SeaStar Medical Holding Corp

Previous wording

Our senior management team and Board have an average of over 19 years of experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas. We also have assembled a team of well-respected scientific advisors who are experts in the development of our technology and products.

Current wording

Our senior management team has over a combined 73 years of experience in the healthcare industry, including expertise in regulatory and medical affairs, commercialization and distribution in our initial therapeutic priority areas. We also have assembled a team of well-respected scientific advisors who are experts in the development of our technology and products.

Previous wording

We have incurred net losses in each year since our inception in 2007. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $143.3 million and $139.6 million, respectively. Our net losses were $3.8 million and $12.7 million for the three months ended March 31, 2025, and 2024, respectively. For the three months ended March 31, 2025, substantially all our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. For the three months ended March 31, 2024, our net losses results from a combination of operating costs which comprised (i) research and development, and (ii) general and administrative, coupled with non-operating gains and losses due to changes in the fair value of certain liability classified financial instruments.

Current wording

We have incurred net losses in each year since our inception in 2007. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $145.3 million and $139.6 million, respectively. Our net losses were $5.8 million and $15.9 million for the six months ended June 30, 2025, and 2024, respectively. For the six months ended June 30, 2025, substantially all our net losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. For the six months ended June 30, 2024, our net losses resulted from a combination of operating costs which were comprised of (i) research and development, and (ii) general and administrative, coupled with non-operating gains and losses due to changes in the fair value of certain liability classified financial instruments.

Previous wording

As of March 31, 2025, and December 31, 2024, we had cash of $5.3 million and $1.8 million, respectively.

Current wording

As of June 30, 2025, and December 31, 2024, we had cash of $6.3 million and $1.8 million, respectively.

Previous wording

The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period from the date the unaudited condensed consolidated financial statements are made available. See Note 1 to our unaudited condensed consolidated financial statements for the three months ended March 31, 2025, included elsewhere in this Form 10-Q for additional information on our assessment.

Current wording

The recurring losses, working capital deficiency, the need for capital to fund our operations, including clinical trial and regulatory approval expenses, and the amount of cash reserve are factors that raise substantial doubt about our ability to continue as a going concern for the twelve-month period from the date the unaudited condensed consolidated financial statements are made available. See Note 1 to our unaudited condensed consolidated financial statements for the six months ended June 30, 2025, included elsewhere in this Form 10-Q for additional information on our assessment.

Previous wording

Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have generated revenue of approximately $0.5 million from the sale of commercialized pediatric SCD products. Our ability to generate product revenue in the future will depend on the successful roll-out of our QUELIMMUNE pediatric SCD to hospitals and the development and eventual successful commercialization of our adult SCD. Until such time we are able to generate significant revenue from product sales, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs and any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See Part I, Item 1A“Risk Factors” for additional information.

Current wording

Our need for additional capital will depend in part on the scope and costs of our development activities. To date, we have generated revenue of approximately $0.8 million from the sale of commercialized pediatric SCD products. Our ability to generate product revenue in the future will depend on the successful roll-out of our QUELIMMUNE pediatric SCD to hospitals and the development and eventual successful commercialization of our adult SCD. Until such time we are able to generate significant revenue from product sales, we expect to finance our operations through the sale of equity or debt, borrowings under credit facilities, potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms. If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs and any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See Part I, Item 1A“Risk Factors” for additional information.

Previous wording

Our QUELIMMUNE received HDE approval from the FDA in February 2024. Since that time, we have begun to build out our commercial operations, develop our customer base and initiate commercial sales of QUELIMMUNE. We shipped our first commercial QUELIMMUNE units in July 2024. Through March 31, 2025, we have recognized approximately $0.4 million of revenue from the sale of QUELIMMUNE. Historically, prior period revenue has been primarily derived from government and other grants. We will continue to focus our efforts on generating revenue in the future based on product sales of QUELIMMUNE, as well as potential future payments from license or collaboration agreements and government and other grants.

Current wording

Our QUELIMMUNE received HDE approval from the FDA in February 2024. Since that time, we have begun to build out our commercial operations, develop our customer base and initiate commercial sales of QUELIMMUNE. We shipped our first commercial QUELIMMUNE units in July 2024. Through June 30, 2025, we have recognized approximately $0.8 million of revenue from the sale of QUELIMMUNE. Historically, prior period revenue has been primarily derived from government and other grants. We will continue to focus our efforts on generating revenue in the future based on product sales of QUELIMMUNE, as well as potential future payments from license or collaboration agreements and government and other grants.

Previous wording

We expect that any revenue we generate will fluctuate from quarter to quarter as we introduce QUELIMMUNE to pediatric hospital customers. We also continue to develop our adult SCD for which we are enrolling patients in a pivotal trial to support a FDA approval. If we fail to complete the development of, or fail to obtain regulatory approval for commercialization of our adult SCD in a timely manner, our ability to generate future revenue, and our results of operations and financial position, could be materially adversely affected.

Current wording

We expect that any revenue we generate will fluctuate from quarter to quarter as we introduce QUELIMMUNE to pediatric hospital customers. We also continue to develop our adult SCD for which we are enrolling patients in a pivotal clinical trial to support FDA approval. If we fail to complete the development of or fail to obtain regulatory approval to commercialize our adult SCD in a timely manner, our ability to generate future revenue, and our results of operations and financial position, could be materially adversely affected.

Previous wording

Other significant general and administrative expenses include facilities costs, insurance, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents obtaining financing. As we continue to expand and grow our operations, we expect that our general and administrative expenses will increase, including additional expenses relating to new hires, travel, an enterprise resource planning platform, and branding.

Current wording

Other significant general and administrative expenses include facilities costs, insurance, professional fees for accounting and legal services and expenses associated with obtaining and maintaining patents obtaining financing. As we continue to expand and grow our operations, we expect that our general and administrative expenses will increase, including additional expenses relating to new hires, travel, an enterprise resource planning platform, and branding. However, the Company is also in the process, as evidenced by the results of the three and six months ended June 30, 2025, of reducing overall general and administrative spend, and identifying efficiencies.

Previous wording

Total other income (expense), net primarily consists of interest expense relating to interest incurred on our notes, interest incurred on our convertible notes, change in the fair value of warrants liability, change in fair value of convertible notes, gain on issuance of convertible notes, change in fair value of forward-option forward contracts, and gain on sale of recycled shares.

Current wording

Total other income (expense), net primarily consists of interest expense relating to interest incurred on our notes, interest income due to overnight sweep activity with the Company's main commercial financial institution, change in the fair value of warrants liability, and change in fair value of convertible notes (six and three months ended June 30, 2024 only).

Previous wording

We recorded a provision for income taxes of $3 thousand for the three months ended March 31, 2025, and no provision for income taxes for the three months ended March 31, 2024.

Current wording

We recorded no provision for income taxes for the three months ended June 30, 2025, and $3 thousand provision for income taxes for the three months ended June 30, 2024.

Previous wording

During the three months ended March 31, 2025, we had a net loss of approximately $3.8 million compared to a net loss of approximately $12.7 million for the three months ended March 31, 2024. The decreased net loss of approximately $8.9 million has been disclosed in the above discussion.

Current wording

During the three months ended June 30, 2025, we had a net loss of approximately $2.0 million compared to a net loss of approximately $3.2 million for the three months ended June 30, 2024. The decreased net loss of approximately $1.2 million has been disclosed in the above discussion.

Previous wording

Revenue increased $0.3 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024, as we commenced commercial sales in July 2024. This was made possible because we obtained an HDE for QUELIMMUNE in February 2024, and final regulatory clearance to sell commercially from the FDA under this HDE in July 2024. The Company has five customer sites for QUELIMMUNE as of March 31, 2025.

Current wording

Revenue increased $0.6 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024, as we commenced commercial sales in July 2024. This was made possible because we obtained an HDE for QUELIMMUNE in February 2024, and final regulatory clearance to sell commercially from the FDA under this HDE in July 2024. The Company has six customer sites for QUELIMMUNE as of June 30, 2025.

Previous wording

Other expenses (net) decreased approximately $8.8 million, or near a decline of 100% for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The key drivers for this decrease were as follows: (i) the Company recognized a loss of $5.8 million for changes in the fair value of convertible notes during the three months ended March 31, 2024, however, the Company did not have any convertible notes outstanding during the three months ended March 31, 2025, (ii) the Company recognized a gain of $16 thousand for its liability classified warrants for the three months ended March 31, 2024, while incurring a loss of approximately $2.8 million for the three months ended March 31, 2023, largely driven by the value of the Company's stock, (iii) the Company recognized interest income, net of expenses of $37 thousand, compared to interest expense of $143 thousand during the three months ended March 31, 2024. This was because the Company reduced its outstanding debt obligations from approximately $4.2 million at March 31, 2024, to $0.4 million as of March 31, 2025, and implemented an overnight sweep program with its main commercial banking financial institution beginning in the second quarter of 2024.

Current wording

Other expenses (net) decreased approximately $7.1 million, a decline of approximately 97% for the six months ended June 30, 2025, compared to the six months ended June 30, 2024. The key drivers for this decrease were as follows: (i) the Company recognized a loss of $6.1 million for changes in the fair value of convertible notes during the six months ended June 30, 2024, however, the Company did not have any convertible notes outstanding during the six months ended June 30, 2025, (ii) the Company recognized a gain of $33 thousand for its liability classified warrants for the six months ended June 30, 2025, while incurring a loss of approximately $1.0 million for the six months ended June 30, 2024, largely driven by the value of the Company's stock and certain features of warrants that were in existence during the six months ended June 30, 2024, that are no longer outstanding in 2025, (iii) the Company recognized interest income, net of expenses of $74 thousand during the six months ended June 30, 2024, compared to net interest expense of $200 thousand during the six months ended June 30, 2025. This was because the Company reduced its outstanding debt obligations from approximately $3.1 million as of June 30, 2024, to no outstanding debt or notes payable obligations as of June 30, 2025. This was offset by a $0.3 million fee paid to a third-party investor related to the Company's standby equity purchase agreement ("SEPA").

Previous wording

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, 2025 and December 31, 2024, we had an accumulated deficit of approximately $143.3 million and $139.6 million, respectively.

Current wording

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 June 30, 2025 and December 31, 2024, we had shareholders equity of approximately $3.3 million and we had an accumulated deficit of approximately $145.3 million and $139.6 million, respectively.

Previous wording

As of March 31, 2025 and December 31, 2024, we had cash of $5.3 million and $1.8 million, respectively. Based on our results of operations and liquidity as of March 31, 2025, we believe our cash and cash equivalents, including the cash we obtained from the registered direct financing in the first quarter of 2025 and the registered direct offering in July 2024, are not sufficient to meet our working capital and capital expenditure requirements for a period of at least twelve months from the date of our unaudited condensed consolidated financial statements for the three months ended March 31, 2025, are made available. We believe that this raises substantial doubt about our ability to continue as a going concern.

Current wording

As of June 30, 2025, and December 31, 2024, we had cash of $6.3 million and $1.8 million, respectively. Based on our results of our operations and liquidity as of June 30, 2025, and even when taking into account (i) a public offering in the second quarter of 2025, (ii) a registered direct offering in the first quarter of 2025, and (iii) access to raise money on an at-the-market facility ("ATM Facility") and standby equity purchase agreement ("SEPA"), we believe our cash and cash equivalents are insufficient to meet our working capital and capital expenditure requirements for a period of at least twelve months from the date of our unaudited condensed consolidated financial statements for the six months ended June 30, 2025, are made available. We believe that this raises substantial doubt about our ability to continue as a going concern. While the Company raised additional capital in July of 2025, this additional subsequent increase in our available cash would not be sufficient to change this conclusion had that capital raise occurred prior to June 30, 2025.

Previous wording

To finance our operations, we will need to raise additional capital. As described below, we do not expect to receive any cash proceeds from the exercise of warrants in the near term, because the trading price of our common stock is currently below the exercise price of such warrants. We are seeking additional cash to fund our growth through future debt or equity financing transactions; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, if at all, or that we will generate sufficient future revenues and cash flows to fund our operations. We do not currently have any committed external source of funds. We have concluded that these circumstances raise doubt about our ability to continue as a going concern within one year after the issuance date of this Form 10-Q. See Note 1 to our unaudited condensed consolidated financial statements for the period ended March 31, 2025.

Current wording

To finance our operations, we will need to raise additional capital. As described below, we cannot expect to receive any cash proceeds from the exercise of warrants in the near term, because the exercise of warrants is not in our control. We are seeking additional cash to fund our growth through future debt or equity financing transactions; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, if at all, or that we will generate sufficient future revenues and cash flows to fund our operations. We do not currently have any committed external source of funds. We have concluded that these circumstances raise doubt about our ability to continue as a going concern within one year after the issuance date of this Form 10-Q. See Note 1 to our unaudited condensed consolidated financial statements for the period ended June 30, 2025.

Previous wording

We would receive the proceeds from any exercise of warrants that are exercised for cash pursuant to their terms. To the extent any warrants are exercised on a“cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease. We would expect to use any such proceeds received from warrants that are exercised for cash in the future for general corporate and working capital purposes, which would increase our liquidity. However, we will only receive such proceeds if and when the warrant holders exercise the warrants. The exercise of the warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our common stock and the spread between the exercise price of the warrant and the price of our common stock at the time of exercise. There is no assurance that the warrant holders will elect to exercise for cash any or all of such warrants, and we believe that any such exercise currently is unlikely to occur. The likelihood that warrant holders will exercise the warrants, and therefore the amount of cash proceeds that we would receive from such exercise, is dependent upon the trading price of our common stock. If the trading price for our common stock remains less than the respective exercise price of our outstanding warrants, we believe our warrant holders will be unlikely to exercise their warrants. There is no guarantee that the warrants will be in the money following the time they become exercisable and prior to their expiration, and as such, the warrants may expire worthless, and we may not receive any proceeds from the exercise of the warrants. To the extent that any of the warrants are exercised on a“cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease.

Current wording

If exercised, we could receive the proceeds from any exercise of warrants that are exercised for cash pursuant to their terms. To the extent any warrants are exercised on a“cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease. We would expect to use any such proceeds received from warrants that are exercised for cash in the future for general corporate and working capital purposes, which would increase our liquidity. However, we will only receive such proceeds if and when the warrant holders exercise the warrants. The exercise of the warrants, and any proceeds we may receive from their exercise, are highly dependent on the price of our common stock and the spread between the exercise price of the warrant and the price of our common stock at the time of exercise. There is no assurance that the warrant holders will elect to exercise for cash any or all of such warrants, and we believe that any such exercise currently is unlikely to occur. The likelihood that warrant holders will exercise the warrants, and therefore the amount of cash proceeds that we would receive from such exercise, is dependent upon the trading price of our common stock. If the trading price for our common stock remains less than the respective exercise price of our outstanding warrants, we believe our warrant holders will be unlikely to exercise their warrants. There is no guarantee that the warrants will be in the money following the time they become exercisable and prior to their expiration, and as such, the warrants may expire worthless, and we may not receive any proceeds from the exercise of the warrants. To the extent that any of the warrants are exercised on a“cashless basis,” the amount of cash we would receive from the exercise of the warrants will decrease.

Previous wording

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our adult SCD for approval by the FDA, invest in our commercialization of our pediatric SCD, and (ii) if regulatory approval is obtained, to launch and commercialize our adult SCD in the U.S. market, including potential subsequent launches in key international markets. We will need additional funding in connection with these activities. Our future funding requirements, both short-term and long-term, will depend on many factors, including:

Current wording

We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue clinical development of our adult SCD for approval by the FDA, invest in commercialization of QUELIMMUNE and continue to develop the next generation SCDs and (ii) if regulatory approval is obtained, to launch and commercialize our adult SCD in the U.S. market, including potential subsequent launches in key international markets. We will need additional funding in connection with these activities. Our future funding requirements, both short-term and long-term, will depend on many factors, including:

Previous wording

Net cash used in operating activities for the three months ended March 31, 2025 was $2.7 million compared to $3.5 million for the three months ended March 31, 2024. The decrease in cash used for operating activities of $0.8 million is primarily due to the $0.8 million due to the timing of certain (i) payments from customers or to vendors to reduce our cash outflows for operating activities.

Current wording

Net cash used in operating activities for the six months ended June 30, 2025 was $5.7 million compared to $6.3 million for the six months ended June 30, 2024. The decrease in cash used for operating activities of $0.6 million is primarily due to the $0.6 million due to (i) the timing of certain payments from customers or to vendors to reduce our cash outflows for operating activities and (ii) the Company's reduced operating expenditures during the six months ended June 30, 2025 compared to the same period ended June 30, 2024.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2025 was $6.1 million, was primarily related to (i) $1.6 million received from the issuance of new shares of common stock, and (ii) $4.8 million in proceeds from issuance of pre-funded warrants. This was offset by (i) $0.2 million paid to settle outstanding notes payable.

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $10.1 million, was primarily related to (i) $5.2 million received from the issuance of new shares of common stock, and (ii) $5.6 million in proceeds from issuance of pre-funded warrants. This was offset by approximately $0.6 million paid to settle outstanding notes payable.