partner sales [9][11] - DrugSorb-ATR is in the regulatory process, with marketing applications submitted to the FDA and Health Canada, expected to drive near-term growth opportunities [10][31] Market Data and Key Metrics Changes - The international market for CytoSorb has shown strong growth, particularly in countries that have secured reimbursement for specific applications, while the German market has faced challenges due to post-COVID issues [11][77] - The total addressable market for DrugSorb-ATR in the U.S. and Canada is projected to grow from $300 million today to over $1 billion as Brilinta becomes generic [30][31] Company Strategy and Development Direction - The company aims to restore sales growth in Germany through a reorganization of the direct sales team and strategy, focusing on deeper customer engagement and improved sales representative productivity [24][52] - The strategy includes a controlled market release of DrugSorb-ATR to gather real-world feedback before a broader launch [32][57] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving near cash flow breakeven by the end of 2025 through revenue growth and cost management [15][45] - The company is optimistic about the potential for DrugSorb-ATR to significantly impact revenue and market presence once regulatory approvals are obtained [31][57] Other Important Information - The company identified misstatements in inventory and stock compensation, leading to restatements of previous financial statements [37][38] - Total cash and cash equivalents as of December 31, 2024, were $9.8 million, with a pro forma cash position of approximately $17 million after the rights offering [15][46] Q&A Session Summary Question: Impact of new U.S. administration on DrugSorb regulatory process - Management indicated that while there has been uncertainty regarding FDA staffing, it has not affected review personnel [61] Question: Key factors for controlled launch of DrugSorb - Management highlighted the importance of understanding hospital integration and surgeon usage patterns during the controlled launch [63][64] Question: Growth drivers for CytoSorb sales outside Germany - Management noted strong growth in international markets due to reimbursement success and increased physician adoption [74][75] Question: Metrics for achieving near cash breakeven - Management stated that continued revenue growth and maintaining gross margins above 70% are essential for reaching breakeven [85] Question: Clarification on DrugSorb revenue assumptions - Management confirmed that the breakeven target excludes DrugSorb revenues, focusing solely on core business performance [89] Question: FDA's potential requests during the review process - Management confirmed ongoing interactive discussions with the FDA, indicating a collaborative review process [96]

Financial Results Announcement - CytoSorbents Corporation announced preliminary and unaudited financial results for the quarter and year ended December 31, 2024[4] - The press release detailing the financial results and business updates was issued on January 3, 2025[4] Regulatory and Filing Information - The financial results are not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934[4] - The press release is furnished as Exhibit 99.1 in the Form 8-K filing[4] Executive Signatory - The report was signed by Dr. Phillip P. Chan, Chief Executive Officer of CytoSorbents Corporation[7]

Financial Performance - Total product revenue for the year ended December 31, 2024, was $35.6 million, an increase of $4.5 million, or 15%, compared to $31.1 million in 2023[252]. - Gross profit for the year ended December 31, 2024, was approximately $25.1 million, an increase of $3.2 million, or 14%, compared to $22.0 million in 2023[256]. - Loss from operations improved by 47% to approximately $16.8 million for the year ended December 31, 2024, down from $31.9 million in 2023, due to revenue growth and a 22% reduction in total operating expenses[260]. - The company experienced a loss on foreign currency transactions of approximately $4.2 million for the year ended December 31, 2024, compared to a gain of approximately $1.9 million in 2023[262]. - The company recorded approximately $3.76 million in stock-based compensation expense for the year ended December 31, 2024, including 1,214,400 performance awards granted[280]. Expenses Management - Research and development expenses decreased by approximately $8.7 million, or 56%, to $6.9 million for the year ended December 31, 2024, primarily due to the completion of the STAR-T clinical trial[257]. - Selling, general and administrative expenses decreased by approximately $3.3 million, or 9%, to $35.0 million for the year ended December 31, 2024, mainly due to reductions in salaries and professional expenses[259]. - The company continues to manage resources proactively, focusing on regulatory submissions and maintaining tight control over expenditures[268]. - The company has adjusted its accounting policy for grants, retroactively reclassifying grant income as a reduction of research and development expenses[279]. Financing Activities - The company secured a $20 million credit facility in June 2024, with an initial tranche of $15 million available at closing[266]. - The company raised a total of $7.3 million through the Rights Offering and Series A Right Warrants, increasing unrestricted cash to $15.6 million as of December 31, 2024, compared to $3.3 million previously reported[270]. - The Rights Offering closed on January 10, 2025, raising gross proceeds of $6.25 million from the sale of 6.25 million Units, each comprising one share of common stock and two Right Warrants[271]. - Approximately 1.4 million Series A Right Warrants were exercised at an exercise price of $1.13 per warrant, generating an additional $1.6 million in gross proceeds[271]. - The Avenue Capital Group has committed to loan the company up to $20 million, with $15 million available in the first tranche and a second tranche of up to $5 million contingent on FDA approval[273]. - The proceeds from the Avenue Capital Commitment will be used to pay off existing debt and for working capital, with interest rates set at a minimum of 5% above the Prime Rate or 13.5%[275]. - The company is actively pursuing various financing sources, including equity and debt financing, to meet its increasing capital needs[272]. Regulatory and Operational Updates - The company submitted a De Novo medical device application for DrugSorb-ATR to the FDA on September 27, 2024, which was accepted for substantive review in October 2024[250]. - The company expects to receive regulatory approval for DrugSorb-ATR in the U.S. and Canada in 2025, which is critical for future capital requirements[272]. - As of December 31, 2024, the company had current assets of approximately $21.6 million and current liabilities of approximately $9.9 million[264]. - The company operates leased facilities in Princeton, New Jersey, and Berlin, Germany, with a monthly base rent of approximately $121,000 as of December 31, 2024[283].

PRINCETON, N.J., March 31, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported financial results for the fourth quarter and full year ended December 31, 2024, and recent business highlights. Fourth Quarter 2024 Financial Results Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, "We delivered a strong fourth quarter, executing on key initi ...

Core Viewpoint - CytoSorbents Corporation reaffirms its preliminary financial results for Q4 and full year 2024, expecting regulatory decisions on DrugSorb™-ATR marketing applications in 2025 [1][4] Financial Results - The company plans to report Q4 and full year 2024 financial results and file its Form 10-K after market close on March 31, 2025 [2] - Estimated Q4 2024 product revenue is projected to be between $9.0 million and $9.2 million, reflecting a growth of 22% to 25% compared to $7.35 million in Q4 2023 [8] - Full-year product revenue is expected to be between $35.4 million and $35.6 million, indicating approximately 14% growth from $31.1 million in 2023 [8] - The estimated cash balance as of December 31, 2024, is approximately $17.0 million, including $15.5 million in unrestricted cash, after accounting for recent fundraising activities [5] DrugSorb-ATR Marketing Applications - The marketing applications for DrugSorb-ATR are under substantive review by the U.S. FDA and Health Canada, with decisions anticipated in 2025 [4][11] - DrugSorb-ATR is designed to reduce perioperative bleeding in high-risk surgeries and has received two FDA Breakthrough Device Designations [11] Conference Call Details - A live conference call and presentation will be held on March 31, 2025, at 4:30 PM ET, with details provided for participants to join [7]

Core Viewpoint - CytoSorbents Corporation reaffirms its preliminary financial results for the quarter and full year ended December 31, 2024, and anticipates regulatory decisions on DrugSorb™-ATR marketing applications in 2025 [1][6] Financial Results - The company expects to report fourth quarter and full year 2024 financial results after market close on March 25, 2025, with a live conference call scheduled for the same day [2] - Fourth quarter product revenue is projected to be between $9.0 million and $9.2 million, reflecting a growth of 22% to 25% compared to $7.35 million in the fourth quarter of 2023 [9] - Full-year product revenue is estimated to be between $35.4 million and $35.6 million, indicating approximately 14% growth from $31.1 million in 2023 [9] - The estimated cash balance as of December 31, 2024, is approximately $17.0 million, including unrestricted cash of about $15.5 million, following a net cash burn of approximately $2.5 million in Q4 2024 [7][8] Leadership and Transition - The postponement of the earnings call is due to the unexpected passing of the company's Vice President and Corporate Controller, James E. Cason, Jr., who had been with the company for 10 years [3][4] - The CEO expressed condolences and emphasized the strength of the financial team to ensure a smooth transition of responsibilities during this period [4] DrugSorb-ATR Development - The marketing applications for DrugSorb-ATR are under substantive review by the U.S. FDA and Health Canada, with regulatory decisions expected in 2025 [6][12] - DrugSorb-ATR is designed to reduce perioperative bleeding in high-risk surgeries and has received two FDA Breakthrough Device Designations [12]