Cytosorbents Corp

Previous wording

In the United States and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two United States Food and Drug Administration (“FDA”) Breakthrough Device

Current wording

In the United States and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two United States Food and Drug Administration (“FDA”) Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures.

Previous wording

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued United States and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. While not our primary means of communication, investors can learn more about us by visiting our social media channels. We encourage investors, the media, and others interested in us to review the information posted on our Facebook site and our X account, where investors, the media, and other interested parties can subscribe. The information contained in our social media accounts is not incorporated into this Quarterly Report on Form 10-Q or other documents we file with or furnish to, the SEC.

Current wording

The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued United States and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, PuriFi®, HotSwap™ and others. While not our primary means of communication, investors can learn more about us by visiting our social media channels. We encourage investors, the media, and others interested in us to review the information posted on our Facebook site and our X account, where investors, the media, and other interested parties can subscribe. The information contained in our social media accounts is incorporated into this Quarterly Report on Form 10-Q or other documents we file with or furnish to, the SEC.

Previous wording

In August 2025, we received the FDA’s decision on our appeal of the original DrugSorb-ATR application. Importantly, the Agency identified no concerns regarding device safety but upheld the prior denial of the application and requested additional information to support the proposed indication for reducing the severity of perioperative bleeding in patients undergoing CABG surgery while on Brilinta® (ticagrelor, AstraZeneca).

Current wording

In August 2025, we received the FDA’s decision on our appeal of the original DrugSorb-ATR application. Importantly, the FDA identified no concerns regarding device safety but upheld the prior denial of the application and requested additional analysis of real-world evidence to support the proposed indication for reducing the severity of perioperative bleeding in patients undergoing CABG surgery while on Brilinta® (ticagrelor, AstraZeneca).

Previous wording

Following the appeal decision and based upon feedback from FDA, we announced our intention to submit a new De Novo application incorporating additional supporting information, primarily based on real-world evidence and clinical outcomes generated through routine clinical use of the device. As part of this process, we held a formal pre-submission meeting with the FDA in late January 2026 and have continued to engage with the Agency to clarify the requirements for the new De Novo submission, including whether certain information could potentially be submitted as a post-marketing requirement rather than as part of the initial application. Based on these interactions, the FDA has requested additional mechanistic data to be included alongside the real-world evidence within the new De Novo submission.

Current wording

Following the appeal decision and based upon feedback from FDA, we announced our intention to submit a new De Novo application incorporating additional supporting information, primarily based on real-world evidence and clinical outcomes generated through routine clinical use of the device. As part of this process, we held a formal pre-submission meeting with the FDA in late January 2026 and have continued to engage with the FDA to clarify the requirements for the new De Novo submission, including whether certain information could potentially be submitted as a post-marketing requirement rather than as part of the initial application. Based on these interactions, the FDA has requested additional mechanistic data to be included alongside the real-world evidence within the new De Novo submission.

Previous wording

We are currently evaluating options to generate the additional mechanistic data on an expedited basis and expect to schedule an additional pre-submission meeting with the FDA, if needed, to discuss and align the proposed approach. Once alignment is achieved, we anticipate completing the required work and submitting a new De Novo application in late 2026 or early 2027. Following submission, a regulatory decision would generally be expected within the FDA’s targeted 150-day MDUFA review timeline, although the actual review period may be shorter or longer depending on the nature and extent of interactive review questions from the Agency.

Current wording

We have scheduled a pre-submission meeting with the FDA in August 2026 to discuss the options to generate this additional mechanistic data. Following this meeting, we expect to finalize the testingprotocol, which may require an additional meeting with the FDA. Once finalized, we anticipate completing the required testing and submitting a new De Novo application in early 2027. Following submission, a regulatory decision would generally be expected within the FDA’s targeted 150-day MDUFA review timeline, although the actual review period may be shorter or longer depending on the nature and extent of interactive review questions from the FDA.

Previous wording

Within the next 30 days, we plan to submit a separate pre-submission request to the Agency to review the data currently available for the DOAC indication that include drug removal data from benchtop testing and data from real-world use and determine what, if any, additional information may be required to support a parallel De Novo submission for DOAC removal.

Current wording

We have scheduled a separate pre-submission meeting with the FDA to review the data currently available for the DOAC indication that include drug removal data from benchtop testing and data from real-world use and determine what, if any, additional information may be required to support a parallel De Novo submission for DOAC removal.

Previous wording

Comparison for the three months ended March 31, 2026 and 2025:

Current wording

Comparison for the six months ended June 30, 2026 and 2025:

Previous wording

For the three months ended March 31, 2026, the loss on foreign currency transactions was approximately $1.2 million, as compared to a gain on foreign currency transactions of approximately $3.0 million for the three months ended March 31, 2025. The loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of March 31, 2026 compared to December 31, 2025. The current year loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of March 31, 2026, to $1.15 per Euro from $1.17 per Euro at December 31, 2025. The prior year gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of March 31, 2025, to $1.08 per Euro from $1.03 per Euro at December 31, 2024.

Current wording

For the six months ended June 30, 2026, the loss on foreign currency transactions was approximately $0.9 million, as compared to a gain on foreign currency transactions of approximately $6.2 million for the three months ended June 30, 2025. The current quarter loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2026, to $1.1414 per Euro from $1.1498 per Euro as of March 31, 2026. The prior year gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar as of June 30, 2025, to $1.1789 per Euro from $1.0349 per Euro as of December 31, 2024.

Previous wording

Our loss from operations decreased by 21.7% to approximately $3.0 million, from $3.9 million for the three months ended March 31, 2026, and 2025, respectively. This improvement was primarily the result of a 9.1% reduction in operating expenses year over year.

Current wording

Our loss from operations improved by 27% to approximately $2.6 million, from $3.6 million for the three months ended June 30, 2026, and 2025, respectively. This improvement was primarily the result of improved gross margins and a 7.1% reduction in total operating expenses quarter over quarter resulting from.

Previous wording

For the three months ended March 31, 2026, we generated total revenue of approximately $8.9 million, an increase of approximately $0.2 million, or 1.6%, and down 7.4% on a constant currency basis, as compared to revenues of approximately $8.7 million for the three months ended March 31, 2025. Revenue growth was led by double digit growth in direct sales outside of Germany, partially offset by lower revenue in our direct German market, where we continue to see signs of improved sale processes, account targeting and customer engagement with a smaller and more focused team. We remain confident these improvements will lead to stronger execution and improved performance. Distributor sales were flat year-over-year, as progress across several territories was offset by delayed distributor orders of approximately $0.5 million in parts of the Middle East and neighboring regions due to geopolitical and economic instability related to the U.S.-Iran war. This unexpected disruption has slowed the anticipated growth of our recently established subsidiary in Dubai, UAE, although we expect conditions to improve as the conflict stabilizes.

Current wording

For the six months ended June 30, 2026, we generated total revenue of approximately $18.5 million, an increase of approximately $0.2 million, or 1%, compared to revenues of approximately $18.3 million for the six months ended June 30, 2025. Revenue growth was led by strength in our distributor and strategic partner territories and direct sales outside Germany, offset by a reduction in sales in Germany. We continue to see signs of improved sale processes, account targeting and customer engagement with a smaller and more focused team in Germany and remain confident these improvements will lead to stronger execution and improved performance. Meanwhile, we expect to add bak 3-4 additional sales representatives in Germany in the second half of 2026. Changes in foreign currency rates positively impact revenue by approximately 6% compared to the prior year.

Previous wording

Gross profit was approximately $6.1 million for the three months ended March 31, 2026, a decrease of approximately $0.1 million, or 1.2%, as compared to gross profit of $6.2 million for the three months ended March 31, 2025. Gross margins were 69.2% and 71.1% for the three months ended March 31, 2026 and 2025, respectively.

Current wording

Gross profit was approximately $13.2 million for the three months ended June 30, 2026, an increase of approximately $0.2 million, or 1.2%, as compared to gross profit of $13.0 million for the six months ended June 30, 2025. Gross margins were 71.2% and 71.0% for the six months ended June 30, 2026 and 2025, respectively.

Previous wording

Our research and development costs were approximately $1.0 million and $1.7 million for the three months ended March 31, 2026 and 2025, respectively, a decrease of approximately $0.7 million, or 38.4%. This decrease was driven by a decrease in our clinical trial costs due primarily to the completion of the STAR-T clinical trial, lower grant funded projects, as well as other clinical and product development program reductions.

Current wording

Research and development costs were approximately $2.5 million and $2.9 million for the six months ended June 30, 2026 and 2025, respectively, a decrease of approximately $0.4 million, or 15.3%. This decrease was driven by a decrease in our clinical trial costs and lower grant funded projects, as well as other clinical and product development program reductions, including lower compensation costs.

Previous wording

Our selling, general and administrative expenses were approximately $8.1 million and $8.4 million for the three months ended March 31, 2026 and 2025, respectively, a decrease of approximately $0.3 million, or 3.5%. The decrease is primarily due to decreases in stock-based compensation expense of $0.2 million and a decrease in salaries and compensation expense of $0.2 million, partially offset by a reduction in benefits from government grants of $0.1 million. The decrease in stock-based compensation expense was primarily related

Current wording

Our selling, general and administrative expenses were approximately $16.1 million and $17.6 million for the six months ended June 30, 2026 and 2025, respectively, a decrease of approximately $1.5 million, or 8.5%. The decrease is primarily due to decreases in legal, financial and consulting expenses of $0.5 million, total compensation expense of $0.8 million, and a decrease in selling expenses of $0.2 million.

Previous wording

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of March 31, 2026, we had current assets of approximately $17.8 million and current liabilities of approximately $16.3 million.

Current wording

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of June 30, 2026, we had current assets of approximately $15.7 million and current liabilities of approximately $24.0 million.

Previous wording

We have an effective shelf registration statement dated September 30, 2024 (the “Shelf”) with the SEC which enables us to raise up to $150 million in one or more offerings, through the issuance and sale of any combination of equity securities, debt securities, warrants and units. Approximately $149.7 million of this amount was available as of March 31, 2026; however the use of the Shelf is subject to a limitation of one-third of our public float in any rolling twelve-month period, when our public float is below $75 million, which is referred to as the “baby shelf” rules. We have also allocated $20 million of our total shelf amount to our ATM facility. At March 31, 2026, approximately $19.4 million was available for use under the ATM facility, subject to certain limitations. During the three months ended March 31, 2026, we did not raise any proceeds under the ATM facility.

Current wording

We have an effective shelf registration statement dated September 30, 2024 (the “Shelf”) with the SEC which enables us to raise up to $150 million in one or more offerings, through the issuance and sale of any combination of equity securities, debt securities, warrants and units. Approximately $149.7 million of this amount was available as of June 30, 2026; however, the use of the Shelf is subject to a limitation of one-third of our public float in any rolling twelve-month period, when our public float is below $75 million, which is referred to as the “baby shelf” rules. We have also allocated $20 million of our total shelf amount to our ATM facility. As of June 30, 2026, approximately $19.4 million was available for use under the ATM facility, subject to certain limitations. During the six months ended June 30, 2026, we did not raise any proceeds under the ATM facility.

Previous wording

On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million (the “Avenue Capital Commitment”), to be disbursed in two tranches. The first tranche of $15.0 million (“Tranche 1”), consisted of $10.0 million which was available to the Company on the Closing Date and $5.0 million constituted restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company received a minimum of $3.0 million in net proceeds from the sale of its equity securities after the Closing Date. The restriction was released on a dollar-for-dollar basis for equity raised between $3.0 million and $5.0 million. The second tranche (“Tranche 2”) consisted of $5.0 million, which would have been disbursed at the Company’s request between July 1, 2025 and December 31, 2025, if the Company receives FDA marketing approval of its DrugSorb-ATR application, which it did not. The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and were additionally be used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent (5.00%) or (B) thirteen and one-half percent (13.50%). The loan required interest-only payments for the first 24 months through July 1, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity, on July 1, 2027; provided, however that if the Company had drawn the full amount of Tranche 2 by December 31, 2025, and achieved for the trailing six month period ended June 30, 2026, at least $25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period would have been extended by six months to January 1, 2027, followed by equal monthly installments of principal plus accrued and unpaid interest through January 1, 2028.

Current wording

On June 28, 2024 (the “Closing Date”), the Company entered into a Loan and Security Agreement with the Avenue Capital Group (“Loan”). Avenue Capital Group agreed to loan the Company up to an aggregate of $20 million (the “Avenue Capital Commitment”), to be disbursed in two tranches. The first tranche of $15.0 million (“Tranche 1”), consisted of $10.0 million which was available to the Company on the Closing Date and $5.0 million constituted restricted cash, which was released from its restriction on January 10, 2025, as the following conditions were achieved: (i) the FDA has accepted Company’s application for review with respect to DrugSorb-ATR De Novo 510(k) and (ii) the Company received a minimum of $3.0 million in net proceeds from the sale of its equity securities after the Closing Date. The restriction was released on a dollar-for-dollar basis for equity raised between $3.0 million and $5.0 million. The second tranche (“Tranche 2”) consisted of $5.0 million, which would have been disbursed at the Company’s request between July 1, 2025 and December 31, 2025, if the Company received FDA marketing approval of its DrugSorb-ATR application, which it did not. The proceeds from the Avenue Capital Commitment were used to pay off the existing outstanding debt with Bridge Bank and were additionally used for working capital purposes and to fund general business requirements. Amounts borrowed under the Avenue Capital Commitment bear interest at a variable rate per annum equal to the greater of (A) the Prime Rate plus five percent (5.00%) or (B) thirteen and one-half percent (13.50%). The loan required interest-only payments for the first 24 months through July 1, 2026, followed by equal monthly installments of principal plus accrued and unpaid interest until maturity, on July 1, 2027; provided, however that if the Company had drawn the full amount of Tranche 2 by December 31, 2025, and achieved for the trailing six month period ended June 30, 2026, at least $25 million of revenue, (the Interest only Milestone as defined in the Loan), the Interest only Period would have been extended by six months to January 1, 2027, followed by equal monthly installments of principal plus accrued and unpaid interest through January 1, 2028.

Previous wording

We proactively manage our resources with a focus on driving commercial success, investing in key areas such as our regulatory submissions of DrugSorb-ATR to the FDA and Health Canada and the development of clinical data. We have instituted and continue to maintain tight control over expenditures and have lowered our spending over the past year. Further, on November 13, 2025, the Company announced it initiated a Strategic Workforce and Cost Reduction Plan to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. This initiative follows a comprehensive review of the Company’s cost structure and operating model. As part of the Strategic Workforce and Cost Reduction Plan, the Company reduced its workforce by approximately 10%, reduced and realigned operating and production expenses in the fourth quarter of 2025, continued to make additional reductions in the first quarter of 2026, and remains committed to bringing the Company to operating cash flow break-even in the second half of 2026. The Company recorded a charge of $0.5 million in 2025 that includes severance and other cash and non-cash charges related to the restructuring.

Current wording

We have strategically managed our resources with a focus on driving commercial success, investing in key areas such as our regulatory submissions of DrugSorb-ATR and the development of clinical data, while also driving improved efficiencies and operating margins. Further, during the fourth quarter of 2025 and into the second quarter of fiscal 2026, the Company initiated a Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability. These initiatives followed a comprehensive review of the Company’s cost structure and operating model. As a result of the Strategic Workforce and Cost Reduction Plan and attrition, the Company has reduced its workforce by approximately 23%, and reduced and realigned operating and production expenses. As a result, the Company has decreased its operating cash burn to approximately $0.4 million for the three months ended June 30, 2026 and remains committed to bringing the Company to operating cash flow break-even in the second half of 2026.

Previous wording

considered with our historical and expected future cash used in operations, notwithstanding our Strategic Workforce and Cost Reduction Plan and the impact of the Amended Loan and Security Agreement, raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued.

Current wording

As of June 30, 2026, we had approximately $5.9 million in cash, including approximately $4.4 million in unrestricted cash and cash equivalents and $1.5 million of non-current restricted cash which may not be sufficient to fund the Company’s operations beyond the next twelve months from the issuance of these condensed consolidated financial statements. These cash and restricted cash balances considered with our historical and expected future cash used in operations, notwithstanding our Strategic Workforce and Cost Reduction Plan and the impact of the Amended Loan and Security Agreement, raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying condensed consolidated financial statements are issued.

Previous wording

Our expected future capital requirements may depend on many factors, including expanding our customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the United States. Additional sources of liquidity available to us include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources. The sale of additional equity may result in dilution to our shareholders. There is no assurance that we will be able to secure funding on terms acceptable to us, or at all. Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential increased need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available to us as needed, we may be required to take certain actions, such as slowing sales and marketing expansion, delaying further regulatory approvals, or reducing headcount. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.

Current wording

Our expected future capital requirements may depend on many factors, including the ability to continue to reduce cash burn and achieve operating cash flow breakeven in the second half of 2026, expanding our customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the United States. Additional sources of liquidity available to us include the 2024 Shelf, other public or private equity offerings, debt financing or from other sources. The sale of additional equity may result in dilution to our shareholders. There is no assurance that we will be able to secure funding on terms acceptable to us, or at all. Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential increased need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available to us as needed, we may be required to take certain actions, such as slowing sales and marketing expansion, delaying further regulatory approvals, or reducing headcount. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.