Financial Data and Key Metrics Changes - Total revenue for 2023 was approximately $36.3 million, an increase of about $1.6 million or 5% compared to $34.7 million in 2022 [58] - CytoSorb product sales were $31 million in 2023, up from $28.6 million in 2022, representing a 9% increase [34] - Product gross margin improved to 72% in 2023 from 70% in 2022, with expectations for further improvement in 2024 [15] Business Line Data and Key Metrics Changes - Core CytoSorb sales grew 10% year-over-year, with distributor partner sales in the first three quarters of 2024 growing 18% compared to the same period in 2022 [27][28] - CytoSorb product sales for Q4 2023 were $7.3 million, a slight decrease of 1% from $7.4 million in Q4 2022 [36] - Grant revenue for 2023 was $5.3 million, approximately the same as in 2022 [15] Market Data and Key Metrics Changes - Direct sales in Germany grew 3%, while the market is expected to improve in 2024 despite post-pandemic challenges [54] - The company has a presence in 75 countries, with significant sales growth in international direct markets, accounting for 19% of product sales for the year [53] - The company anticipates a potential doubling of the total addressable market in the U.S. and Canada due to the expected market share growth of Brilinta [26] Company Strategy and Development Direction - The company is focusing on the launch of its standalone hemoperfusion pump, PuriFi, expected later this year [22] - CytoSorb is positioned as a high-margin medical device with a strong foundation, aiming to leverage its growth initiatives alongside the anticipated approval of DrugSorb-ATR [40] - The company is actively pursuing various funding sources to support ongoing operations and future growth [62] Management's Comments on Operating Environment and Future Outlook - Management noted a stabilization in mature markets like Germany, with expectations for growth in other direct and distributor markets [45] - The company is optimistic about the potential for growth driven by macro trends in healthcare, including an aging population and the increasing use of blood thinners [63] - Management highlighted the importance of cash conservation and cost-cutting measures to improve financial stability [62] Other Important Information - The STAR-T trial results are expected to be presented at the AATS conference in late April, with data released live during the conference [42] - The company has received over $50 million in grants and contracts from the U.S. government to support its technology [30] - The company is developing HemoDefend-BGA, a universal plasma product, with significant funding from the U.S. Department of Defense [13] Q&A Session Summary Question: Timeline for data release related to the STAR-T trial - Management confirmed that data will be released live during the ATS conference in Toronto, not ahead of that [42] Question: Insights on the India distribution agreement - The company has a temporary agreement with ARRIS, which has been retraining employees from Biocon to ensure a smooth transition [50][81] Question: Impact of sales channel changes - Management indicated that the sales distribution from direct and distributor markets is expected to stabilize and grow, similar to past performance in Germany [69] Question: Current share count - The company reported 54.2 million common shares outstanding, with a fully diluted count of 67.9 million [88]

STAR-T trial results selected for a Breakout Presentation at the American Association of Thoracic Surgery Annual Meeting in late-April 2024 CytoSorbents intends to submit DrugSorb-ATR for regulatory approval to U.S. Food & Drug Administration (FDA) and Health Canada this year CytoSorb core sales increased approximately 10% year-over-year   2023 Product gross margins increased to 72%   Cumulative CytoSorb treatments surpassed 228,000 PRINCETON, N.J., March 14, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporatio ...

We believe that there are no compliance issues associated with applicable environmental laws and regulations that would have a material adverse effect on us or our business. We incur waste removal costs in connection with both our solid and liquid wastes which are byproducts of our manufacturing process. We utilize the services of various qualified contractors to dispose of these waste products. These waste removal costs amounted to approximately $470,000 for the year ended December 31, 2023. As of March 7, ...

Exhibit 99.1 CytoSorbents Reports Fourth Quarter and Full Year 2023 Results PRINCETON, N.J., March 14, 2024 — 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, today reported financial and operating results for the quarter and year ended December 31, 2023 and provides its 2024 outlook. Full Year 2023 Financial Results · STAR-T trial result ...

PRINCETON, N.J., Feb. 08, 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, announces that Dr. Phillip Chan, Chief Executive Officer, will present at the TD Cowen 44th Annual Health Care Conference at the Boston Marriott Copley Place, in Boston, MA on Wednesday, March 6th, 2024. Company management will also meet in-person with investors in 1x1 meetings during the c ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $8.8 million, an increase of approximately 9% from $8.1 million in Q3 2022 [49] - Product sales for Q3 2023 were $7.8 million, up approximately 20% from $6.5 million in Q3 2022 [22] - Gross margins for Q3 2023 improved to 72% compared to 55% in Q3 2022 [22] - For the nine months ended September 30, 2023, total revenue was $27.7 million, a 9% increase over $25.3 million in the same period of 2022 [23] Business Line Data and Key Metrics Changes - Core product sales for the trailing 12 months ended September 30, 2023, were $31.4 million, slightly higher than $29.4 million in the prior year [51] - Grant revenue for the first nine months of 2023 was $3.9 million, compared to $3.6 million in the same period of 2022 [23] Market Data and Key Metrics Changes - CytoSorb has been used in over 221,000 human treatments across 75 countries, with total sales exceeding $205 million to date [8][10] - The company has expanded its ANVISA registration of CytoSorb to treat shock in Brazil, which is a significant market opportunity [10] Company Strategy and Development Direction - The company aims to commercialize DrugSorb-ART in the US and Canada, targeting a total addressable market of approximately $650 million [9][28] - The partnership with Fresenius Medical Care is expected to enhance sales and marketing efforts for CytoSorb, leveraging their extensive platform [20][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the STAR-T trial's potential to support FDA approval, with data analysis expected before year-end [14][28] - The company is focused on maintaining tight cash controls and identifying cost reduction opportunities, with a current cash position of approximately $10 million [25][26] Other Important Information - The average quarterly burn rate for 2023 has decreased significantly to approximately $4.6 million from $9.9 million in the same period of 2022 [25] - The company is exploring various capital-raising options, including less dilutive financing methods [53] Q&A Session Summary Question: Update on the STAR-T trial analysis timeline - Management indicated that the database lock is nearing completion, and they expect to provide initial data assessment by year-end [59][80] Question: Status of the European ICU bed market, particularly in Germany - Management noted that ICU bed availability has improved compared to COVID-19 levels, contributing to a recovery in German sales [63] Question: Expected quarterly burn rate in the upcoming quarters - The burn rate is expected to remain similar in the fourth quarter, with potential reductions beginning in 2024 as cost containment measures take effect [64] Question: Plans for commercialization in the US - Preparations are underway for manufacturing and compliance with FDA requirements, with a focus on building infrastructure for DrugSorb-ART [92] Question: Reimbursement strategies for DrugSorb - Management discussed potential reimbursement through DRG and the TCET program, emphasizing the importance of reducing costs associated with patient care [109]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, highlighting a going concern issue due to insufficient cash for future operations - The Company's cash and cash equivalents of approximately **$10.0 million** as of September 30, 2023, are not expected to fund operations beyond the next twelve months, raising substantial doubt about its ability to continue as a going concern[21](index=21&type=chunk) [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights (Unaudited) | Metric | September 30, 2023 ($) | December 31, 2022 ($) | | :-------------------------------- | :------------------- | :------------------ | | Cash and cash equivalents | 8,359,047 | 22,144,567 | | Total current assets | 19,260,643 | 33,759,691 | | Total Assets | 47,575,037 | 63,231,530 | | Total current liabilities | 11,972,396 | 9,714,552 | | Total Liabilities | 29,063,415 | 27,856,557 | | Total Stockholders' Equity | 18,511,622 | 35,374,973 | [Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Consolidated Statements of Operations and Comprehensive Loss Highlights (Unaudited) | Metric (Three months ended Sep 30) | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :--------------------------------- | :------------ | :------------ | :------------ | :--------- | | Total revenue | 8,810,847 | 8,111,353 | 699,494 | 8.6% | | Gross margin | 5,606,866 | 3,617,377 | 1,989,489 | 55.0% | | Loss from operations | (7,350,198) | (9,017,338) | 1,667,140 | -18.5% | | Net loss | (9,193,520) | (12,200,837) | 3,007,317 | -24.6% | | Basic and diluted net loss per share | (0.21) | (0.28) | 0.07 | -25.0% | | Metric (Nine months ended Sep 30) | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :-------------------------------- | :------------ | :------------ | :------------ | :--------- | | Total revenue | 27,681,164 | 25,298,335 | 2,382,829 | 9.4% | | Gross margin | 17,080,743 | 14,976,020 | 2,104,723 | 14.1% | | Loss from operations | (21,867,828) | (25,165,524) | 3,297,696 | -13.1% | | Net loss | (22,672,487) | (32,046,457) | 9,373,970 | -29.2% | | Basic and diluted net loss per share | (0.52) | (0.74) | 0.22 | -29.7% | [Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Changes in Stockholders' Equity (Nine months ended Sep 30, 2023) | Item | Amount ($) | | :--------------------------------------- | :----------- | | Balance at December 31, 2022 | 35,374,973 | | Stock-based compensation | 2,486,679 | | Foreign translation adjustment | 654,792 | | Issuance of common stock offerings, net | 2,107,119 | | Proceeds from exercise of stock options | 213,307 | | Issuance of restricted stock units | 403,941 | | Legal/audit fees related to ATM offering | (56,702) | | Net loss | (22,672,487) | | Balance at September 30, 2023 | 18,511,622 | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Highlights (Nine months ended Sep 30) | Cash Flow Activity | 2023 ($) | 2022 ($) | | :----------------- | :------------ | :------------ | | Operating | (15,247,725) | (22,893,955) | | Investing | (800,314) | (6,249,496) | | Financing | 2,263,724 | (40,359) | | Net change in cash | (13,785,520) | (29,585,468) | [Notes to Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) [1. BASIS OF PRESENTATION](index=7&type=section&id=1.%20BASIS%20OF%20PRESENTATION) This section outlines the basis for preparing interim financial statements, noting a going concern issue due to insufficient cash - The interim consolidated financial statements are prepared in conformity with U.S. GAAP and include normal recurring adjustments, with the Company's cash position raising substantial doubt about its ability to continue as a going concern, necessitating additional capital[20](index=20&type=chunk)[21](index=21&type=chunk) [2. PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=7&type=section&id=2.%20PRINCIPAL%20BUSINESS%20ACTIVITY%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This section details the Company's core business, product commercialization, strategic agreements, and significant accounting policies for various financial metrics - CytoSorbents Corporation specializes in blood purification for life-threatening conditions, with its flagship product CytoSorb approved in the EU and marketed in over **75** countries, and has expanded direct sales to India, France, and the UK, also receiving FDA Breakthrough Device Designations for DrugSorb-ATR[22](index=22&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - The distribution agreement with Nikkiso Europe GmbH expired in September 2023, and the Company is seeking a new supplier for a stand-alone hemoperfusion pump[29](index=29&type=chunk) - A Marketing Agreement with Fresenius Medical Care Deutschland GmbH aims to strengthen global marketing of CytoSorb, with a program launch expected in 2024[30](index=30&type=chunk)[32](index=32&type=chunk) Cash, Cash Equivalents and Restricted Cash | Category | September 30, 2023 ($) | December 31, 2022 ($) | | :-------------------------------- | :------------------- | :------------------ | | Cash and cash equivalents | 8,359,047 | 22,144,567 | | Restricted cash | 1,687,459 | 1,687,459 | | Total cash, cash equivalents and restricted cash | 10,046,506 | 23,832,026 | - The allowance for doubtful accounts decreased from approximately **$76,000** at December 31, 2022, to **$57,000** at September 30, 2023[40](index=40&type=chunk) - The Company recorded impairment charges of approximately **$183,000** and **$476,000** for the three and nine months ended September 30, 2023, respectively, related to certain patent costs[44](index=44&type=chunk) - Advertising expenses decreased significantly, from **$143,000** to **$49,000** for the three months ended September 30, 2023, and from **$358,000** to **$143,000** for the nine months ended September 30, 2023[48](index=48&type=chunk) - Freight costs increased from **$79,000** to **$140,000** for the three months ended September 30, 2023, and from **$166,000** to **$341,000** for the nine months ended September 30, 2023[59](index=59&type=chunk) [3. STOCKHOLDERS' EQUITY](index=18&type=section&id=3.%20STOCKHOLDERS'%20EQUITY) This section details changes in stockholders' equity, including authorized shares, common stock offerings, stock-based compensation, and stock option activity - The Company's certificate of incorporation authorizes **5,000,000** shares of preferred stock and **100,000,000** shares of common stock[63](index=63&type=chunk)[64](index=64&type=chunk) - Under an Open Market Sale Agreement with Jefferies LLC, the Company sold **590,348** shares for net proceeds of approximately **$2,107,000** during the nine months ended September 30, 2023[67](index=67&type=chunk) Stock-Based Compensation Expense | Period | 2023 ($) | 2022 ($) | | :----------------------------------- | :---------- | :---------- | | Three months ended September 30 | 1,086,000 | 1,005,000 | | Nine months ended September 30 | 2,487,000 | 2,554,000 | Stock Option Activity (Nine months ended Sep 30, 2023) | Activity | Shares | Weighted Average Exercise Price per Share ($) | | :----------------------- | :---------- | :-------------------------------------------- | | Outstanding, Dec 31, 2022| 9,474,824 | 4.66 | | Granted | 2,583,880 | 3.45 | | Forfeited | (748,381) | 2.96 | | Expired | (435,781) | 5.10 | | Exercised | (84,093) | 2.61 | | Outstanding, Sep 30, 2023| 10,790,449 | 4.48 | - As of September 30, 2023, the Company had approximately **$7,990,000** of total unrecognized compensation cost related to stock options, to be amortized over approximately **41 months**[71](index=71&type=chunk) - Restricted stock units granted to Board members, executive officers, and employees will only vest upon a Change in Control of the Company, with no charge recorded due to vesting uncertainty[82](index=82&type=chunk) [4. REVENUE](index=23&type=section&id=4.%20REVENUE) This section disaggregates revenue by customer type and geographic area, detailing product sales and grant income, and notes changes in contract receivables Revenue Disaggregation by Customer Type and Geographic Area (Three months ended Sep 30, 2023) | Category / Region | Direct Sales ($) | Distributors/Strategic Partners ($) | Government Agencies ($) | Total ($) | | :---------------- | :--------------- | :---------------------------------- | :---------------------- | :----------- | | Product sales: | | | | | | United States | 44,933 | — | — | 44,933 | | Germany | 2,937,431 | — | — | 2,937,431 | | All other countries | 1,267,051 | 3,504,601 | — | 4,771,652 | | Total product revenue | 4,249,415 | 3,504,601 | — | 7,754,016 | | Grant and other income: | | | | | | United States | — | — | 1,056,831 | 1,056,831 | | Total revenue | 4,249,415 | 3,504,601 | 1,056,831 | 8,810,847 | Revenue Disaggregation by Customer Type and Geographic Area (Nine months ended Sep 30, 2023) | Category / Region | Direct Sales ($) | Distributors/Strategic Partners ($) | Government Agencies ($) | Total ($) | | :---------------- | :--------------- | :---------------------------------- | :---------------------- | :----------- | | Product sales: | | | | | | United States | 55,284 | — | — | 55,284 | | Germany | 9,443,787 | — | — | 9,443,787 | | All other countries | 4,263,375 | 9,974,022 | — | 14,237,397 | | Total product revenue | 13,762,446 | 9,974,022 | — | 23,736,468 | | Grant and other income: | | | | | | United States | — | — | 3,944,696 | 3,944,696 | | Total revenue | 13,762,446 | 9,974,022 | 3,944,696 | 27,681,164 | - The Company's two primary revenue streams are CytoSorb device sales (direct and distributor) and grant income from U.S. government agencies[91](index=91&type=chunk) - Contract receivables from product sales to distributors increased from **$2,944,031** at December 31, 2022, to **$4,122,442** at September 30, 2023[97](index=97&type=chunk) [5. LONG-TERM DEBT, NET](index=28&type=section&id=5.%20LONG-TERM%20DEBT,%20NET) This section details the Company's long-term debt, including a term loan facility, interest-only payment terms, and future principal payment obligations - The Company has a **$15 million** term loan facility with Bridge Bank, with the first **$5 million** tranche drawn in December 2022, and no further draws available as of the filing date[99](index=99&type=chunk)[100](index=100&type=chunk) - Interest-only payments are required through December 2023, with potential extension through June 2024 if certain financial tests are met, and principal payments begin January 2024 or July 2024, depending on these tests[100](index=100&type=chunk) Long-term Debt as of September 30, 2023 | Item | Amount ($) | | :------------------------ | :--------- | | Principal amount | 5,000,000 | | Accrued final fee | 32,143 | | Subtotal | 5,032,143 | | Less current maturities | (833,333) | | Long-term debt net of current maturities | 4,198,810 | Principal Payments of Long-term Debt | Period ending September 30 | Amount ($) | | :------------------------- | :--------- | | 2024 | 833,333 | | 2025 | 3,333,334 | | 2026 | 833,333 | | Total | 5,000,000 | [6. COMMITMENTS AND CONTINGENCIES](index=31&type=section&id=6.%20COMMITMENTS%20AND%20CONTINGENCIES) This section covers key personnel changes, the settlement of a litigation matter, and details on royalty and licensing expenses - Kathleen P. Bloch was re-appointed as Chief Financial Officer effective September 18, 2023, replacing Alexander D'Amico whose employment was mutually terminated[108](index=108&type=chunk)[109](index=109&type=chunk) - The Company settled a litigation matter for **$280,000**, which is included in accrued expenses and other current liabilities[110](index=110&type=chunk)[196](index=196&type=chunk) Royalty Expenses | Period | 2023 ($) | 2022 ($) | | :----------------------------------- | :------- | :------- | | Three months ended September 30 | 229,000 | 187,000 | | Nine months ended September 30 | 703,000 | 627,000 | Licensing Expenses | Period | 2023 ($) | 2022 ($) | | :----------------------------------- | :------- | :------- | | Three months ended September 30 | 308,000 | 312,000 | | Nine months ended September 30 | 940,000 | 1,046,000| [7. LEASES](index=34&type=section&id=7.%20LEASES) This section details the Company's operating lease agreements for facilities in the U.S. and Germany, including right-of-use assets, lease liabilities, and associated cash flows - The Company leases operating facilities in the United States (Princeton, NJ) and Germany, with the Princeton lease commencing June 1, 2021, for **15.5 years** and annual base rent increases of approximately **2.75%**[116](index=116&type=chunk) Right-of-Use Asset and Lease Liability | Item | September 30, 2023 ($) | December 31, 2022 ($) | | :------------------------ | :------------------- | :------------------ | | Right-of-use asset | 12,196,049 | 12,603,901 | | Total lease liability | 13,009,413 | 13,250,944 | | Less current portion | (117,204) | (108,939) | | Lease liability, net of current portion | 12,892,209 | 13,142,005 | - Operating cash flows paid for leases amounted to approximately **$633,000** and **$1,801,000** for the three and nine months ended September 30, 2023, respectively[120](index=120&type=chunk) [8. NET LOSS PER SHARE](index=36&type=section&id=8.%20NET%20LOSS%20PER%20SHARE) This section explains the computation of net loss per share, noting the exclusion of anti-dilutive outstanding options and restricted stock awards - All outstanding options and restricted stock awards, representing approximately **14,119,000** incremental shares at September 30, 2023, were excluded from diluted loss per share computation as they were anti-dilutive[123](index=123&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Company's financial condition and operational results, covering product developments, clinical trials, sales strategies, and liquidity challenges, including a going concern warning [Overview](index=37&type=section&id=Overview) This overview highlights CytoSorbents' leadership in blood purification, its key strategic objectives, and its robust intellectual property portfolio - CytoSorbents is a leader in blood purification for life-threatening conditions, with its flagship product, CytoSorb, commercialized globally and used in over **221,000** human treatments[129](index=129&type=chunk)[130](index=130&type=chunk) - Key objectives include obtaining FDA marketing approval for DrugSorb-ATR in the U.S., growing core CytoSorb sales to profitability, and reducing cash burn[131](index=131&type=chunk)[132](index=132&type=chunk) - The Company's technology is protected by **19** issued U.S. patents and multiple international patents, with several product candidates under development[131](index=131&type=chunk)[133](index=133&type=chunk) [Clinical Studies Update](index=40&type=section&id=Clinical%20Studies%20Update) This section provides updates on key clinical trials, including the completed STAR-T trial, paused STAR-D trial, and positive results from the U.S. CTC Registry - The pivotal STAR-T trial for DrugSorb-ATR completed patient enrollment in July 2023 and final patient follow-up in August 2023, with initial data analysis expected before year-end to support FDA marketing approval[136](index=136&type=chunk) - Enrollment in the STAR-D trial for Direct Oral Anticoagulants (DOACs) was paused in November 2022 and is expected to resume after STAR-T trial activities conclude[137](index=137&type=chunk) - The U.S. CTC (CytoSorb Therapy in COVID-19) Registry completed enrollment with **100** patients, showing high **90-day survival (74%)** in critically ill COVID-19 patients treated with CytoSorb and ECMO[140](index=140&type=chunk) [Sales and Marketing Update](index=42&type=section&id=Sales%20and%20Marketing%20Update) This section outlines the Company's sales and marketing strategies, focusing on near-term and long-term growth drivers, and updates on distribution agreements - Near-term growth drivers include resuming in-person sales, establishing new therapy divisions (Critical Care, Cardiovascular, Liver/Kidney/other), and securing new exclusive private hospital chain partnerships in Germany[143](index=143&type=chunk)[144](index=144&type=chunk) - Longer-term growth drivers focus on expanding existing and new applications (shock, liver disease, lung injury), developing a stand-alone blood pump strategy, expanding direct sales territories (UK, Ireland, France), and investing in clinical studies[147](index=147&type=chunk) - Biocon Biologics divested its Dermatology and Nephrology businesses in India, leading to a temporary distribution agreement with Eris Lifesciences for CytoSorb products in India until December 31, 2025, with negotiations for a new agreement underway[146](index=146&type=chunk) [COVID-19 Business Update](index=45&type=section&id=COVID-19%20Business%20Update) This section details CytoSorb's application in COVID-19 patients under EUA and notes the easing of pandemic-related business impacts - CytoSorb has been used in over **7,650** COVID-19 patients globally, with U.S. Emergency Use Authorization (EUA) granted for critically ill COVID-19 patients with respiratory failure[150](index=150&type=chunk)[151](index=151&type=chunk) - The negative impacts of the COVID-19 pandemic, such as staffing shortages and reduced surgical procedures, are easing, leading to improved hospital access and patient enrollment in clinical trials[183](index=183&type=chunk)[184](index=184&type=chunk) [Government Research Grants](index=45&type=section&id=Government%20Research%20Grants) This section reports on government research grants, specifically a Phase I SBIR award from the U.S. Department of the Air Force for combat injury treatment - The Company received a Phase I SBIR award from the U.S. Department of the Air Force for **$74,918** to explore new ways to treat combat injuries, with funding fully earned as of September 30, 2023[153](index=153&type=chunk) [Research and Development Update](index=45&type=section&id=Research%20and%20Development%20Update) This section updates on research and development activities, noting a return to pre-pandemic work levels and a strategic focus on high-potential product candidates - Research and development work levels have returned to pre-pandemic levels, with **$7.6 million** remaining to be earned on open grant contracts[154](index=154&type=chunk) - The Company is consolidating R&D teams to focus on HemoDefend-BGA and DrugSorb-ATR products, identified as having the highest commercial success potential, while concluding grant obligations for HemoDefend-RBC and K+ontrol[156](index=156&type=chunk) [Impact of Inflation and Other Issues](index=47&type=section&id=Impact%20of%20Inflation%20and%20Other%20Issues) This section discusses the impact of inflation on the Company's operations, including increased labor, raw material, and energy costs - Inflation has led to increased labor costs, raw material prices (especially oil-based chemicals), and energy costs, with transportation cost increases mitigated by bulk shipping[157](index=157&type=chunk) [Comparison for the three months ended September 30, 2023 and 2022](index=47&type=section&id=Comparison%20for%20the%20three%20months%20ended%20September%2030,%202023%20and%202022) This section compares the Company's financial performance for the three months ended September 30, 2023, and 2022, focusing on revenue, gross margins, and key expenses Revenue Comparison (Three months ended Sep 30) | Revenue Category | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :--------------- | :---------- | :---------- | :---------- | :--------- | | Product sales | 7,754,000 | 6,463,000 | 1,291,000 | 20% | | Grant income | 1,057,000 | 1,649,000 | (592,000) | -36% | | Total revenues | 8,811,000 | 8,111,000 | 700,000 | 9% | - Product gross margins increased from approximately **55%** in Q3 2022 to **72%** in Q3 2023, primarily due to the absence of inefficiencies associated with the relocation of production activities[161](index=161&type=chunk) Expense Comparison (Three months ended Sep 30) | Expense Category | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :-------------------------------- | :---------- | :---------- | :---------- | :---------- | | Cost of revenue | 3,204,000 | 4,494,000 | (1,290,000) | -28.7% | | Research and development | 3,749,000 | 3,290,000 | 459,000 | 14.0% | | Legal, financial and other consulting | 1,103,000 | 610,000 | 494,000 | 81.0% | | Selling, general and administrative | 8,104,000 | 8,735,000 | (631,000) | -7.2% | | Loss on foreign currency transactions | (1,810,000) | (3,230,000) | 1,420,000 | -44.0% | [Comparison for the nine months ended September 30, 2023 and 2022](index=49&type=section&id=Comparison%20for%20the%20nine%20months%20ended%20September%2030,%202023%20and%202022) This section compares the Company's financial performance for the nine months ended September 30, 2023, and 2022, focusing on revenue, gross margins, and key expenses Revenue Comparison (Nine months ended Sep 30) | Revenue Category | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :--------------- | :---------- | :---------- | :---------- | :--------- | | Product sales | 23,736,000 | 21,718,000 | 2,019,000 | 9% | | Grant income | 3,945,000 | 3,580,000 | 364,000 | 10% | | Total revenues | 27,681,000 | 25,298,000 | 2,383,000 | 9% | - Product gross margins increased from approximately **68%** in the nine months ended September 30, 2022, to **71%** in the same period of 2023, driven by production efficiencies at the new manufacturing facility[172](index=172&type=chunk) Expense Comparison (Nine months ended Sep 30) | Expense Category | 2023 ($) | 2022 ($) | Change ($) | Change (%) | | :-------------------------------- | :---------- | :---------- | :---------- | :---------- | | Cost of revenue | 10,600,000 | 10,322,000 | 278,000 | 2.7% | | Research and development | 11,632,000 | 11,717,000 | (85,000) | -0.7% | | Legal, financial and other consulting | 2,958,000 | 2,089,000 | 869,000 | 41.6% | | Selling, general and administrative | 24,358,000 | 26,335,000 | (1,977,000) | -7.5% | | Loss on foreign currency transactions | (734,000) | (6,967,000) | 6,233,000 | -89.5% | [History of Operating Losses](index=51&type=section&id=History%20of%20Operating%20Losses) This section details the Company's history of operating losses, including its accumulated deficit and net losses for recent periods - As of September 30, 2023, the Company had an accumulated deficit of approximately **$276,670,000**, including net losses of **$22,672,000** and **$32,046,000** for the nine-month periods ended September 30, 2023 and 2022, respectively[177](index=177&type=chunk) [Liquidity and Capital Resources](index=51&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the Company's liquidity and capital resources, highlighting its cash position, the need for additional funding, and available ATM facility - As of September 30, 2023, the Company had approximately **$10.0 million** in cash (including **$8.4 million** unrestricted and **$1.7 million** restricted), which is expected to fund operations only through Q1 2024[181](index=181&type=chunk) - The Company needs to raise additional capital and is exploring various sources, including debt financing, royalty financing, strategic or direct investments, and equity financing[181](index=181&type=chunk) - Approximately **$22.8 million** remains available under the Company's **$25 million** ATM facility[180](index=180&type=chunk) [Contractual Obligations](index=53&type=section&id=Contractual%20Obligations) This section outlines the Company's contractual obligations, primarily focusing on long-term lease agreements for its operating facilities - The Company has lease agreements for operating facilities in New Jersey and Germany, with the main Princeton facility lease extending for **15.5 years** from September 2021[185](index=185&type=chunk) [Off-balance Sheet Arrangements](index=54&type=section&id=Off-balance%20Sheet%20Arrangements) This section confirms that the Company has no off-balance sheet arrangements to report - The Company has no off-balance sheet arrangements[188](index=188&type=chunk) [Going Concern](index=54&type=section&id=Going%20Concern) This section addresses the Company's going concern status, noting insufficient cash to fund operations beyond twelve months - The Company's cash position of approximately **$10.0 million** as of September 30, 2023, is insufficient to fund operations beyond twelve months, raising substantial doubt about its ability to continue as a going concern[189](index=189&type=chunk) [Critical Accounting Policies and Estimates](index=54&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section refers to the Company's Annual Report on Form 10-K for a detailed discussion of critical accounting policies and estimates - A discussion of critical accounting policies and estimates is contained in the Company's Annual Report on Form 10-K[190](index=190&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=54&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms that quantitative and qualitative disclosures about market risk are not applicable for this report - Quantitative and qualitative disclosures about market risk are not applicable[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=54&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting - Management concluded that disclosure controls and procedures were functioning effectively as of September 30, 2023[193](index=193&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended September 30, 2023[194](index=194&type=chunk) [PART II. OTHER INFORMATION](index=56&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=56&type=section&id=Item%201.%20Legal%20Proceedings) The Company settled a litigation matter for **$280,000**, recorded as a liability and expense, with no other current legal proceedings - The Company settled a litigation matter for **$280,000**, included in accrued expenses and other current liabilities[196](index=196&type=chunk) - The Company is not currently a party to any other legal proceedings[197](index=197&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, highlighting the Company's history of losses, going concern doubt, economic risks in Germany, geopolitical instability, and the continuous need for additional capital - The Company has a history of substantial operating losses, with an accumulated deficit of approximately **$276,670,000** as of September 30, 2023, and its auditor's report expresses substantial doubt about its ability to continue as a going concern[199](index=199&type=chunk) - Adverse economic conditions in Germany, which accounts for approximately **40%** of net product sales, or broader economic/political instability in the EU or globally, could negatively impact the Company's business[200](index=200&type=chunk)[202](index=202&type=chunk) - Geopolitical tensions and conflicts, such as the Russia-Ukraine conflict and the Israel-Gaza conflict, could disrupt commerce and negatively affect the Company's global operations and financial condition[203](index=203&type=chunk) - The Company will require additional capital to fund future operations, commercialization, clinical studies, and working capital, with no assurance of obtaining such financing on acceptable terms[204](index=204&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=60&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section confirms no unregistered sales of equity securities or use of proceeds were reported - No unregistered sales of equity securities or use of proceeds to report[209](index=209&type=chunk) [Item 3. Defaults Upon Senior Securities](index=60&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities to report - No defaults upon senior securities to report[210](index=210&type=chunk) [Item 4. Mine Safety Disclosures](index=60&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that mine safety disclosures are not applicable for this report - Mine safety disclosures are not applicable[211](index=211&type=chunk) [Item 5. Other Information](index=60&type=section&id=Item%205.%20Other%20Information) This section discloses a 10b5-1 Trading Plan adoption and the termination of a public offering process due to market conditions, with the Company pursuing alternative capital sources - Vincent Capponi, President and COO, adopted a 10b5-1 Trading Plan for the sale of up to **62,700** shares of common stock between January 2, 2024, and March 28, 2024[212](index=212&type=chunk) - The Company terminated a confidential marketing process for an underwritten public offering due to market conditions not being conducive for terms in the best interest of stockholders[213](index=213&type=chunk) - The Company continues to pursue alternative capital sources, including debt financing, royalty financing, strategic or direct investments, and equity financing[214](index=214&type=chunk) [Item 6. Exhibits](index=61&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including employment agreements, certifications, and XBRL data - Exhibit 10.1 includes the Employment Agreement for Ms. Kathleen Bloch, dated September 18, 2023[215](index=215&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer are furnished under Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[215](index=215&type=chunk) - XBRL formatted financial statements and cover page interactive data file are included as Exhibits 101 and 104[215](index=215&type=chunk) [Signatures](index=62&type=section&id=Signatures) This section contains the signatures of the Company's Chief Executive Officer and Chief Financial Officer, certifying the report - The report is signed by Phillip P. Chan, Chief Executive Officer, and Kathleen P. Bloch, Chief Financial Officer, on November 9, 2023[221](index=221&type=chunk)

Cytosorbents Corporation. (NASDAQ:CTSO) Q2 2023 Earnings Conference Call August 1, 2023 4:30 PM ET Company Participants Taylor Devlin - Revenue Accountant Phillip Chan - Chief Executive Officer Vincent Capponi - President and Chief Operating Officer Kathleen Bloch - Interim Chief Financial Officer Efthymios Deliargyris - Chief Medical Officer Christopher Cramer - Senior Vice President of Business Development Irina Kulinets - Senior Vice President of Regulatory Conference Call Participants Joshua Jennings - ...

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, 2023 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 ...

Cytosorbents Corporation (NASDAQ:CTSO) Q1 2023 Results Earnings Conference Call May 2, 2023 4:30 AM ET Company Participants Taylor Devlin - Revenue Accountant Phillip Chan - Chief Executive Officer Kathleen Bloch - Interim Chief Financial Officer Efthymios Deliargyris - Chief Medical Officer Christian Steiner - Executive Vice President of Sales and Marketing Conference Call Participants Thomas Kerr - Zacks Investment Research Sean Lee - H.C. Wainwright & Co. Operator Good afternoon and welcome to the Cytoso ...