SeaStar Medical Holding Corp
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001831868-25-000007
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001437749-25-034884
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 91 previous paragraphs and 93 current paragraphs.
59 unchanged; 25 reworded; 9 added; 7 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
General and administrative expenses for the three months ended September 30, 2025 and 2024 were approximately $1.9 million and $2.2 million, respectively. The $0.3 million decrease in general and administrative expenses was the result of (i) $0.1 million decline in legal related fees, (ii) $0.3 million decline in fees due to lower franchise tax expense and a contract exit cost incurred during the quarter ended September 30, 2024 and (iii) $0.1 million decline in SEC related costs due to the Company's filing, compliance and reporting needs in 2024, offset by a (i) $0.1 million net increase in compensation costs due to the termination of our former Chief Financial Officer, and (ii) $0.1 million increase in audit fees due to the timing of interim audit activity.
Current report
Other income (net) reversed to other income of approximately $0.1 million during the three months ended September 30, 2025 compared to other expense, net of $22 thousand for the three months ended September 30, 2024, primarily due to (i) $0.1 million increase in interest income as a result of increased cash-on-hand due to financing activities, offset by (i) we recognized a favorable gain during the three months ended September 30, 2024, from the decline in fair value of its liability classified warrants, which it did not recognize during the same period ended September 30, 2025, and (ii) $0.2 million interest expense was recognized during the three months ended September 30, 2024, which we did not incur during the same period ended September 30, 2025, as we had no outstanding debt during the three months ended September 30, 2025.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Net cash used in operating activities for the nine months ended September 30, 2025 was $9.5 million compared to $11.3 million for the nine months ended September 30, 2024. The decrease in cash used for operating activities of $1.8 million is primarily due to the (i) $11.1 million decline the Company's net loss, offset by approximately $6.9 million in non-cash charges and $2.5 million favorable changes in the Company's working capital.
Removed paragraphs (7)
Previous report
General and administrative expenses for the three months ended June 30, 2025 and 2024 were approximately $1.0 million and $2.3 million, respectively. The $1.3 million decrease in general and administrative expenses was the result of (i) $0.3 million decline in audit and accounting related fees, due to the restatement of the 2023 and 2022 financials during the spring of 2024, (ii) $0.5 million decline in Directors' compensation as the active Directors approved the rescission of any earned-but-unpaid director fees as of June 30, 2025, (iii) $0.1 million in certain SEC fees as the Company brought in-house more SEC related filing activities, (iv) $0.2 million decrease in personnel costs primarily driven by the agreement by certain employees involved in general and administrative activities to rescind unpaid bonuses owed to them from 2023 and 2024, and (vi) $0.2 million in a reduction in consultant expenditures.
Previous report
Other income (net) reversed from approximately $1.4 million of net other income for the three months ended June 30, 2024, to a $0.3 million loss during the same period ended June 30, 2025. primarily due to (i) the decline in the favorable gain from the decline of the our liability classified warrants from $1.9 million for the three months ended June 30, 2024, compared to the $17 thousand decline in the three months ended June 30, 2025, offset by a (i) $0.4 million loss from the change in liability classified convertible notes during the three months ended June 30, 2024 compared to no such activity during the three months ended June 30, 2025, as no such notes existed during the three months ended June 30, 2025, (iii) $0.1 million decline in interest expense as the Company's overall debt obligations declined for the three months ended June 30, 2025, compared to the same period ended June 30, 2024, and (iv) a $0.3 million fee paid to a third party investor related to the Company's standby equity purchase agreement ("SEPA").
Previous report
our ability to receive cash proceeds from new and existing funding sources;
Previous report
the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities;
Previous report
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and
Previous report
the costs of operating as a public company, including personnel expense as well as increased director and officer insurance premiums, audit and legal fees, investor relations fees and expenses related to compliance with public company reporting requirements under the Securities Exchange Act of 1934, as amended, and rules implemented by the SEC and Nasdaq.
Previous report
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.
Reworded paragraphs (25)
Previous wording
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current wording
Item 2. Management**’s Discussion and Analysis of Financial Condition and Results of Operations.
Previous 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.
Current wording
Our senior management team has over a combined 21 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 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.
Current wording
We have incurred net losses in each year since our inception in 2007. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $148.8 million and $139.6 million, respectively. Our net losses were $9.3 million and $20.4 million for the nine months ended September 30, 2025, and 2024, respectively. For the nine months ended September 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 nine months ended September 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 June 30, 2025, and December 31, 2024, we had cash of $6.3 million and $1.8 million, respectively.
Current wording
As of September 30, 2025, and December 31, 2024, we had cash of $13.8 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 six months ended June 30, 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 nine months ended September 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 $0.8 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.
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 $0.9 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 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.
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 September 30, 2025, we have recognized approximately $0.9 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
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.
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 and obtaining financing. To the extent we 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 nine months ended September 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 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).
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, and change in the fair value of warrants liability for the three and nine months ended September 30, 2025.
Previous wording
Revenue increased $0.3 million, while gross profit also increased $0.3 million for the three months ended June 30, 2025, compared to the same period ending June 30, 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.
Current wording
Revenue increased $0.1 million, while gross profit also increased $0.1 million for the three months ended September 30, 2025, compared to the same period ending September 30, 2024. This was because we first obtained an HDE for QUELIMMUNE in February 2024, and final regulatory clearance to sell commercially from the FDA under this HDE in July 2024. We currently have nine customer sites for QUELIMMUNE* *as of September 30, 2025. We did not recognize any cost of goods sold during the three months ended September 30, 2024, as the inventory was assigned no value under US GAAP as it was expensed to research and development expense upon purchase prior to obtaining final regulatory clearance to sell QUELIMMUNE commercially.
Previous wording
Research and development expenses for the three months ended June 30, 2025 and 2024 were $1.0 million and $2.3 million, respectively. The decline in research and development expenses of approximately $1.3 million, or 56%, was primarily driven by (i) $0.7 million decline in clinical trial expenses, due to the (a) $0.3 million expense offset due to the services provided to a third-party for certain clinical research services (see Note 2), and (b) and a $0.3 million reduction in pre-clinical consulting services, (ii) $0.3 million decline in external services as a result of the Company's reducing consulting spend as it brought in-house certain assembly and regulatory services, and (iii) $0.3 million net reduction in personnel costs, primarily driven by a $0.5 million favorable reduction in bonus expense due to the agreement by certain employees involved in research and development to rescind unpaid 2023 and 2024 performance bonuses owed to them, offset by a $0.2 million increase in salaries and wage expense due to increased headcount.
Current wording
Research and development expenses for the three months ended September 30, 2025 and 2024 were $1.9 million and $2.3 million, respectively. The decline in research and development expenses of approximately $0.5 million, or 21%, was primarily driven by (i) $0.1 million decline in clinical trial expenses, due to the (a) $0.1 million expense offset due to funded research and development agreement with third-party for certain clinical research services (see Note 2), and (b) and a $0.2 million reduction in preclinical consulting services, (c) $0.1 million decline in consulting spend related to clinical trial activity, and (d) offset by $0.3 million increase in clinical trial site costs as we continue to fund its Neutralize-AKI study; (ii) $0.1 million decline in external services as a result of our reducing consulting spend as it brought in-house certain assembly and regulatory services, and (iii) $0.2 million net reduction in personnel costs, primarily driven by a $0.2 million favorable reduction in bonus expense as we are not expecting to fund bonuses for the 2025 fiscal year.
Previous 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.
Current wording
We recorded no provision for income taxes for the three months ended September 30, 2025 and September 30, 2024. respectively.
Previous 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.
Current wording
During the three months ended September 30, 2025, we had a net loss of approximately $3.5 million compared to a net loss of approximately $4.5 million for the three months ended September 30, 2024. The reason for the decreased net loss of approximately $1.0 million has been disclosed in the above discussion.
Previous wording
Comparison of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024
Current wording
Comparison of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024
Previous wording
(*) - there was no activity for the six months ended June 30, 2024.
Current wording
() - there was no activity for the nine months ended September 30, 2024.*
Previous 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.
Current wording
Revenue increased $0.7 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, as we first 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. We have nine customer sites for QUELIMMUNE* *as of September 30, 2025. We did not recognize any cost of goods sold during the three months ended September 30, 2024, as the inventory was assigned no value under US GAAP as it was expensed to research and development expense upon purchase prior to obtaining final regulatory clearance to sell QUELIMMUNE commercially.
Previous wording
Research and development expenses for the six months ended June 30, 2025 and 2024 were $3.5 million and $4.0 million, respectively. The decline in research and development expenses of approximately $0.5 million, or 13%, was primarily driven by (i) a $0.1 million net reduction in personnel costs, primarily driven by a $0.5 million favorable reduction in bonus expense due to the agreement by certain employees involved in research and development to rescind unpaid 2023 and 2024 performance bonuses owed to them, offset by a $0.4 million increase in salaries and wages due to increased headcount , (ii) $0.3 million decline in consulting services, (iii) $0.4 million decline in pre-clinical related services, and offset by (i) $0.3 million increase in clinical trial site costs as we have continued to increase the number of Neutralize-AKI sites and patients.
Current wording
Research and development expenses for the nine months ended September 30, 2025 and 2024 were $5.3 million and $6.4 million, respectively. The decline in research and development expenses of approximately $1.1 million, or 16%, was primarily driven by (i) a $0.3 million net reduction in personnel costs, primarily driven by a $0.7 million favorable reduction in bonus expense due to the agreement by certain employees involved in research and development to voluntarily forego unpaid 2023 and 2024 performance bonuses owed to them, offset by a $0.4 million increase in salaries and wages due to increased headcount , (ii) $0.2 million decline in clinical trial costs services, (iii) $0.6 million decline in external services such as non-clinical related consultant spend, and offset by (i) $0.1 million increase other research and development related costs.
Previous wording
General and administrative expenses for the six months ended June 30, 2025 and 2024 were approximately $2.7 million and $4.6 million, respectively. The $1.8 million decrease in general and administrative expenses was the result of (i) $0.2 million decline in personnel costs due to the rescission of certain employee bonuses arising from performance in 2023 and 2024, (ii) $0.1 million decline in employee conferences and seminars, (iii) $0.5 million decline in accounting related fees, due to the fact that the Company was dealing with certain restatement activities during the spring of 2024, (iv) $0.3 million decline related to legal fees, (v) $0.1 million in recruiting fees that were avoided for the six months ended June 30, 2025, (vi) $0.1 million decline in conferences and seminars, and (vi) $0.5 million decline in Directors' compensation as the active Directors approved the rescission of any earned-but-unpaid director fees as of June 30, 2025 for active Directors.
Current wording
General and administrative expenses for the nine months ended September 30, 2025 and 2024 were approximately $4.6 million and $6.8 million, respectively. The approximately $2.1 million decrease in general and administrative expenses was the result of (i) $0.1 million decline in personnel costs, net due to the voluntary foregoing of certain employee performance bonuses awarded in 2023 and 2024 that were offset by increase in compensation costs due to the termination of our former Chief Financial Officer, (ii) $0.1 million decline in employee conferences and seminars and travel, (iii) $0.4 million decline in accounting related fees, with respect to certain restatement activities during the spring of 2024, (iv) $0.4 million decline related to legal fees, (v) $0.1 million in recruiting fees that were avoided for the nine months ended September 30, 2025, (vi) $0.1 million decline in sponsorships and trade shows, and (vi) $0.5 million decline in Directors' compensation as the active Directors approved to voluntarily forego any earned-but-unpaid director fees through June 30, 2025 for active Directors, (vii) $0.2 million in consulting spend, (viii) $0.1 million reduction in insurance related expenses and (ix) $0.1 million reduction on other fees and services.
Previous 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").
Current wording
Other expenses (net) decreased approximately $7.2 million, a decline of approximately 99% for the nine months ended September 30, 2025, compared to the nine months ended September 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 nine months ended September 30, 2024, however, the Company did not have any convertible notes outstanding during the nine months ended September 30, 2025, (ii) the Company recognized a gain of $32 thousand for its liability classified warrants for the nine months ended September 30, 2025, while incurring a loss of approximately $0.8 million for the nine months ended September 30, 2024, largely driven by the value of the Company's stock and certain features of warrants that were in existence during the nine months ended September 30, 2024, that are no longer outstanding in 2025, (iii) the Company recognized interest income, net of expenses of $0.2 million during the nine months ended September 30, 2025, compared to net interest expense of $0.4 million during the nine months ended September 30, 2024. This was because the Company reduced its outstanding debt obligations such that there are no outstanding debt or notes payable obligations as of September 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") during the nine months ended September 30, 2025.
Previous wording
We recorded a provision for income taxes of $3 thousand for both the six months ended June 30, 2025, and June 30, 2024.
Current wording
We recorded a provision for income taxes of $3 thousand for both the nine months ended September 30, 2025, and September 30, 2024, respectively.
Previous wording
During the six months ended June 30, 2025, we had a net loss of approximately $5.8 million compared to a net loss of approximately $15.9 million for the six months ended June 30, 2024. The decreased net loss of approximately $10.1 million has been disclosed in the above discussion.
Current wording
During the nine months ended September 30, 2025, we had a net loss of approximately $9.2 million compared to a net loss of approximately $20.4 million for the nine months ended September 30, 2024. The decreased net loss of approximately $11.2 million has been disclosed in the above discussion.
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 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.
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 September 30, 2025 and December 31, 2024, we had stockholders' equity of approximately $11.4 million and deficit of $2.2 million, respectively, and we had an accumulated deficit of approximately $148.8 million and $139.6 million, respectively.
Previous 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.
Current wording
As of September 30, 2025, and December 31, 2024, we had cash of $13.8 million and $1.8 million, respectively. Based on our results of our operations and liquidity as of September 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 nine months ended September 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 since September 30, 2025, this additional subsequent increase in our available cash would not be sufficient to change this conclusion had that capital raise occurred prior to September 30, 2025.
Previous wording
In April 2025, the Company entered into a $15 million SEPA and unused available capacity on the ATM Facility that will allow us to potentially raise up to approximately $18.2 million (The ATM is subject baby-shelf limitations as the Company is currently limited by general instruction I.B.6 to Form S-3)
Current wording
In April 2025, the Company entered into a $15 million SEPA and as of September 30, 2025, unused available capacity on the ATM Facility that will allow us to potentially raise up to approximately $2.2 million (The ATM is subject baby-shelf limitations as the Company is currently limited by general instruction I.B.6 to Form S-3)
Previous 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.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025 was $21.5 million, was primarily related to (i) $14.3 million received from the issuance of new shares of common stock, (ii) $5.9 million in proceeds from issuance of pre-funded warrants, and (iii) $1.8 million in proceeds received from the exercise of warrants. This was offset by approximately $0.6 million paid to settle outstanding notes payable.