Research and Development Expenses
The following table discloses the breakdown of research and development expenses:
| | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, | | | Change | |
($ in thousands) | | 2023 | | | 2022 | | | $ | | | % | |
Clinical trials | | $ | 550 | | | $ | — | | | $ | 550 | | | | 100 | % |
External services | | | 603 | | | | 270 | | | | 333 | | | | 123 | % |
Payroll and personnel expenses | | | 568 | | | | 43 | | | | 525 | | | | 1,221 | % |
Other research and development expenses | | | 63 | | | | 42 | | | | 21 | | | | 50 | % |
| | | | | | | | | | | | | | | | |
| | $ | 1,784 | | | $ | 355 | | | $ | 1,429 | | | | 403 | % |
| | | | | | | | | | | | | | | | |
Research and development expenses for the three months ended March 31, 2023 and 2022 were $1.8 million and $0.4 million, respectively. The increase in research and development expenses of $1.4 million, or 403%, was primarily driven by increases in clinical trial expenses of $0.6 million, an increase in the use of external services of $0.3 million, and an increase in payroll and personnel expenses of $0.5 million.
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2023 and 2022 were $2.8 million and $0.5 million, respectively. The increase in general and administrative expenses of $2.3 million, or 512%, was driven by an increase in professional fees related to SEC reporting of $0.6 million, an increase in payroll related expenses of $0.7 million, an increase in insurance expense of $0.4 million, expenses related to financial instruments of $0.1 million, cost of SEC reporting of $0.2 million, a legal settlement of $0.2, and an increase in marketing expenses of $0.1 million.
Other Income (Expense)
Other income (expense) for the three months ended March 31, 2023 and 2022 was expense of $0.7 million and expense of $0.2 million, respectively. The increase of $0.5 million primarily resulted from the change in fair value of forward option-prepaid forward contracts, partially offset by the change in fair value of convertible notes, gain in the issuance of convertible notes, and a gain on sales of recycled shares.
Income Tax Provision (Benefit)
SeaStar Medical recorded a provision for income taxes of $0.0 million for the three months ended March 31, 2023, and an income tax benefit of $0.0 million for the three months ended March 31, 2022.
Under Accounting Standards Codification (“ASC”) 740-10-30-5, Income Taxes, deferred tax assets should be reduced by a valuation allowance if, based on the weight of available evidence, it is more-likely-than-not (i.e., a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. SeaStar Medical considers all positive and negative evidence available in determining the potential realization of deferred tax assets including, primarily, the recent history of taxable earnings or losses. Based on operating losses reported during 2022 and 2021, the Company concluded there was not sufficient positive evidence to overcome this recent operating history. As a result, we believe that a valuation allowance continues to be necessary based on the more-likely-than-not threshold noted above.
Net Loss
During the three months ended March 31, 2023, SeaStar Medical had a net loss of $5.3 million compared to a net loss of $1.0 million for the three months ended March 31, 2022. The increased net loss of $4.3 million primarily resulted from increases in general and administrative expenses of $2.3 million, increases in research and development expenses of $1.4 million, change in fair value of forward option-prepaid forward contracts of $1.7 million, partially offset by the change in fair value of convertible notes of $0.1 million and a gain on sale of recycled shares of $1.3 million during the three months ended March 31, 2023.
Comparison of Year Ended December 31, 2022 to Year Ended December 31, 2021
The following table sets forth a summary of our results of operations. This information should be read together with our consolidated financial statements and related Notes included elsewhere in this prospectus.
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| | Year Ended | | | | | | | |
| | December 31, | | | Change | |
($ in thousands) | | 2022 | | | 2021 | | | $ | | | % | |
Revenue | | $ | — | | | $ | — | | | $ | — | | | | — | |
Operating expenses | | | | | | | | | | | | | | | | |
Research and development | | | 2,819 | | | | 2,766 | | | | 53 | | | | 2 | % |
General and administrative | | | 6,600 | | | | 1,683 | | | | 4,917 | | | | 292 | % |
Origination cost of forward contracts | | | 2,190 | | | | — | | | | 2,190 | | | | | |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 11,609 | | | | 4,449 | | | | 7,160 | | | | 161 | % |
| | | | | | | | | | | | | | | | |
Loss from operations | | | (11,609 | ) | | | (4,449 | ) | | | (7,160 | ) | | | 161 | % |
| | | | | | | | | | | | | | | | |
Total other income (expense) | | | (11,403 | ) | | | (148 | ) | | | (11,255 | ) | | | 7605 | % |
| | | | | | | | | | | | | | | | |
Loss before income tax provision | | | (23,012 | ) | | | (4,597 | ) | | | (18,415 | ) | | | 401 | % |
| | | | | | | | | | | | | | | | |
Income tax provision (benefit) | | | 1 | | | | (1 | ) | | | 2 | | | | | |
| | | | | | | | | | | | | | | | |
Net loss | | $ | (23,013 | ) | | $ | (4,596 | ) | | $ | (18,417 | ) | | | 401 | % |
| | | | | | | | | | | | | | | | |
Research and Development Expenses
The following table discloses the breakdown of research and development expenses:
| | | | | | | | | | | | | | | | |
| | Year Ended | | | | | | | |
| | December 31, | | | Change | |
($ in thousands) | | 2022 | | | 2021 | | | $ | | | % | |
Clinical trials | | $ | — | | | $ | 989 | | | $ | (989 | ) | | | (100 | )% |
External services | | | 1,997 | | | | 1,278 | | | | 719 | | | | 56 | % |
Payroll and personnel expenses | | | 658 | | | | 353 | | | | 305 | | | | 86 | % |
Other research and development expenses | | | 164 | | | | 146 | | | | 18 | | | | 12 | % |
| | | | | | | | | | | | | | | | |
| | $ | 2,819 | | | $ | 2,766 | | | $ | 53 | | | | 2 | % |
| | | | | | | | | | | | | | | | |
General and Administrative Expenses
General and administrative expenses for the years ended December 31, 2022 and 2021 were $6.6 million and $1.7 million, respectively. The increase in general and administrative expenses of $4.9 million, or 292%, was driven by an increase in payroll expense of $1.9 million, commitment fees for equity line of credit of $2.5 million, an increase in legal fees of $0.2 million, and an increase in insurance of $0.3 million.
Other Income (Expense)
Other income (expense) for the years ended December 31, 2022 and 2021 was expense of $11.4 million and expense of $0.2 million, respectively. The increase of $11.2 million primarily resulted from a loss in change in fair value of forward option of $10.2 million, a loss in change in fair value of convertible notes derivative liability of $0.6 million, and an increase in interest expense of $0.4 million.
Income Tax Provision (Benefit)
SeaStar Medical recorded a provision for income taxes of $0.0 million for the year ended December 31, 2022, and an income tax benefit of $0.0 million for the year ended December 31, 2021.
Under Accounting Standards Codification (“ASC”) 740-10-30-5, Income Taxes, deferred tax assets should be reduced by a valuation allowance if, based on the weight of available evidence, it is more-likely-than-not (i.e., a likelihood of more than 50%) that some portion or all of the deferred tax assets will not be realized. SeaStar Medical considers all positive and negative evidence available in determining the potential realization of deferred tax assets including, primarily, the recent history of taxable earnings or losses. Based on operating losses reported during 2022 and 2021, the Company concluded there was not sufficient positive evidence to overcome this recent operating history. As a result, we believe that a valuation allowance continues to be necessary based on the more-likely-than-not threshold noted above. A valuation allowance of $23.8 million and $18.2 million was recorded for the years ended December 31, 2022 and 2021, respectively.
Net Loss
During the year ended December 31, 2022, SeaStar Medical had a net loss of $23.0 million compared to a net loss of $4.6 million for the year ended December 31, 2021. The increased net loss of $18.4 million primarily resulted from increases in general and administrative expenses of $4.9 million, increases in research and development expenses of $0.1 million, origination cost of forward contracts of $2.2 million, and increases in other expense of $11.2 million during the year ended December 31, 2022.
Liquidity and Capital Resources
Sources of Liquidity
To date, we have financed our operations primarily through the sale of equity securities and convertible debt and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows. As of March 31, 2023, we had an accumulated deficit of $104.6 million. As of December 31, 2022 and December 31, 2021, we had an accumulated deficit of $99.3 million and $76.3 million, respectively.
As of March 31, 2023, we had cash of $0.7 million. As of December 31, 2022 and December 31, 2021, we had cash of $0.0 million and $0.5 million, respectively. We expect that our existing cash will be insufficient to fund our operations, including clinical trial expenses and capital expenditure requirements. We believe that
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