Core Insights - CytoSorbents Corporation has opened a new regional sales subsidiary in Dubai, UAE, marking a significant step in its expansion strategy into the Middle East and Africa [1][2] - The new subsidiary aims to enhance sales growth, support existing partnerships, and foster new alliances in a region with increasing demand for advanced medical technologies [2][3] Company Overview - CytoSorbents is a leader in treating life-threatening conditions in intensive care and cardiac surgery through blood purification technologies [3][4] - The company's proprietary technology utilizes biocompatible polymer beads to remove toxic substances from blood, with applications in various critical illnesses [3][4] Product Information - The lead product, CytoSorb, is approved in the European Union and distributed in 76 countries, with over 250,000 devices used to date [4] - CytoSorb has received FDA Emergency Use Authorization for critically ill COVID-19 patients in the U.S. but is not yet fully approved [4] Development Initiatives - CytoSorbents is developing the DrugSorb-ATR system to reduce perioperative bleeding in high-risk surgeries, which has received FDA Breakthrough Device Designations [5][6] - The company has submitted a De Novo medical device application to the U.S. FDA for marketing approval of DrugSorb-ATR [6] Strategic Location - The new commercial office is located in Dubai's Science Park, a healthcare-focused free zone, chosen for its strategic location and favorable economic conditions [2][3]

Core Insights - CytoSorbents Corporation reported preliminary fourth quarter product revenue growth estimated at 22% to 25% year-over-year, with gross margin expected to improve to approximately 70% [1][7] - The company is preparing to enter the North American market with its investigational product DrugSorb-ATR, pending FDA and Health Canada approvals [4][10] Financial Performance - Fourth quarter product revenue (excluding grant income) is estimated to be between $9.0 million and $9.2 million, compared to $7.35 million in the fourth quarter of 2023, reflecting a growth of approximately 22% to 25% [7] - Full-year product revenue (excluding grant income) is estimated to be in the range of $35.4 million to $35.6 million, representing about 14% growth from $31.1 million in 2023 [7] - Fourth quarter product gross margin is estimated at approximately 70%, an improvement from 61% in the prior quarter and 72% in the fourth quarter of 2023 [7] Business Updates - The company will host in-person investor meetings during the J.P. Morgan Healthcare Conference in San Francisco from January 13-16, 2025 [5] - CytoSorbents is developing DrugSorb-ATR, an investigational device aimed at reducing perioperative bleeding in patients on Brilinta during CABG surgery, with regulatory reviews currently underway [7][10] - The company commenced a rights offering on December 23, 2024, with a subscription period ending on January 10, 2025 [7] Product Information - CytoSorb, the company's flagship product, is approved in the European Union and distributed in 76 countries, with over a quarter million devices used cumulatively [9] - The company has received FDA Emergency Use Authorization for CytoSorb for critically ill COVID-19 patients [9] - DrugSorb-ATR has received two FDA Breakthrough Device Designations for the removal of ticagrelor and direct oral anticoagulants during urgent cardiothoracic procedures [10]

Rights Offering Details - CytoSorbents Corporation announces the commencement of its Rights Offering, with stockholders and certain warrantholders of record on December 16, 2024, receiving one non-transferable Subscription Right Warrant per share of common stock owned [1] - Each Subscription Right allows the purchase of one Unit at a subscription price of $1 00 per Unit, with each Unit consisting of one share of common stock and two transferable short-term Right Warrants to purchase up to two additional shares of common stock at discounted prices [2] - The Subscription Rights must be exercised before the expiration date of 5 00 PM EST on January 10, 2025, and investors can exercise all, some, or none of their Subscription Rights through online or hard copy documentation or by contacting their broker or banking representative [2] - Investors who exercise all of their basic subscription rights may participate in an oversubscription of unsubscribed Subscription Rights, if available, and must elect this option at the time of their subscription rights exercise [2] - Upon completion of the subscription period on January 10, 2025, participating stockholders who purchased Units will receive the associated shares of common stock and Right Warrants to their brokerage account, subject to pro-rata adjustment if the Rights Offering is oversubscribed [2] Company Overview - CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification, utilizing proprietary blood purification technologies based on biocompatible, highly porous polymer beads [7] - The company's technologies are used in broad applications, including the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding and the removal of inflammatory agents in critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis [7] - CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in 76 countries worldwide, with over a quarter million devices used cumulatively to date [8] - CytoSorb has received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels, but is not yet approved in the United States [8] - In the U S and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, which has received two FDA Breakthrough Device Designations and is under review for marketing approval in the U S and Canada [9] Additional Information - The Rights Offering is being made pursuant to CytoSorbents' effective shelf registration statement on Form S-3 and a related prospectus supplement filed with the SEC [5] - A short presentation on the Rights Offering has been filed with the SEC as a free writing prospectus and can be found on the company's investor relations website [4] - Moody Capital Solutions, Inc is the dealer manager for the offering, and any interested broker-dealers may contact Moody at info@moodycapital com [4] - For any questions or further information about the Rights Offering, investors can contact D F King & Co , Inc , the information agent for the offering, at (800) 549-6864 or (212) 269-5550, or email CTSO@dfking com [3]

Core Insights - CytoSorbents Corporation and Converge Biotech have formed a strategic collaboration to enhance their market presence in the sepsis and critical care sectors in India [1][3] - The partnership aims to leverage CytoSorbents' blood purification technology, CytoSorb®, to improve patient outcomes in critical care settings across India [2][4] Company Overview - CytoSorbents is recognized for its flagship product, CytoSorb®, which is designed to mitigate "cytokine storm" and remove inflammatory toxins, addressing critical illnesses prevalent in India such as sepsis and septic shock [2][5] - CytoSorb is utilized in 76 countries, with over 250,000 treatments administered globally [2][7] - Converge Biotech specializes in critical care and has a robust sales force and hospital network in India, aiming to accelerate the market penetration of CytoSorb [3][5] Strategic Collaboration - The collaboration will enable Converge Biotech to integrate CytoSorb into its existing ICU portfolio, enhancing the treatment options available for life-threatening diseases [3][4] - Both companies anticipate that this partnership will drive growth and improve access to life-saving therapies in one of the fastest-growing critical care markets globally [4][5] Product Applications - CytoSorbents' technology is applicable in various critical conditions, including the removal of blood thinners during surgery and the treatment of severe inflammatory responses in diseases like sepsis and liver failure [5][6] - The product has received regulatory approvals in the European Union and has been granted Emergency Use Authorization by the FDA for use in critically ill COVID-19 patients [7][8]

Financial Data and Key Metrics - Q3 2024 product sales were $8.6 million, exceeding the guided range of $8.3 million to $8.5 million, representing an 11% YoY growth [12] - Product gross margins were 61% for the quarter, above the guided range of 50% to 60%, but down from 71% YoY due to a planned production slowdown and a short-term manufacturing issue [13] - Operating expenses decreased 25% YoY, leading to a 40% reduction in operating loss and lowering cash burn to $2.7 million compared to $5 million in Q2 2024 [14] - Adjusted EBITDA loss improved to $3.5 million from $5.6 million in the prior year, driven by reduced operating expenses [41] - Net loss for the quarter was $2.3 million compared to $9.2 million in the prior year [41] Business Line Performance - CytoSorb, the flagship product, generated $34 million in trailing 12-month sales, with over 0.25 million devices used cumulatively across 76 countries [9] - DrugSorb ATR, an investigational device, has received FDA breakthrough device designation and is under regulatory review in the U.S. and Canada, with decisions expected in 2025 [10][22] - The PuriFi hemoperfusion pump, launched last quarter, has received positive feedback and is expected to drive increased demand for CytoSorb cartridges [33] Market Performance - CytoSorb sales showed strength in international direct sales channels, particularly in Germany, and growing interest in distributor-served geographies [12] - Brilinta, the blood thinner targeted by DrugSorb ATR, enjoys a dominant market share in Canada and a growing 50% share in the U.S. for acute coronary syndrome treatment [17] Strategic Direction and Industry Competition - The company is focused on expanding its international critical care and cardiac surgery business, improving operational efficiencies, and preparing for the potential launch of DrugSorb ATR in North America [34] - DrugSorb ATR has the potential to address a $300 million TAM initially, which could grow to over $1 billion with label expansion to other blood thinner categories [30] - The company is leveraging its manufacturing and commercialization experience from international markets for the expected North American launch [30] Management Commentary on Operating Environment and Future Outlook - Management highlighted the progress in regulatory submissions for DrugSorb ATR and the potential to transform the standard of care for patients with acute coronary syndromes [27][29] - The company expects to return to normalized production levels and product gross margins in Q4 2024 [13] - Management is optimistic about the future growth opportunities, particularly with the potential FDA and Health Canada approvals in 2025 [34] Other Important Information - The company received MDSAP certification, a significant regulatory milestone, enabling compliance with quality management standards in multiple countries, including the U.S. and Canada [23] - The STAR-T trial data showed a favorable benefit-to-risk profile for DrugSorb ATR in patients undergoing CABG surgery within 2 days of Brilinta discontinuation [19][25] - The company has $12.2 million in cash, including $6.5 million in restricted cash, and access to additional milestone-based liquidity through a loan agreement [42][43] Q&A Session Summary Question: FDA submission review process - The FDA review process for DrugSorb ATR is ongoing, with a decision expected in 2025. The company is eligible for priority review due to its breakthrough device designation, which may expedite the process [46][47] Question: Taiwan launch update - Regulatory approval in Taiwan was recently obtained, and the company anticipates accelerated market entry in the coming year [48] Question: Loan proceeds and restricted cash - The $5 million in restricted cash will be released upon FDA acceptance of the marketing application and raising $5 million in new equity, potentially unlocking $10 million in liquidity [49] Question: PuriFi pump program - The PuriFi pump is designed to expand CytoSorb usage globally, particularly in regions without dialysis infrastructure. It is currently in trial phases and has received positive feedback [51][54] Question: Gross margin normalization - The company expects to return to normalized gross margins in Q4 2024, with a long-term goal of achieving 75% to 80% margins for CytoSorb [56][57]

Revenue and Sales Performance - Total revenues for Q3 2024 were $9.39 million, a 7% increase compared to $8.81 million in Q3 2023[123] - Product sales increased by 11% to $8.61 million in Q3 2024, driven by a 21% increase in direct sales[123] - Total revenues increased by 5% to $29,071,000 for the nine months ended September 30, 2024, with product sales up 11% to $26,444,000, driven by a 16% increase in distributor sales and an 8% increase in direct sales[133] Grant Income - Grant income decreased by 26% to $777,000 in Q3 2024 due to the completion of several grants in 2023[124] - Grant income decreased by 33% to $2,627,000 for the nine months ended September 30, 2024, due to the completion of several grants in 2023[134] Gross Profit and Margins - Gross profit decreased to $5.28 million in Q3 2024 from $5.61 million in Q3 2023, with product gross margins dropping to 61% from 72%[126] - Gross profit increased by $1,274,000 to $18,355,000 for the nine months ended September 30, 2024, despite a temporary production slowdown and manufacturing issues that reduced CytoSorb device output[135] - Inflationary pressures have increased labor and raw material costs, impacting product gross margins[122] Research and Development Expenses - Research and development expenses decreased by 51% to $1.85 million in Q3 2024, primarily due to the completion of the STAR-T clinical trial[127] - Research and development expenses decreased by 52% to $5,619,000 for the nine months ended September 30, 2024, primarily due to the completion of the STAR-T clinical trial in December 2023[136] Product and Market Performance - CytoSorb® has been used in over 250,000 devices cumulatively and is distributed in 76 countries worldwide[115] - The DrugSorb™-ATR system received FDA Breakthrough Device Designations and a De Novo application was submitted in September 2024[116] - The STAR-T clinical trial demonstrated reduced perioperative bleeding in CABG surgery patients, representing over 90% of the study population[119] Government-Funded Projects - The company has ongoing government-funded projects totaling $15.8 million, $4.7 million, and $7.7 million for HemoDefend-BGA™, HemoDefend-RBC™, and K+ontrol™, respectively[121] Selling, General, and Administrative Expenses - Selling, general and administrative expenses decreased by $1,101,000 (14%) to $7,003,000 for the three months ended September 30, 2024, primarily due to reductions in non-cash stock compensation, salaries, and royalty expenses[129] Interest Expense and Debt - Interest expense, net increased to $588,000 for the three months ended September 30, 2024, compared to $34,000 in the same period in 2023, driven by new debt from Avenue Capital Group with a principal of $15,000,000 and an interest rate of 13.5%[130] - Interest expense, net increased to $775,000 for the nine months ended September 30, 2024, compared to $106,000 in 2023, due to the Avenue Capital Group debt facility[139] - The company closed a $20 million term-loan facility with Avenue Capital Group in June 2024, with $15 million initially disbursed and $5 million contingent on FDA approval of DrugSorb-ATR[143] Foreign Currency Transactions - Gain on foreign currency transactions was $2,650,000 for the three months ended September 30, 2024, compared to a loss of $1,810,000 in 2023, due to the Euro strengthening against the U.S. dollar from $1.07 to $1.11[131] Cash and Liquidity - As of September 30, 2024, the company had $12.2 million in cash, including $5.7 million unrestricted and $6.5 million restricted, with additional funds contingent on achieving milestones related to FDA approval and equity financing[145] - As of September 30, 2024, the company's cash, cash equivalents, and restricted cash balances were approximately $12.2 million, including $5.7 million in cash and cash equivalents and $6.5 million in restricted cash, raising substantial doubt about its ability to continue as a going concern[150] - The company is pursuing milestones related to its Avenue Capital Group debt facility, which could increase its unrestricted cash position by up to $10 million, and is evaluating other capital sources, including debt financing, equity financing, and strategic investments[150] Leasing and Facilities - CytoSorbents Europe GmbH leased an additional 1,068 square meters of warehouse space starting April 1, 2021, with monthly base rent of $7,784 and other costs of approximately $239, for a term of five years with an option to extend for another five years[147] - The company extended two operating leases for its office facility in Germany in September 2021, requiring combined base rent payments of approximately $12,100 per month and monthly operating expenses of approximately $3,000, with a five-year renewal option extending the lease term to August 31, 2031[148]

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 ...