Financial Performance - Net losses for the years ended December 31, 2024, and 2023 were $24.8 million and $26.2 million, respectively, with a decrease of 5.3% in net loss year-over-year [362][378]. - The net loss decreased to $24.8 million in 2024 from $26.2 million in 2023, attributed to a $5.0 million reduction in other expenses [388]. - The company had an accumulated deficit of approximately $139.6 million as of December 31, 2024 [362]. - As of December 31, 2024, the accumulated deficit reached $139.6 million, up from $114.7 million in 2023 [390]. - Other income (expense) improved to an expense of $7.0 million in 2024 from $12.0 million in 2023, mainly due to a $4.2 million decline in losses from convertible notes [384]. Revenue and Sales - The pediatric SCD, QUELIMMUNE, received FDA approval on February 21, 2024, and the first commercial units were shipped in July 2024, generating approximately $0.1 million in revenue by December 31, 2024 [368][380]. - The company expects revenue to fluctuate as QUELIMMUNE is introduced to pediatric hospital customers and is focused on generating future revenue from product sales and potential collaborations [368][369]. Expenses - Research and development expenses increased by $3.1 million, or 52.4%, from $6.0 million in 2023 to $9.1 million in 2024, primarily due to clinical trial costs and increased personnel expenses [370][381]. - Total operating expenses rose by $3.8 million, or 26.5%, from $14.2 million in 2023 to $18.0 million in 2024 [378]. - General and administrative expenses increased by 7.7% to $8.9 million in 2024 from $8.2 million in 2023, primarily due to increased payroll and accounting costs [383]. Cash Flow and Financing - Cash and cash equivalents were approximately $1.8 million as of December 31, 2024, compared to $0.2 million in 2023 [363]. - Cash used in operating activities rose to $16.0 million in 2024 from $10.3 million in 2023, driven by increased clinical trial activities [393]. - Cash provided by financing activities increased to $17.7 million in 2024 from $10.4 million in 2023, primarily from the issuance of new shares and convertible notes [394]. - The company raised approximately $23.5 million through registered direct offerings and "At-the-Market" offerings since the effectiveness of its shelf registration on December 22, 2023 [396]. - The company had cash of $1.8 million as of December 31, 2024, compared to $0.2 million in 2023, indicating a need for additional funding [391]. Clinical Trials - The pivotal clinical trial for the adult SCD is currently underway with 94 patients enrolled as of March 25, 2025 [355]. - The increase in clinical trial expenses was driven by the Neutralize-AKI Adult SCD study, which had 14 clinical trial sites enrolled by the end of 2024 [381]. Future Outlook and Concerns - The company has incurred net losses since its inception in 2007, raising concerns about its ability to continue as a going concern [364][365]. - Future funding requirements will depend on the progress of clinical trials and the ability to secure additional capital, with no committed external sources currently available [400]. Regulatory and Compliance - The company is classified as an emerging growth company (EGC) under the JOBS Act, allowing it to delay compliance with new accounting standards until it no longer qualifies as an EGC or opts out of the transition period [413]. - The company will remain an EGC until it has total annual gross revenue of at least $1.235 billion or meets other specified criteria [415]. - The company is not required to provide an auditor's attestation report on internal controls due to its EGC status [414]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [419]. Obligations and Arrangements - The company has total contractual obligations of $574,000, all of which are due within one year [417]. - In October 2024, the company entered into a financing arrangement for an insurance policy premium amounting to $0.7 million, to be paid in 10 monthly installments through August 2025 [418]. - The company entered into various convertible credit agreements with an institutional investor, which included detachable warrants [416]. - The company assumed 229,520 Private Placement warrants as part of the Business Combination [416].
SeaStar Medical(ICU) - 2024 Q4 - Annual Report