InspireMD, Inc.

Previous wording

Following such approval, in July 2025, we announced the official commercial launch of the the CGuard Prime Carotid Stent System in the United States. In October 2024, we established our global headquarters in Miami, Florida to support the U.S. launch and commercialization of CGuard Prime Carotid Stent System.

Current wording

Following such approval, in July 2025, we announced the official commercial launch of the CGuard Prime Carotid Stent System in the United States. In October 2024, we established our global headquarters in Miami, Florida to support the U.S. launch and commercialization of CGuard Prime Carotid Stent System.

Previous wording

Exercise of Series I Warrant s

Current wording

Exercise of Series I Warrants

Previous wording

On July 30, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with investors pursuant to which the Company issued and sold in a private placement (the “Private Placement Offering”) an aggregate of 6,791,380 shares (the “Private Placement Shares”) of common stock and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 9,764,804 shares of common stock, at an offering price of $2.42 per Private Placement Shares and $2.4199 per Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full. Certain of the Company’s directors participated in the Private Placement Offering. The Private Placement Offering closed on August 1, 2025.

Current wording

On July 30, 2025, the Company entered into a securities purchase agreement with investors pursuant to which the Company issued and sold in a private placement (the “Private Placement Offering”) an aggregate of 6,791,380 shares (the “Private Placement Shares”) of common stock and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 9,764,804 shares of common stock, at an offering price of $2.42 per Private Placement Share and $2.4199 per Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full. Certain of the Company’s directors participated in the Private Placement Offering. The Private Placement Offering closed on August 1, 2025.

Previous wording

Aggregate gross proceeds to the Company in respect of the Private Placement Offering were approximately $40.1 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company.

Current wording

Aggregate gross proceeds to the Company in respect of the Private Placement Offering were approximately $40.1 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company. In addition, the Company paid the placement agent for the offering a placement fee equal to 6.0% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and expense reimbursement of $75,000.

Previous wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $113,000 increase in Latin America, a $39,000 increase in Asia, both due to continued adoption of our CGuard technology, and a $11,000 increase in North America due to sales in the United States related to stents used in our CGUARDIANS II pivotal study. This increase was offset by a $121,000 decrease in Europe and a $3,000 decrease in other territories driven by reasons mentioned above.

Current wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $490,000 increase in North America due to the official commercial launch of CGuard Prime in the U.S. following FDA approval in June 2025, and a $223,000 increase in international markets outside North America due to continued adoption of our CGuard technology.

Previous wording

Gross Profit. For the three months ended June 30, 2025, gross profit (revenue less cost of revenues) decreased by $18,000, or 5.4%, to $313,000, from $331,000 during the three months ended June 30, 2024. This decrease in gross profit resulted from an increase in write-offs and miscellaneous expense of $111,000, partially offset by the gross profit generated from the $93,000 increase in revenue (net of associated material and labor costs). Gross margin (gross profits as a percentage of revenue) decreased to 17.6% during the three months ended June 30, 2025, from 19.0% during the three months ended June 30, 2024, driven by the reasons mentioned above.

Current wording

Gross Profit. For the three months ended September 30, 2025, gross profit (revenue less cost of revenues) increased by $450,000, or 108.7%, to $864,000 from $414,000 during the three months ended September 30, 2024. This increase in gross profit resulted from a $529,000 increase in revenues, less the associated material and labor costs and was augmented by the contribution of revenue from direct sales in the U.S., which carry higher unit profit due to higher average selling price per unit, as compared to international sales through distributors. The increase in gross profit was partially offset by an increase in manufacturing and miscellaneous expenses of $79,000. Gross margin (gross profit as a percentage of revenue) increased to 34.2% during the three months ended September 30, 2025, from 22.9% during the three months ended September 30, 2024, driven by the factors mentioned above.

Previous wording

Research and Development Expenses. For the three months ended June 30, 2025, research and development expenses increased by $433,000, or 12.7%, to $3,834,000, from $3,401,000 during the three months ended June 30, 2024. This increase resulted primarily due to an increase in compensation expenses of $417,000 due to hiring of new employees in connection with our expansion in the United States and an increase of $16,000 in miscellaneous expenses.

Current wording

Research and Development Expenses. For the three months ended September 30, 2025, research and development expenses decreased by $280,000, or 7.2%, to $3,635,000, from $3,915,000 during the three months ended September 30, 2024. This decrease resulted primarily due to the completion of the C-GUARDIANS clinical study and related product preparation expense prior to the FDA approval of the CGuard Prime product in June 2025, partially offset by an increase in compensation expenses due to hiring of new employees in connection with our expansion in the U.S.

Previous wording

Selling and Marketing Expenses. For the three months ended June 30, 2025, selling and marketing expenses increased by $2,727,000, or 188.7%, to $4,172,000 from $1,445,000 during the three months ended June 30, 2024. This increase resulted primarily from an increase in compensation expenses of $2,317,000 and related travel expenses of $267,000 as the Company continued to build its U.S. commercial infrastructure in connection with FDA approval for CGuard Prime and the commercial launch in the United States and an increase of $143,000 in miscellaneous expenses.

Current wording

Selling and Marketing Expenses. For the three months ended September 30, 2025, selling and marketing expenses increased by $2,920,000, or 198.4%, to $4,392,000 from $1,472,000 during the three months ended September 30, 2024. This increase resulted primarily from an increase in compensation and headcount related expenses from higher commercial staffing levels in connection with the commercial launch of CGuard Prime in the U.S.

Previous wording

General and Administrative Expenses. For the three months ended June 30, 2025, general and administrative expenses increased by $1,581,000, or 42.2%, to $5,326,000, from $3,745,000 during the three months ended June 30, 2024. The increase was primarily driven by a $1,119,000 increase in compensation expenses and related accruals, mainly due to new hires for our U.S. headquarters, salary increases and expected severance payments accrued as a result of our former chief financial officer’s announced retirement, a $98,000 increase for rent expenses, mainly related to our U.S. headquarters, and an increase of $364,000 in miscellaneous expenses.

Current wording

General and Administrative Expenses. For the three months ended September 30, 2025, general and administrative expenses increased by $2,399,000, or 68.8%, to $5,888,000, from $3,489,000 during the three months ended September 30, 2024. The increase was primarily driven by higher compensation and headcount related expenses from new hires to support the Company’s expansion of U.S. operations. General and administrative expenses were also higher due to an increase in professional services and miscellaneous expenses to support the expansion of U.S. operations following the commercial launch of CGuard Prime.

Previous wording

Financial Income (Expenses). For the three months ended June 30, 2025, financial income decreased by $483,000 to $132,000 of financial expenses, from $351,000 of financial income during the three months ended June 30, 2024. The decrease in financial income primarily resulted from a $313,000 increase in financial expenses related to changes in exchange rates and a $169,000 decrease in financial income from investment in marketable securities and money market funds.

Current wording

Financial Income. For the three months ended September 30, 2025, financial income decreased by $229,000 or 40.0% to $343,000, from $572,000 during the three months ended September 30, 2024. The decrease in financial income primarily resulted from a $118,000 decrease in financial income from investment in marketable securities and money market funds due to lower interest rates and a $104,000 increase in financial expenses related to changes in exchange rates.

Previous wording

Net Loss. Our net loss increased by $5,242,000, or 66.3%, to $13,151,000, for the three months ended June 30, 2025, from $7,909,000 during the three months ended June 30, 2024. The increase in net loss resulted primarily from an increase of $4,741,000 in operating expenses.

Current wording

Net Loss. Our net loss increased by $4,818,000, or 61.1%, to $12,708,000, for the three months ended September 30, 2025, from $7,890,000 during the three months ended September 30, 2024. The increase in net loss resulted primarily from an increase of $5,039,000 in operating expenses.

Previous wording

Gross Profit. For the six months ended June 30, 2025, gross profit (revenue less cost of revenues) decreased by $18,000, or 2.8%, to $605,000, compared to $623,000 for the same period in 2024. Gross margin (gross profit as a percentage of revenue) decreased to 18.3% for the six months ended June 30, 2025, from 19.2% for the six months ended June 30, 2024, driven by the factors mentioned above.

Current wording

Gross Profit. For the nine months ended September 30, 2025, gross profit (revenue less cost of revenues) increased by $432,000, or 41.7%, to $1,469,000, compared to $1,037,000 for the same period in 2024. This increase in gross profit resulted from a $589,000 increase in revenues, less the associated material and labor costs and was augmented by the contribution of revenue from direct sales in the U.S., which carry higher unit profit due to higher average selling price per unit, as compared to international sales through distributors. The increase in gross profit was partially offset by an increase in manufacturing and miscellaneous expenses of $157,000. Gross margin (gross profit as a percentage of revenue) increased to 25.2% for the nine months ended September 30, 2025, from 20.5% for the nine months ended September 30, 2024, driven by the factors mentioned above.

Previous wording

Research and Development Expenses. For the six months ended June 30, 2025, research and development expenses increased by 31.0%, or $1,867,000 to $7,893,000, from $6,026,000 during the six months ended June 30, 2024. This increase resulted primarily due to an increase of $932,000 of SwitchGuard NPS development and regulatory approval process including expenses related to CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System, an increase in compensation expenses of $786,000 due to hiring of new employees in connection with our expansion in the United States and due to an increase of share-based compensation-related expenses and an increase of $149,000 in miscellaneous expenses.

Current wording

Research and Development Expenses. For the nine months ended September 30, 2025, research and development expenses increased by 16.0%, or $1,587,000 to $11,528,000, from $9,941,000 during the nine months ended September 30, 2024. This increase resulted primarily due to an increase in compensation and headcount related expenses due to higher staff levels in connection with our expansion in the United States, and higher development and regulatory expenses for of the SwitchGuard NPS and CGuard Prime 80cm Carotid Stent System, respectively. These increases were partially offset by a decrease of expenses for the C-GUARDIANS clinical study, which was completed prior to the approval by the FDA in June 2025.

Previous wording

Selling and Marketing Expenses. For the six months ended June 30, 2025, selling and marketing expenses increased by 158.1%, or $4,240,000, to $6,922,000, from $2,682,000 during the six months ended June 30, 2024. This increase resulted primarily from an increase in compensation expenses of $3,440,000 and related travel expenses of $396,000 as the Company continued to build its U.S. commercial infrastructure in connection with FDA approval for CGuard Prime and the commercial launch in the United States. In addition, there was an increase of $311,000 in promotional activities and an increase of $93,000 in miscellaneous expenses.

Current wording

Selling and Marketing Expenses. For the nine months ended September 30, 2025, selling and marketing expenses increased by $7,160,000, or 172.4%, to $11,314,000, from $4,154,000 during the nine months ended September 30, 2024. This increase resulted primarily from an increase in compensation and headcount related expenses from higher commercial staffing levels in connection with the commercial launch of CGuard Prime in the U.S.

Previous wording

Financial Income. For the six months ended June 30, 2025, financial income decreased by $571,000, to $162,000 of financial income, from $733,000 of financial income during the six months ended June 30, 2024. The decrease in financial income primarily resulted from a $280,000 decrease in income from investment in marketable securities and money market funds and a $292,000 increase in financial expenses related to changes in exchange rates

Current wording

Financial Income. For the nine months ended September 30, 2025, financial income decreased by $800,000, to $505,000 of financial income, from $1,305,000 of financial income during the nine months ended September 30, 2024. The decrease in financial income primarily resulted from a $398,000 decrease in income from investment in marketable securities and money market funds due to lower interest rates and a $393,000 increase in financial expenses related to changes in exchange rates.

Previous wording

Tax Expenses. For the six months ended June 30, 2025, there was no material change in our tax expenses as compared to the six months ended June 30, 2024.

Current wording

Tax Expenses. For the nine months ended September 30, 2025, there was no material change in our tax expenses as compared to the nine months ended September 30, 2024.

Previous wording

Net Loss. Our net loss increased by $9,376,000, or 62.8%, to $24,317,000, for the six months ended June 30, 2025, from $14,941,000 during the six months ended June 30, 2024. The increase in net loss resulted primarily from an increase of $8,787,000 in operating expenses and a decrease of $571,000 in financial income.

Current wording

Net Loss. Our net loss increased by $14,194,000, or 62.2%, to $37,025,000, for the nine months ended September 30, 2025, from $22,831,000 during the nine months ended September 30, 2024. The increase in net loss resulted primarily from an increase of $13,826,000 in operating expenses.

Previous wording

We had an accumulated deficit as of June 30, 2025, of $278 million, as well as a net loss of $24.3 million and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard Prime, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.

Current wording

We had an accumulated deficit as of September 30, 2025, of $291 million, as well as a net loss of $37.0 million for the nine months ended September 30, 2025 and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard Prime, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.

Previous wording

In May 2024, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as sales agent (“Piper Sandler), pursuant to which we may offer and sell, from time to time, at our option, through or to Piper Sandler up to $75,000,000 of our common stock (the “ATM Program”). As of the issuance date of this report, we have sold 920,898 shares of our common stock for total gross proceeds of approximately $2,396 thousands under the ATM Program.

Current wording

In May 2024, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as sales agent (“Piper Sandler), pursuant to which we may offer and sell, from time to time, at our option, through or to Piper Sandler up to $75,000,000 of our common stock (the “ATM Program”). As of the issuance date of this report, we have sold 920,898 shares of our common stock for total gross proceeds of approximately $2.4 million under the ATM Program.

Previous wording

During June and July 2025, Series I warrants to purchase 12,914,078 shares of common stock that were issued in the May 2023 private placement were exercised in full into 2,352,393 of shares of common stock and pre-funded warrants to purchase 10,561,685 shares of common stock. The net proceeds to the Company from the exercise of the Series I Warrants were $16.9 million after deducting placement agent fees.

Current wording

During June and July 2025, Series I warrants to purchase 12,914,078 shares of common stock that were issued in the May 2023 private placement were exercised in full into 2,352,393 shares of common stock and pre-funded warrants to purchase 10,561,685 shares of common stock. The net proceeds to the Company from the exercise of the Series I Warrants were $16.9 million after deducting placement agent fees.

Previous wording

General. At June 30, 2025, we had cash and cash equivalents of $11,509,000 and marketable securities of $7,865,000, as compared to cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as of December 31, 2024. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.

Current wording

General. At September 30, 2025, we had cash and cash equivalents of $63,403,000, as compared to cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as of December 31, 2024. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.

Previous wording

For the six months ended June 30, 2025, net cash used in our operating activities increased by $7,707,000, or 81.8%, to $17,125,000, from $9,418,000 during the same period in 2024. The primary reason for the increase in cash used in our operating activities was an increase of $1,826,000 in payments for third party related expenses and for professional services, an increase of $5,288,000 in compensation costs paid during the six months ended June 30, 2025 (from $6,186,000 in the six months ended June 30, 2024 to $11,474,000 in the six months ended June 30, 2025), a decrease of $346,000 in payments received from customers during the six months ended June 30, 2025 (from $3,726,000 in the six months ended June 30, 2024 to $3,380,000 during the six months ended June 30, 2025) and a decrease of $247,000 in interest income received from money market funds and marketable securities.

Current wording

For the nine months ended September 30, 2025, net cash used in our operating activities increased by $10,640,000, or 70.4%, to $25,758,000, from $15,118,000 during the same period in 2024. The primary reasons for the increase in cash used in our operating activities were an increase of $9,005,000 in compensation costs paid during the nine months ended September 30, 2025 (from $8,838,000 in the nine months ended September 30, 2024 to $17,843,000 in the nine months ended September 30, 2025) and an increase of $1,709,000 in payments for third party related expenses and for professional services.

Previous wording

Cash provided by our investing activities was $7,024,000 during the six months ended June 30, 2025, compared to $10,323,000 during the six months ended June 30, 2024. The primary reason for the decrease in cash provided by our investing activities is investment of $3,029,000, net of withdrawal in marketable securities and an increase of $265,000 in payments made for purchase of property, plant and equipment during the six months ended June 30, 2025.

Current wording

Cash provided by our investing activities was $14,575,000 during the nine months ended September 30, 2025, compared to $4,399,000 during the nine months ended September 30, 2024. The primary reason for the increase in cash provided by our investing activities is withdrawal of $10,343,000, net of investment in marketable securities.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2025, was $2,643,000. The source of the cash provided by financing activities during the six months ended June 30, 2025, were the proceeds from exercise of Series I warrants of $1,947,000, and proceeds from issuance of shares of $696,000, net of issuance costs, received from our ATM Program. Cash provided by financing activities for the six months June 30, 2024, was $17,854,000. The source of the cash provided by financing activities during the six months ended June 30, 2024, were the proceeds from exercise of Series H warrants.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2025, was $55,569,000. The source of the cash provided by financing activities during the nine months ended September 30, 2025, were the proceeds from the Private Placement Offering in July 2025 as well as proceeds from issuance of shares received from our ATM Program that resulted in approximately $38,714,000 of aggregate net proceeds and proceeds from exercise of Series I warrants of $16,855,000. Cash provided by financing activities for the nine months September 30, 2024, was $16,889,000. The source of the cash provided by financing activities during the nine months ended September 30, 2024, were the proceeds from exercise of Series H warrants.

Previous wording

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

Current wording

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the market acceptance of the U.S. commercial launch, cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

Previous wording

During the six months ended June 30, 2025, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2024.

Current wording

During the nine months ended September 30, 2025, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2024.