InspireMD Inc

Previous wording

The primary endpoint is a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events are adjudicated by an independent clinical events committee. The composite index will be compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance goal will be considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

Current wording

The primary endpoint was a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events were adjudicated by an independent clinical events committee. The composite index was compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance goal was considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

Previous wording

Revenues. For the three months ended March 31, 2024, revenue increased by $272,000, or 22.0%, to $1,511,000, from $1,239,000 during the three months ended March 31, 2023. This increase was predominantly driven by growth in existing markets.

Current wording

Revenues. For the three months ended June 30, 2024, revenue increased by $90,000, or 5.4%, to $1,739,000, from $1,649,000 during the three months ended June 30, 2023. This increase was predominantly driven by growth in existing and new markets, partially offset by a reduction in clinical trial revenue driven by the conclusion of C-GUARDIANS enrollment in June 2023.

Previous wording

Gross Profit. For the three months ended March 31, 2024, gross profit (revenue less cost of revenues) decreased by $81,000, or 21.6%, to $292,000, from $373,000 during the three months ended March 31, 2023. This decrease in gross profit resulted from a $85,000 increase in training costs for new hires to build capacity for anticipated increased volume requirements, offset by $4,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) decreased to 19.4% during the three months ended March 31, 2024, from 30.1% during the three months ended March 31, 2023, driven by the factors mentioned above.

Current wording

Gross Profit. For the three months ended June 30, 2024, gross profit (revenue less cost of revenues) decreased by $160,000, or 32.6%, to $331,000, from $491,000 during the three months ended June 30, 2023. This decrease in gross profit resulted from a $237,000 increase in material and labor costs mainly due to higher sales volume as well as compensation expense for new and current employees, additional space to build capacity for anticipated increased volume requirements and additional training expenses offset by an increase of the revenues of $90,000 (see above), and an increase $13,000 in miscellaneous expense. Gross margin (gross profits as a percentage of revenue) decreased to 19.0% during the three months ended June 30, 2024, from 29.8% during the three months ended June 30, 2023, driven by the factors mentioned above.

Previous wording

Research and Development Expenses. For the three months ended March 31, 2024, research and development expenses increased by $782,000, or 42.4%, to $2,625,000, from $1,843,000 during the three months ended March 31, 2023. This increase resulted primarily from an increase in compensation expenses of $567,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023 and the first quarter of 2024 and due to the hiring of the Executive Vice President and General Manager of North America in connection with our expansion plans in the United States, an increase of $159,000 related to an early feasibility study of CGuard Prime for the treatment of acute stroke patients with tandem lesions and an increase of $56,000 in miscellaneous expenses.

Current wording

Research and Development Expenses. For the three months ended June 30, 2024, research and development expenses increased by $1,408,000, or 70.6%, to $3,401,000, from $1,993,000 during the three months ended June 30, 2023. This increase resulted primarily from an increase in compensation expenses of $741,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made to employees and consultants since the second quarter of 2023 and due to the hiring of the Executive Vice President and General Manager of North America in connection with our expansion plans in the United States, an increase of $427,000 of SwitchGuard NPS development and regulatory approval process, an increase of $82,000 related to the establishment of operations in the United States, an increase of $77,000 related to an early feasibility study of CGuard Prime for the treatment of acute stroke patients with tandem lesions and an increase of $81,000 in miscellaneous expenses.

Previous wording

Selling and Marketing Expenses. For the three months ended March 31, 2024, selling and marketing expenses increased by $449,000, or 57.0%, to $1,237,000, from $788,000 during the three months ended March 31, 2023. This increase resulted primarily from an increase in compensation expenses of $381,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023 and the first quarter of 2024 and an increase of $68,000 in miscellaneous expenses.

Current wording

Selling and Marketing Expenses. For the three months ended June 30, 2024, selling and marketing expenses increased by $553,000, or 62.0%, to $1,445,000, from $892,000 during the three months ended June 30, 2023. This increase resulted primarily from an increase in compensation expenses of $469,000 and an increase of $84,000 in miscellaneous expenses.

Previous wording

General and Administrative Expenses. For the three months ended March 31, 2024, general and administrative expenses increased by $1,721,000, or 81.1%, to $3,844,000, from $2,123,000 during the three months ended March 31, 2023. This increase resulted primarily from an increase in compensation expenses of $1,682,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023 and the first quarter of 2024, and an increase of $39,000 in miscellaneous expenses.

Current wording

General and Administrative Expenses. For the three months ended June 30, 2024, general and administrative expenses increased by $824,000, or 28.2%, to $3,745,000, from $2,921,000 during the three months ended June 30, 2023. This increase resulted primarily from an increase in compensation expenses of $993,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants made during the second quarter of 2023 and the first quarter of 2024, offset by a decrease of $92,000 in legal expenses and a $77,000 in miscellaneous expenses.

Previous wording

Financial Income. For the three months ended March 31, 2024, financial income increased by $257,000 or 205.6%, to $382,000, from $125,000 during the three months ended March 31, 2023. The increase in financial income primarily resulted from a $264,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Current wording

Financial Income. For the three months ended June 30, 2024, financial income increased by $113,000 or 47.5%, to $351,000, from $238,000 during the three months ended June 30, 2023. The increase in financial income primarily resulted from a $123,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Previous wording

Tax Expenses. For the three months ended March 31, 2024, there was no change in our tax expenses as compared to the three months ended March 31, 2023.

Current wording

Tax Expenses. For the three months ended June 30, 2024, there was no material change in our tax expenses as compared to the three months ended June 30, 2023.

Previous wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $169,000 increase in Europe, a $115,000 increase in Latin America, $50,000 increase in Asia and a $10,000 increase in other geographies, for reasons mentioned in the paragraph above. This increase was offset by a $59,000 decrease in the United States as we completed in June 2023 the enrollment of all patients in our C-Guardians IDE clinical trial and accordingly there were no further enrollments in the three months ended March 31, 2024 and a $13,000 decrease in other territories.

Current wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $472,000 increase in Europe, a $28,000 increase in Latin America and a $8,000 increase in other territories for reasons mentioned above. This increase was offset by a $104,000 decrease in the United States as we completed in June 2023 the enrollment of all patients in our C-Guardians IDE clinical trial, a $30,000 decrease in Asia and a $12,000 decrease in other territories.

Previous wording

Net Loss. Our net loss increased by $2,776,000, or 65.2%, to $7,032,000, for the three months ended March 31, 2024, from $4,256,000 during the three months ended March 31, 2023. The increase in net loss resulted primarily from an increase of $2,952,000 in operating expenses and a decrease of $81,000 in gross profit, partially offset by an increase of $257,000 in financial income.

Current wording

Net Loss. Our net loss increased by $5,608,000, or 60.1%, to $14,941,000, for the six months ended June 30, 2024, from $9,333,000 during the six months ended June 30, 2023. The increase in net loss resulted primarily from an increase of $5,737,000 in operating expenses and decrease of $241,000 in gross profit, offset by an increase of $370,000 in financial income.

Previous wording

In May 2023, we closed a private placement offeringof 10,266,270 shares (the “Private Placement Shares”) of our common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by us. If the Warrants issued in the private placement offering are exercised in cash in full this would result in an additional $71.4 million of gross proceeds.

Current wording

In May 2023, we closed a private placement offering of 10,266,270 shares (the “Private Placement Shares”) of our common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by us. If the Warrants issued in the private placement offering are exercised in cash in full this would result in an additional $71.4 million of gross proceeds.

Previous wording

General. At March 31, 2024, we had cash and cash equivalents of $9,389,000 and marketable securities of $24,561,000 as compared to cash and cash equivalents of $9,640,000 and short-term bank deposits of $29,383,000 as of December 31, 2023. 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 June 30, 2024, we had cash and cash equivalents of $28,385,000 and marketable securities of $18,778,000 as compared to cash and cash equivalents of $9,640,000 and marketable securities of $29,383,000 as of December 31, 2023. 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 three months ended March 31, 2024, net cash used in our operating activities increased by $233,000, or 4.8%, to $5,064,000, from $4,831,000 during the same period in 2023. The primary reason for the increase in cash used in our operating activities was an increase of $917,000 in payments for third party related expenses and for professional services, an increase of $547,000 in compensation costs paid during the three months ended March 31, 2023, from $3,128,000 in the three months ended March 31, 2023 to $3,675,000 during the same period in 2024, offset in part by an increase of $1,185,000 in payments received from customers, and an increase of $46,000 in interest income received from money market funds and marketable securities.

Current wording

For the six months ended June 30, 2024, net cash used in our operating activities increased by $1,262,000, or 15.5%, to $9,418,000, from $8,156,000 during the same period in 2023. The primary reason for the increase in cash used in our operating activities was an increase of $1,757,000 in payments for third party related expenses and for professional services, an increase of $874,000 in compensation costs paid during the six months ended June 30, 2024, from $5,312,000 in the six months ended June 30, 2023 to $6,186,000, offset in part by an increase of $1,254,000 in payments received from customers, and an increase of $115,000 in interest income received from money market funds and marketable securities.

Previous wording

Cash provided in our investing activities was $4,817,000 during the three months ended March 31, 2024, compared to cash provided of $4,449,000 during the three months ended March 31, 2023. The primary reason for the increase in cash provided by our investing activities is a withdrawal of marketable securities of $5,040,000, net of investment in marketable securities in the three months ended March 31, 2024, compared to a withdrawal of short-term bank deposits of $4,500,000, net of investment in short-term bank deposits in the three months ended March 31, 2023, offset by an increase of $170,000 in payments made for purchase of property, plant and equipment during the three months ended March 31, 2024.

Current wording

Cash provided in our investing activities was $10,323,000 during the Six months ended June 30, 2024, compared to cash used of $22,442,000 during the Six months ended June 30, 2023. The primary reason for the increase in cash provided by our investing activities is proceeds from matured marketable securities of $11,040,000, net of investment in marketable securities in the Six months ended June 30, 2024, compared to an investment in marketable securities of $28,838,000, offset by a withdrawal from short-term bank deposits, net of investment in short-term deposits, of $6,500,000 in the Six months ended June 30, 2023 and by an increase of $600,000 in payments made for purchase of property, plant and equipment during the Six months ended June 30, 2024.

Previous wording

There was no cash provided by financing activities for the three months ended March 31, 2024 and for the three months ended March 31, 2023.

Current wording

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. Cash provided by financing activities for the six months June 30, 2023, was $37,534,000. The source of the cash provided by financing activities during the six months ended June 30, 2023, were the proceeds from the Private Placement Offering in May 2023 that resulted in approximately $37,534,000 of aggregate net proceeds.

Previous wording

As of March 31, 2024, our current assets exceeded our current liabilities by a multiple of 7.9. Current assets decreased by $5,648,000 during the period and current liabilities decreased by $1,143,000 during the period. As a result, our working capital decreased by $4,505,000 to $33,634,000 as of March 31, 2024.

Current wording

As of June 30, 2024, our current assets exceeded our current liabilities by a multiple of 7.4. Current assets increased by $7,684,000 during the period and current liabilities increased by $945,000 during the period. As a result, our working capital increased by $6,739,000 to $44,878,000 as of June 30, 2024.

Previous wording

During the three months ended March 31, 2024, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2023.

Current wording

During the six months ended June 30, 2024, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2023.