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EBR Systems, Inc.

For the period ended Sep 30, 2026. Filed Nov 9, 2026.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 9, 2026

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What changed in Management’s Discussion and Analysis?

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Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-11.

0001214659-26-009897

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-09.

0001214659-26-013871

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 106 previous paragraphs and 107 current paragraphs.

77 unchanged; 29 reworded; 1 added; 0 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 39 previous and 39 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (1)

Current report

In August 2026, we completed Tranche 2 of the fully underwritten institutional placement, and issued 92,105,270 CDIs, representing 9,210,527 shares of common stock at a purchase price of A$0.38 per CDI (A$3.80 per share of common stock), for proceeds of $23.7 million, net of $1.4 million of related issuance costs.
Reworded paragraphs (29)

Previous wording

We have launched WiSE with the focus on driving adoption of WiSE at key, high-volume, hospitals or medical facilities within the U.S. to be followed by select, high-volume hospitals or medical facilities in markets outside the U.S. (“OUS”) that we would target after evaluating regulatory and reimbursement considerations. The growth of our business depends on our ability to successfully commercialize WiSE and gain wide acceptance of WiSE by continuing to make physicians and other hospital staff aware of the benefits of WiSE to generate increased demand and frequency of use and thus increase sales to our hospital customers. Our ability to grow our business will also depend on our ability to expand our customer base in existing or new target markets. The rate at which we grow our sales force and the speed at which newly hired salespeople become effective can impact our revenue growth or our costs incurred in anticipation of such growth. We intend to make significant investments in our sales and marketing organization by increasing the number of U.S. sales representatives and expanding our international marketing programs to help facilitate further adoption among existing hospital accounts as well as broaden awareness of our products to new hospital accounts.

Current wording

We have launched WiSE with the focus on driving adoption of WiSE at key, high-volume, hospitals or medical facilities within the U.S. to be followed by select, high-volume hospitals or medical facilities in markets outside the U.S. (“OUS”) that we would target after evaluating regulatory and reimbursement considerations. The growth of our business depends on our ability to successfully commercialize WiSE and gain wide acceptance of WiSE by continuing to make physicians and other hospital staff aware of the benefits of WiSE to generate increased demand and frequency of use and thus increase sales to our hospital customers. Our ability to grow our business will also depend on our ability to expand our customer base in existing or new target markets. The rate at which we grow our sales force and the speed at which newly hired salespeople become effective can impact our revenue growth or our costs incurred in anticipation of such growth. We intend to make significant investments in our sales and marketing organization by increasing the number of sales representatives and expanding our marketing programs, in the U.S., to help facilitate further adoption among existing hospital accounts as well as broaden awareness of our products to new hospital accounts.

Previous wording

Our WiSE CRT System received approval from the FDA for commercial distribution in April 2025, and we began commercializing WiSE during the second quarter of 2025. During the three months ended June 30, 2026, we had 46 commercial implants at 23 hospitals in the US, and recognized net sales of $2.6 million. During the six months ended June 30, 2026, we had 87 commercial implants at 29 hospitals in the US, and recognized net sales of $5.0 million. An additional 48 physicians were trained to implant the WiSE CRT System, and 32 additional purchase agreements were signed with target Limited Market Release (“LMR”) sites during the six months ended June 30, 2026. The commercial potential of and our ability to successfully commercialize WiSE is unproven and will require, among other things, effective sales, marketing, manufacturing, distribution, information systems and pricing strategies, as well as compliance with applicable laws and regulations.

Current wording

Our WiSE CRT System received approval from the FDA for commercial distribution in April 2025, and we began commercializing WiSE during the second quarter of 2025. During the three months ended September 30, 2026, we had 40 commercial implants at 24 hospitals in the US, and recognized net sales of $2.5 million. During the nine months ended September 30, 2026, we had 127 commercial implants at 41 hospitals in the US, and recognized net sales of $7.5 million. An additional 58 physicians were trained to implant the WiSE CRT System, and 43 additional purchase agreements were signed with target Limited Market Release (“LMR”) sites during the nine months ended September 30, 2026. The commercial potential of and our ability to successfully commercialize WiSE is unproven and will require, among other things, effective sales, marketing, manufacturing, distribution, information systems and pricing strategies, as well as compliance with applicable laws and regulations.

Previous wording

Since inception, we have incurred significant net losses and expect to continue to incur net losses until we are able to generate sufficient revenue. Since our inception, our operations have been financed primarily by net proceeds from the sale of our CDIs, common stock, convertible preferred stock, and indebtedness. As of June 30, 2026, we had $86.9 million in cash, cash equivalents, and marketable securities and an accumulated deficit of $436.7 million. For a more comprehensive discussion see “Liquidity and Capital Resources” and “Future Funding Requirements” below.

Current wording

Since inception, we have incurred significant net losses and expect to continue to incur net losses until we are able to generate sufficient revenue. Since our inception, our operations have been financed primarily by net proceeds from the sale of our CDIs, common stock, convertible preferred stock, and indebtedness. As of September 30, 2026, we had $93.2 million in cash, cash equivalents, and marketable securities and an accumulated deficit of $453.4 million. For a more comprehensive discussion see “Liquidity and Capital Resources” and “Future Funding Requirements” below.

Previous wording

In June 2026, the Company completed a fully underwritten institutional placement to institutional and sophisticated investors (“Institutional Placement”), comprising: (a) an institutional placement to institutional and sophisticated investors (“Tranche 1”); and (b) a conditional placement to BCP3 Pty Ltd, a related party of Dr. Chris Nave, a non-executive director of the Company, subject to shareholder approval at a Special Meeting of Stockholders to be held on August 18, 2026 (“Tranche 2”). Under the Tranche 1 Institutional Placement, we issued 77,352,890 CDIs, representing 7,735,289 shares of common stock, at a purchase price of A$0.38 per CDI (A$3.80 per share of common stock), for proceeds of $19.5 million, net of $1.2 million of related issuance costs. Subject to shareholder approval, the Company will issue 92,105,270 CDIs, representing 9,210,527 shares of common stock, at a purchase price of A$0.38 per CDI (A$3.80 per share of common stock), no later than thirty days from the date of the Special Meeting of Stockholders.

Current wording

In June 2026, the Company completed a fully underwritten institutional placement to institutional and sophisticated investors (“Institutional Placement”), comprising: (a) an institutional placement to institutional and sophisticated investors (“Tranche 1”); and (b) a conditional placement to BCP3 Pty Ltd, a related party of Dr. Chris Nave, a non-executive director of the Company, which was approved by stockholders at the Special Meeting of Stockholders held on August 18, 2026 (“Tranche 2”). Under the Tranche 1 Institutional Placement, we issued 77,352,890 CDIs, representing 7,735,289 shares of common stock, at a purchase price of A$0.38 per CDI (A$3.80 per share of common stock), for proceeds of $19.5 million, net of $1.2 million of related issuance costs.

Previous wording

We calculate gross margin as gross profit divided by net sales. Our gross margin has been and will continue to be affected by a variety of factors, primarily by our manufacturing costs, pricing, and the use of inventory that was previously expensed during our clinical trial. Our gross margin is expected to decrease over the near term as we continue to utilize inventory that was previously expensed as research and development costs, but over the long term our gross margin may increase to the extent our production volume increases as our fixed manufacturing costs would be spread over a larger number of units, thereby reducing our per-unit manufacturing costs. We expect our gross margin will fluctuate from period to period based upon the factors described above.

Current wording

We calculate gross margin as gross profit divided by net sales. Our gross margin has been and will continue to be affected by a variety of factors, primarily by our manufacturing costs, pricing, and the use of inventory that was previously expensed during our clinical trial, although we have fully utilized inventory that was previously expensed and going forward will receive no additional benefit to gross margin. Over the long term our gross margin may increase to the extent our production volume increases as our fixed manufacturing costs would be spread over a larger number of units, thereby reducing our per-unit manufacturing costs. We expect our gross margin will fluctuate from period to period based upon the factors described above.

Previous wording

We recorded a net loss of $17.5 million in the three months ended June 30, 2026, an increase of $5.5 million, or 45.8%, from the three months ended June 30, 2025. The increased loss in 2026 was due to an increase in selling, general and administrative expenses, and research and development expenses, as discussed below. Other expense, net also increased in 2026 primarily due to a decrease in interest income, as discussed below.

Current wording

We recorded a net loss of $16.6 million in the three months ended September 30, 2026, an increase of $4.5 million, or 36.5%, from the three months ended September 30, 2025. The increased loss in 2026 was due to an increase in selling, general and administrative expenses, and research and development expenses, as discussed below. Other expense, net also increased in 2026 primarily due to a decrease in other income, as discussed below.

Previous wording

Net sales and cost of goods sold was $2.6 million and $2.3 million, respectively, during the three months ended June 30, 2026, resulting from the Company completing commercial implants at twenty-three hospitals in the US. Net sales and cost of goods sold were significantly lower during the three months ended June 30, 2025, resulting from then-recent FDA approval of our WiSE CRT System in April 2025. During the three months ended June 30, 2025, we had commercial implants at three hospitals in the US.

Current wording

Net sales and cost of goods sold was $2.5 million and $2.2 million, respectively, during the three months ended September 30, 2026, resulting from the Company completing commercial implants at twenty-four hospitals in the US. Net sales and cost of goods sold were significantly lower during the three months ended September 30, 2025, resulting from the then-recent FDA approval of our WiSE CRT System in April 2025. During the three months ended September 30, 2025, we had commercial implants at four hospitals in the US.

Previous wording

Gross profit increased by $0.3 million, or 303.5% during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, resulting from an increase in sales volume and a higher average selling price. Our gross margin was positively affected and will continue to be affected in the near future by the use of inventory that was previously expensed during our clinical trial, although the benefit continues to decrease over time as previously expensed inventory is utilized. Gross margin was 13.0% for the three months ended June 30, 2026, compared to 50% for the three months ended June 30, 2025. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 16.9% for the three months ended June 30, 2026, compared to a negative gross margin of 51.2% for the three months ended June 30, 2025. The improvement in gross margin, excluding the use of previously expensed inventory, is the result of a higher average selling price, a lower standard cost, and increased manufacturing efficiencies during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.

Current wording

Gross profit increased by $0.03 million, or 11.2% during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, resulting from an increase in sales volume and a higher average selling price. Our gross margin was positively affected by the use of inventory that was previously expensed during our clinical trial, although we have fully utilized inventory that was previously expensed and going forward will receive no additional benefit to gross margin. Gross margin was 10.0% for the three months ended September 30, 2026, compared to 43.8% for the three months ended September 30, 2025. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 8.9% for the three months ended September 30, 2026, compared to a negative gross margin of 25.2% for the three months ended September 30, 2025. The improvement in gross margin, excluding the use of previously expensed inventory, is the result of a higher average selling price, and increased manufacturing efficiencies during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025.

Previous wording

Research and development expenses increased by $1.7 million, or 14.7%, during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. Clinical expenses increased by $0.8 million as a result of higher expenses related to WiSE CRT post-approval study. Facility-related expenses and depreciation increased by $0.6 million, as a result of our expansion of research and development activities. Quality assurance and contract manufacturing expenses increased by $0.5 million primarily due to expenses incurred to support product development activities. These increases were partially offset by a $0.2 million decrease in personnel-related expenses due to an increase in capitalized labor costs during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

Current wording

Research and development expenses increased by $0.5 million, or 7.3%, during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. Clinical expenses increased by $0.4 million as a result of higher expenses related to WiSE CRT post-approval study. Facility-related expenses and depreciation increased by $0.7 million as a result of our new laboratory in Santa Clara, CA. Quality assurance expenses increased by $0.1 million due to expenses incurred to support product development projects. These increases were offset by $0.7 million decrease in personnel-related expenses due to the reallocation of employees from research and development to selling and manufacturing activities, as a result of the shift in business focus towards commercialization during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025.

Previous wording

Selling, General and administrative expenses increased by $4.9 million, or 92.2%, during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $2.7 million as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Travel-related expenses increased by $1.2 million due to increased travel to support our sales and marketing efforts. Professional fees increased by $0.3 million, primarily resulting from higher legal fees and service fees related to the reverse stock split discussed in Note 1 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. Corporate expenses increased by $0.2 million, primarily resulting from the higher expenses related to investor relations, and computer software licenses. Facility related and other expenses increased by $0.5 million, primarily resulting from the higher expenses for our new corporate headquarters and manufacturing facility.

Current wording

Selling, General and administrative expenses increased by $3.9 million, or 67.2%, during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $2.4 million as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Travel-related expenses increased by $0.8 million due to increased travel to support our sales and marketing efforts. Professional fees increased by $0.4 million, primarily resulting from higher legal fees. Corporate expenses increased by $0.2 million, primarily resulting from the higher expenses related to investor relations, insurance premiums, and computer software licenses. Facility related and other expenses increased by $0.1 million, primarily resulting from the higher expenses for our new corporate headquarters and manufacturing facility.

Previous wording

Other expense, net increased by $0.2 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. This increase primarily resulted from a $0.3 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities, which was partially offset by a $0.1 million decrease in interest expense.

Current wording

Other expense, net increased by $0.1 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. This increase was primarily due to a $0.2 million decrease in other income from refundable tax incentives, which was partially offset by a $0.1 million decrease in interest expense.

Previous wording

Comparison of the Six Months Ended June 30, 2026, to the Six Months Ended June 30, 2025

Current wording

Comparison of the Nine Months Ended September 30, 2026, to the Nine Months Ended September 30, 2025

Previous wording

We recorded a net loss of $34.5 million in the six months ended June 30, 2026, an increase of $12.0 million, or 53.3%, from the six months ended June 30, 2025. The increased loss in 2026 was due to an increase in selling, general and administrative expenses, and research and development expenses, as discussed below. Other expense, net also increased in 2026 primarily due to a decrease in interest income, as discussed below.

Current wording

We recorded a net loss of $51.2 million in the nine months ended September 30, 2026, an increase of $16.5 million, or 47.4%, from the nine months ended September 30, 2025. The increased loss in 2026 was due to an increase in selling, general and administrative expenses, and research and development expenses, as discussed below. Other expense, net also increased in 2026 primarily due to a decrease in interest income, as discussed below.

Previous wording

The following table summarizes our operating results for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our operating results for the nine months ended September 30, 2026 and 2025:

Previous wording

Net sales and cost of goods sold was $5.0 million and $4.5 million, respectively, during the six months ended June 30, 2026, resulting from the Company completing commercial implants at twenty-nine hospitals in the US. Net sales and cost of goods sold were significantly lower during the six months ended June 30, 2025, resulting from then-recent FDA approval of our WiSE CRT System in April 2025. During the six months ended June 30, 2025, we had commercial implants at three hospitals in the US.

Current wording

Net sales and cost of goods sold was $7.5 million and $6.7 million, respectively, during the nine months ended September 30, 2026, resulting from the Company completing commercial implants at forty-one hospitals in the US. Net sales and cost of goods sold were significantly lower during the nine months ended September 30, 2025, resulting from the then-recent FDA approval of our WiSE CRT System in April 2025. During the nine months ended September 30, 2025, we had commercial implants at seven hospitals in the US.

Previous wording

Gross profit increased by $0.4 million, or 520.0% for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, resulting from an increase in sales volume and a higher average selling price. Our gross margin was positively affected and will continue to be affected in the near future by the use of inventory that was previously expensed during our clinical trial, although the benefit continues to decrease over time as previously expensed inventory is utilized. Gross margin was 10.5% for the six months ended June 30, 2026, compared to 50% for the six months ended June 30, 2025. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 20.90% and 51.18% for the six months ended June 30, 2026 and 2025, respectively. The improvement in gross margin, excluding the use of previously expensed inventory, is the result of a higher average selling price, a lower standard cost, and increased manufacturing efficiencies during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

Current wording

Gross profit increased by $0.5 million, or 151.9% for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, resulting from an increase in sales volume and a higher average selling price. Our gross margin was positively affected by the use of inventory that was previously expensed during our clinical trial, although we have fully utilized inventory that was previously expensed and going forward will receive no additional benefit to gross margin. Gross margin was 10.4% for the nine months ended September 30, 2026, compared to 45.2% for the nine months ended September 30, 2025. Excluding the use of previously expensed inventory, we would have had a negative gross margin of 16.9% for the nine months ended September 30, 2026, compared to a negative gross margin of 31.9% for the nine months ended September 30, 2025. The improvement in gross margin, excluding the use of previously expensed inventory, is the result of a higher average selling price, and increased manufacturing efficiencies during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025.

Previous wording

Research and development expenses increased by $0.7 million, or 11.2%, during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. Clinical expenses increased by $0.6 million as a result of higher expenses related to WiSE CRT post-approval study. Facility-related expenses and depreciation increased by $0.3 million in support of our continuing expansion of research and development activities. These increases were offset by $0.2 million decrease in personnel-related expenses due to an increase in capitalized labor costs during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.

Current wording

Research and development expenses increased by $2.1 million, or 12.0%, during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. Clinical expenses increased by $1.2 million as a result of higher expenses related to WiSE CRT post-approval study. Facility-related expenses and depreciation increased by $1.2 million, as a result of our new laboratory in Santa Clara, CA. Quality assurance expenses increased by $0.4 million and contract manufacturing expenses increased by $0.2 million primarily due to higher expenses incurred to support product development projects. These increases were partially offset by a $0.9 million decrease in personnel-related expenses due to the reallocation of employees from research and development to selling and manufacturing activities, as a result of the shift in business focus towards commercialization during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025.

Previous wording

Selling, General and administrative expenses increased by $10.4 million, or 108.3%, during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $5.5 million, as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Travel-related expenses increased by $2.9 million due to increased travel to support our sales and marketing efforts. Professional fees increased by $0.7 million, primarily resulting from higher legal and consulting services fees. Corporate expenses increased by $0.5 million, primarily resulting from the higher expenses related to insurance premiums, investor relations, and computer software licenses. Facility related and other expenses increased by $0.8 million, primarily resulting from the higher expenses for our new corporate headquarters and manufacturing facility.

Current wording

Selling, General and administrative expenses increased by $14.4 million, or 92.8%, during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. Personnel-related expenses including salaries, bonuses, stock-based compensation and certain fringe benefits increased by $7.9 million, as a result of the expansion of our workforce to support increased adoption of our WiSE CRT System. Travel-related expenses increased by $3.7 million due to increased travel to support our sales and marketing efforts. Professional fees increased by $1.2 million, primarily resulting from higher legal and consulting services fees. Corporate expenses increased by $0.7 million, primarily resulting from the higher expenses related to insurance premiums, investor relations, and computer software licenses. Facility related and other expenses increased by $0.9 million, primarily resulting from the higher expenses for our new corporate headquarters and manufacturing facility.

Previous wording

Other expense, net increased by $0.3 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. This increase primarily resulted from a $0.5 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities, which was partially offset by a $0.2 million decrease in interest expense.

Current wording

Other expense, net increased by $0.4 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. This increase primarily resulted from a $0.5 million decrease in interest income earned on investments in marketable securities, including the accretion of discounts on marketable securities, and a $0.2 million decrease in other income from refundable tax incentives, which were partially offset by a $0.3 million decrease in interest expense.

Previous wording

We manage our cash and capital structure to maximize shareholder return, maintain our financial condition, and maintain flexibility for future strategic initiatives. We continuously assess our working capital needs, debt and leverage levels, debt maturity schedule, capital expenditure requirements and future investments. As of June 30, 2026 and December 31, 2025, we had approximately $86.9 million and $54.2 million, respectively, in cash, cash equivalents, and marketable securities. Based on our cash, cash equivalents, and marketable securities as of June 30, 2026, and our expectation to generate operating losses, negative operating cash flows in the foreseeable future, and the repayment of notes payable, there exists substantial doubt regarding our ability to continue as a going concern for a period of at least twelve months from the date of this Form 10-Q.

Current wording

We manage our cash and capital structure to maximize shareholder return, maintain our financial condition, and maintain flexibility for future strategic initiatives. We continuously assess our working capital needs, debt and leverage levels, debt maturity schedule, capital expenditure requirements and future investments. As of September 30, 2026 and December 31, 2025, we had approximately $93.2 million and $54.2 million, respectively, in cash, cash equivalents, and marketable securities. Based on our cash, cash equivalents, and marketable securities as of September 30, 2026, and our expectation to generate operating losses, negative operating cash flows in the foreseeable future, and the repayment of notes payable, there exists substantial doubt regarding our ability to continue as a going concern for a period of at least twelve months from the date of this Form 10-Q.

Previous wording

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. For the six months ended June 30, 2026 and 2025, we incurred a net loss of $34.5 million and $22.5 million, respectively. During the six months ended June 30, 2026 and 2025, we had negative cash flows from operations of $37.4 million and $25.0 million, respectively. As of June 30, 2026, we had working capital of $58.1 million and accumulated deficit of $436.7 million. Additionally, the Company has $41.8 million of debt obligations coming due within the next twelve months. These factors raise substantial doubt about our ability to continue as a going concern. Until we are able to generate consistent and sufficient revenue from sales of our WiSE CRT System, our ability to continue as a going concern is dependent on our ability to raise additional capital through the issuance of additional common stock or borrowings from financial institutions. The Company has received an irrevocable commitment to purchase 92,105,270 CDIs, representing 9,210,527 shares of common stock, at a purchase price of $0.38 Australian dollars (“A$”) per CDI (A$3.80 per share of common stock), from BCP3 Pty Ltd, a related party of Dr. Chris Nave, a non-executive director of the Company, subject to shareholder approval at the Special Meeting of Stockholders to be held on August 18, 2026. In addition, the Company expects to refinance its long-term debt obligations prior to scheduled maturity date. Our ability to obtain additional financing is subject to several factors, including market and economic conditions, our performance, and investor sentiment with respect to our company and our industry, however no assurance can be given as to whether additional needed financing will be available on terms acceptable to the Company, or at all.

Current wording

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities during the normal course of business. For the nine months ended September 30, 2026 and 2025, we incurred a net loss of $51.2 million and $34.7 million, respectively. During the nine months ended September 30, 2026 and 2025, we had negative cash flows from operations of $54.7 million and $38.2 million, respectively. As of September 30, 2026, we had working capital of $58.3 million and accumulated deficit of $453.4 million. Additionally, the Company has $41.8 million of debt obligations coming due within the next twelve months. These factors raise substantial doubt about our ability to continue as a going concern. Until we are able to generate consistent and sufficient revenue from sales of our WiSE CRT System, our ability to continue as a going concern is dependent on our ability to raise additional capital through the issuance of additional common stock or borrowings from financial institutions. Our ability to obtain additional financing is subject to several factors, including market and economic conditions, our performance, and investor sentiment with respect to our company and our industry, however no assurance can be given as to whether additional needed financing will be available on terms acceptable to the Company, or at all.

Previous wording

As of June 30, 2026, we had $0.3 million in operating lease obligations for our corporate headquarters and laboratory space located in Sunnyvale, California. Additionally, in January 2025, we entered into a new lease agreement for our new corporate headquarters, laboratory and manufacturing facility in Santa Clara, California, for which we had recorded $18.2 million in operating lease obligations as of June 30, 2026.

Current wording

As of September 30, 2026, we had $0.2 million in operating lease obligations for our corporate headquarters and laboratory space located in Sunnyvale, California. Additionally, in January 2025, we entered into a new lease agreement for our new corporate headquarters, laboratory and manufacturing facility in Santa Clara, California, for which we had recorded $18.3 million in operating lease obligations as of September 30, 2026.

Previous wording

In addition, we have agreements with suppliers and other parties to purchase inventory. Product inventory obligations consist primarily of purchase order commitments for raw materials and sub-assemblies used in the production of the WiSE CRT System. In certain instances, our purchase agreements allow us to cancel, reschedule, or adjust our purchase requirements based on our business needs prior to firm orders being placed. As of June 30, 2026, our obligations under such arrangements were approximately $10.6 million.

Current wording

In addition, we have agreements with suppliers and other parties to purchase inventory. Product inventory obligations consist primarily of purchase order commitments for raw materials and sub-assemblies used in the production of the WiSE CRT System. In certain instances, our purchase agreements allow us to cancel, reschedule, or adjust our purchase requirements based on our business needs prior to firm orders being placed. As of September 30, 2026, our obligations under such arrangements were approximately $14.0 million.

Previous wording

As of June 30, 2026, we had working capital of $58.1 million, comprised of current assets of $110.1 million and current liabilities of $52.0 million. Current assets, consisting of cash and cash equivalents, marketable securities, accounts and other receivables, inventory, prepaid expenses, and other current assets, increased by $37.0 million as of June 30, 2026, compared to December 31, 2025. The recent capital raise completed in June 2026 contributed to the overall increase in cash, cash equivalents and marketable securities, resulting in a $32.8 million increase in working capital as of June 30, 2026. The capitalization of inventory resulted in a $3.8 million increase in working capital. A $0.5 million increase in accounts receivable was primarily due to a $1.0 million increase in amounts outstanding from customers and contract manufacturers, offset by a $0.5 million decrease accounts receivable from reimbursements for leasehold improvements. Additionally, a $0.8 million increase in other current assets, primarily due to an increase in deferred costs of goods sold, which was offset by a $0.9 million decrease in prepaid expenses attributable to higher amortization of prepaid expenses in 2026, resulted in a $0.1 million decrease in working capital as of June 30, 2026.

Current wording

As of September 30, 2026, we had working capital of $58.3 million, comprised of current assets of $110.8 million and current liabilities of $52.5 million. Current assets, consisting of cash and cash equivalents, marketable securities, accounts and other receivables, inventory, prepaid expenses, and other current assets, increased by $37.7 million as of September 30, 2026, compared to December 31, 2025. The capital raises completed in 2026 contributed to the overall increase in cash, cash equivalents and marketable securities, resulting in a $32.2 million increase in working capital as of September 30, 2026. The capitalization of inventory resulted in a $5.1 million increase in working capital. A $0.4 million increase in accounts receivable was primarily due to a $2.1 million increase in amounts outstanding from customers and contract manufacturers, offset by a $1.7 million decrease accounts receivable from reimbursements for leasehold improvements. Additionally, a $1.2 million increase in other current assets, primarily due to an increase in deferred costs of goods sold, was offset by a $1.2 million decrease in prepaid expenses attributable to higher amortization of prepaid expenses in 2026.

Previous wording

Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, interest payable, and current portion of notes payable increased by approximately $38.0 million as of June 30, 2026, compared to December 31, 2025. The increase primarily resulted from a $41.2 million increase in notes payable which was reclassified into current liability, as it becomes due within the next twelve months. This increase was partially offset by a $3.1 million decrease in accounts payable and accrued expenses, which were mainly due to the activity related to construction of leasehold improvements at the new corporate headquarters and purchases of raw materials, and a $0.1 million decrease in operating lease liabilities.

Current wording

Current liabilities, consisting primarily of accounts payable, accrued liabilities, lease obligations, interest payable, and current portion of notes payable increased by approximately $38.5 million as of September 30, 2026, compared to December 31, 2025. The increase primarily resulted from a $41.4 million increase in notes payable which was reclassified into current liability, as it becomes due within the next twelve months. This increase was partially offset by a $2.7 million decrease in accounts payable and accrued expenses, which were mainly due to the activity related to construction of leasehold improvements at the new corporate headquarters and purchases of raw materials, and a $0.2 million decrease in operating lease liabilities.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025:

Previous wording

Net cash used in operating activities during the six months ended June 30, 2026, was $37.4 million, compared to $25.0 million during the six months ended June 30, 2025, representing an increase in use of $12.4 million. This increase is primarily attributed to an increase in net loss of $12.0 million and an increase in use of cash from changes in working capital of $1.4 million, which were partially offset by an increase in non-cash adjustments of $1.0 million.

Current wording

Net cash used in operating activities during the nine months ended September 30, 2026, was $54.7 million, compared to $38.2 million during the nine months ended September 30, 2025, representing an increase in use of $16.5 million. This increase is primarily attributed to an increase in net loss of $16.5 million and an increase in use of cash from changes in working capital of $1.2 million, which were partially offset by an increase in non-cash adjustments of $1.2 million.

Previous wording

Net cash provided by investing activities during the six months ended June 30, 2026, was $14.7 million, compared to $18.8 million during the six months ended June 30, 2025, representing a decrease in cash provided of $4.1 million. The decrease was attributable to a $12.8 million increase in the purchase of marketable securities, as well as a $5.2 million increase in purchases of property and equipment during the six months ended June 30, 2026, as compared to the six months ended June 30, 2026. These increases in cash used for investing activities were partially offset by a $13.9 million increase in cash from the maturities and sales of marketable securities during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

Current wording

Net cash used by investing activities during the nine months ended September 30, 2026, was $36.8 million, compared to $0.3 million during the nine months ended September 30, 2025, representing an increase in cash used of $36.5 million. The increase was attributable to a $32.3 million increase in the purchase of marketable securities, as well as a $4.0 million increase in purchases of property and equipment during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2026. In addition, cash provided from the maturities and sales of marketable securities decreased by $0.2 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025.

Previous wording

Net cash provided by financing activities during the six months ended June 30, 2026 was $76.3 million, compared to $46.9 million during the six months ended June 30, 2025, representing an increase of $29.4 million. This increase was primarily attributed to the $29.7 million increase in proceeds from a capital raise, net of issuance cost, during the six months ended June 30, 2026, which was partially offset by a $0.3 million decrease in proceeds from exercise of stock options during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.

Current wording

Net cash provided by financing activities during the nine months ended September 30, 2026 was $99.7 million, compared to $46.8 million during the nine months ended September 30, 2025, representing an increase of $52.9 million. This increase was primarily attributed to the $53.3 million increase in proceeds from a capital raise, net of issuance cost, during the nine months ended September 30, 2026, which was partially offset by a $0.4 million decrease in proceeds from exercise of stock options during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025.