What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-06 compared with 2026-05-13 · 124 added, 53 removed, 135 unchanged (57% of the section changed)

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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:

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.

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DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.

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.

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.

Upon approval, the Company expects to rapidly commercialize DrugSorb-ATR in the United States and Canada to address this large unmet medical need, with an initial estimated total addressable market of $300 million today to over $1 billion over time as we pursue additional indications for DrugSorb-ATR to remove additional classes of blood thinners and expansion of the antithrombotic removal application beyond cardiac surgery and across other surgical specialties.

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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).

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).

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.

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.

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.

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.

DrugSorb-ATR® for DOACs:

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At the same time, we continue to observe increasing real-world adoption, clinical use, and published evidence supporting the use of our technology for DOAC removal in cardiac surgery, reinforcing the significant unmet medical need globally.

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.

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.

Having this second shot on goal is aligned with our other FDA Breakthrough Device Designation for DrugSorb-ATR, to remove DOACs during cardiac surgery.

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Summary of Operational and Recent Business Highlights

● Total revenue was $8.9 million for the three months ended March 31, 2026, an increase of $0.1 million, or 1.6%, compared to the prior year.

● Gross profit was $6.1 million for the three months ended March 31, 2026, a decrease of $0.1 million, or 1.2%, compared to the prior year.

Gross margin was 69% for the three months ended March 31, 2026, compared to 71% in the prior year.

● Loss from operations improved by 21.7% to approximately $3.0 million, from $3.9 million for the three months ended March 31, 2026, and 2025, respectively.

● Total revenue was $18.5 million for the six months ended June 30, 2026, an increase of $0.2 million, or 0.8%, compared to the prior year.

For the three months ended June 30, 2026, total revenue was $9.6 million, an increase of 0.2%.

● Gross profit was $13.2 million for the six months ended June 30, 2026, an increase of $0.2 million, or 1.2%, compared to the prior year.

Gross margin was 71.2% for the six months ended June 30, 2026, compared to 71.0% in the prior year.

Gross profit for the three months ended June 30, 2026, was $7.0 million, an increase of $0.2 million or 3.4% compared to the prior year.

Gross margin was 73.2% for the three months ended June 30, 2026, compared to 70.9% in the prior year.

● Loss from operations improved by 24% to approximately $5.7 million, from $7.5 million for the six months ended June 30, 2026, and 2025, respectively.

For the three-month ended June 30, 2026 and 2025, loss from operations improved by 27% to approximately $2.6 million.

● Operating cash burn decreased to $0.4 million for the second quarter and $1.8 million for the six months ended June 30, 2026, compared to $1.4 million and $4.9 million for the three and six months ended June 30, 2025, respectively.

The decrease is primarily due to improved operating margins and the impact of our strategic workforce and cost reduction plan.

The Company continues to expect to achieve operating cash flow break-even in the second half of 2026.

and Canadian pivotal STAR-T randomized, controlled trial results have now been published in the Journal of Thoracic and Cardiovascular Surgery (2026) - the leading peer-reviewed cardiothoracic surgery journal in the U.S.

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Results of Operations:

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

Three Months Ended March 31,

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

Three Months Ended June 30,

(in thousands)

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Selling, general and administrative

Restructuring

Total operating expenses

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Total other income (expense), net

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.

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.

Net income (loss)

For the three months ended June 30, 2026, we generated total revenue of approximately $9.6 million, which is in line with revenues for the three months ended June 30, 2025, of $9.6.

Revenue performance was led by increases in our distributor and strategic partner territories and direct sales outside Germany, but offset by a decline in sales in Germany attributed to a smaller bot more focused sales force.

Changes in foreign currency rates positively impact revenue by approximately 4% compared to the prior year.

Gross profit was approximately $7.0 million for the three months ended June 30, 2026, an increase of approximately $0.2 million, or 3.4%, as compared to gross profit of $6.8 million for the three months ended June 30, 2025.

Gross margins were 73.2% and 70.9% for the three months ended June 30, 2026 and 2025, respectively.

The improvement in gross margins reflects the impact of efforts to rebalance production, lower operating costs, and improve efficiencies.

Research and Development Expenses

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.

Research and development costs were approximately $1.5 million and $1.3 million for the three months ended June 30, 2026 and 2025, respectively, an increase of approximately $0.2 million, or 15.1%.

This increase was primarily driven by a charge in the quarter for a certain critical care clinical study.

Selling, General and Administrative Expenses

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

to the full vesting of certain stock options in earlier periods.

The decrease in salaries and compensation was primarily related to our strategic workforce and cost reduction program initiated in the fourth quarter of 2025 which reduced our workforce by approximately 10%.

Our selling, general and administrative expenses were approximately $8.0 million and $9.2 million for the three months ended June 30, 2026 and 2025, respectively, a decrease of approximately $1.2 million, or 13%.

The decrease is primarily due to lower legal, financial and consulting expenses compared to the prior year of approximately of $0.8 million as well as net lower compensation costs in the current year.

Gain (Loss) on Foreign Currency Transactions

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.

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.

Restructuring

During the fourth quarter of 2025 and through the second quarter of fiscal 2026, the Company initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability.

Our restructuring expenses were approximately $0.3 million for the three months ended June 30, 2026.

These costs included cash-based severance and related workforce reduction charges of $0.3 million.

There were no charges for the three months ended June 30, 2025.

Loss From Operations

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.

Six Months Ended June 30,

(in thousands)

Cost of goods sold

Operating expenses:

Research and development

Selling, general and administrative

Restructuring

Total operating expenses

Loss from operations

Other income (expense):

Interest expense, net

Gain (loss) on foreign currency transactions

Total other income (expense), net

Net income (loss)

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.

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.

Research and Development Expenses

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.

Restructuring

During the fourth quarter of 2025 and into the second quarter of fiscal 2026, the Company initiated a strategic workforce and cost reduction plan (the “Strategic Workforce and Cost Reduction Plan”) to reduce costs, optimize operations, and accelerate a path to cash-flow profitability.

Our restructuring expenses were approximately $0.3 million for the six months ended June 30, 2026.

These costs included cash-based severance and related workforce reduction charges of $0.3 million.

There were no charges for the six months ended June 30, 2025.

Selling, General and Administrative Expenses

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.

Gain (Loss) on Foreign Currency Transactions

For the six months ended June 30, 2026, the loss on foreign currency transactions was approximately $2.1 million, as compared to a gain on foreign currency transactions of approximately $9.2 million for the six months ended June 30, 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.

dollar as of June 30, 2026, to $1.1414 per Euro from $1.1750 per Euro as of 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.

dollar as of June 30, 2025, to $1.1789 per Euro from $1.0349 per Euro as of December 31, 2024.

Loss From Operations

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.

Our loss from operations decreased by 24.3% to approximately $5.7 million, from $7.5 million for the six months ended June 30, 2026, and 2025, respectively.

This improvement was primarily the result of an 8.1% reduction in operating expenses compared to the prior year, resulting from our efforts to lower costs and improve operating margins and efficiencies including the Company’s Strategic Workforce and Cost Reduction Plan, which are all consistent with our goal to achieve cash flow breakeven in the second half of 2026.

Liquidity and Capital Resources

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.

As of June 30, 2026, we had current assets of approximately $15.7 million and current liabilities of approximately $24.0 million.

Net change in cash, cash equivalents and restricted cash

The following summary presents the sources and uses of cash in our operating, investing, and financing activities, and the related effect of exchange rates on cash:

Three Months Ended June 30,

Six Months Ended June 30,

(amounts, in thousands)

Net cash used in operating activities

Net cash provided by (used in) investing activities

Net cash provided by financing activities

Effect of exchange rates on cash

Net change in cash, cash equivalents, and restricted cash

The reduction in net cash used in operating activities during the three and six months ended June 30, 2026, compared to the same periods in the prior year, of $0.9 million and $3.2 million, respectively, was primarily attributable to the initial benefits of the Company’s Strategic Workforce and Cost Reduction Plans, which are further discussed in this Management’s Discussion and Analysis of Financial Condition and Results of Operations under “Resource Allocation and Path to Cash-Flow Profitability”.

Nasdaq Listing Compliance

On October 2, 2025, the Company received notice from the Staff Nasdaq that it was not in compliance with the Minimum Bid Price Requirement.

The Company did not regain compliance during the initial 180-day period ended March 31, 2026, and on April 1, 2026 the Staff granted a second 180-day compliance period, until September 28, 2026, to regain compliance with the Minimum Bid Price Requirement in accordance with Nasdaq Listing Rule 5810(c)(3)(A).

To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive trading days prior to September 28, 2026.

On June 29, 2026, the Company received a letter from the Staff of Nasdaq that the Company was not in compliance with Nasdaq Listing Rule 5550(b)(2) because the Company’s minimum Market Value of Listed Securities was below the minimum of $35 million required for continued listing on the Nasdaq Capital Market (the “MVLS Requirement”).

In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided the Company with 180 calendar days, or until December 28, 2026, to regain compliance with the MVLS Requirement.

Management’s plans with respect to the Company’s continued listing requirements include actively monitoring the bid price and market value of the Company’s common stock, pursuing potential capital-raising transactions, and, if necessary, effecting a reverse stock split to regain compliance with the minimum bid price requirement.

The Company may also seek to satisfy an alternative continued listing standard, such as by increasing its stockholders’ equity to at least $2.5 million.

There can be no assurance that the Company will regain compliance with the applicable Nasdaq continued listing requirements, that any such actions will result in a sustained increase in the Company’s stock price or market value of listed securities, or that the Company’s common stock will continue to be listed on Nasdaq.

As of the date these financial statements are issued, the Company has not regained compliance with either requirement.

The Company’s common stock continues to trade on The Nasdaq Capital Market under the symbol “CTSO.” If the Company does not regain compliance by the applicable compliance dates, Nasdaq will notify the Company that its securities are subject to delisting, and the Company may appeal such determination to a Nasdaq Hearings Panel.

Effective Shelf Registration

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;

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.

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.

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.

Loan and Security Agreement

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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.

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%).

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Resource Allocation and Path to Cash-Flow Profitability

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.

As of March 31, 2026, we had approximately $6.3 million in cash, including approximately $4.8 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.

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.

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.

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.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis