[10-Q] SeaStar Medical Holding Corporation Quarterly Earnings Report
SeaStar Medical Holding Corporation (ICU) reported early commercial sales of its pediatric SCD product QUELIMMUNE, recognizing $338 thousand in revenue for the quarter and $631 thousand for the six months ended June 30, 2025. Gross profit was $311 thousand for the quarter and $604 thousand for six months; cost of goods sold was $27 thousand. The company recorded a net loss of $2.0 million for the quarter and $5.8 million for the six months, with a weighted-average share base of 11.33 million and basic and diluted net loss per share of $(0.18) and $(0.58), respectively.
The balance sheet shows $6.3 million in cash and $8.4 million in total assets as of June 30, 2025, and an accumulated deficit of $145.3 million. Management states it does not believe existing cash is sufficient to fund operations for 12 months and discloses substantial doubt about going concern. The filing details multiple 2025 equity financings (February, June, ATM proceeds) and subsequent July/August 2025 registered offerings, and notes receipt of a Nasdaq notice for bid-price noncompliance with a cure period to January 27, 2026.
SeaStar Medical Holding Corporation (ICU) ha registrato le prime vendite commerciali del suo prodotto pediatrico per SCD, QUELIMMUNE, riconoscendo ricavi per $338 mila nel trimestre e $631 mila nei sei mesi chiusi il 30 giugno 2025. Il margine lordo 猫 stato di $311 mila nel trimestre e $604 mila nei sei mesi; il costo del venduto 猫 stato di $27 mila. La societ脿 ha riportato una perdita netta di $2,0 milioni nel trimestre e $5,8 milioni nei sei mesi, con una base media ponderata di azioni di 11,33 milioni e una perdita per azione base e diluita rispettivamente di $(0,18) e $(0,58).
Lo stato patrimoniale mostra $6,3 milioni in liquidit脿 e $8,4 milioni di attivit脿 totali al 30 giugno 2025, con un disavanzo accumulato di $145,3 milioni. La direzione afferma di non ritenere che la disponibilit脿 liquida attuale sia sufficiente a finanziare le operazioni per 12 mesi e indica notevoli dubbi sulla continuit脿 aziendale. Il documento descrive diversi aumenti di capitale nel 2025 (febbraio, giugno, proventi ATM) e offerte registrate successive a luglio/agosto 2025, e segnala il ricevimento di un avviso Nasdaq per non conformit脿 al prezzo minimo delle azioni, con un periodo di rimedio fino al 27 gennaio 2026.
SeaStar Medical Holding Corporation (ICU) inform贸 ventas comerciales iniciales de su producto pedi谩trico para SCD, QUELIMMUNE, reconociendo $338 mil en ingresos en el trimestre y $631 mil en los seis meses terminados el 30 de junio de 2025. El beneficio bruto fue de $311 mil en el trimestre y $604 mil en seis meses; el costo de los bienes vendidos fue de $27 mil. La compa帽铆a registr贸 una p茅rdida neta de $2,0 millones en el trimestre y $5,8 millones en los seis meses, con una base media ponderada de acciones de 11,33 millones y una p茅rdida por acci贸n b谩sica y diluida de $(0,18) y $(0,58), respectivamente.
El balance muestra $6,3 millones en efectivo y $8,4 millones en activos totales al 30 de junio de 2025, y un d茅ficit acumulado de $145,3 millones. La direcci贸n declara que no considera que el efectivo disponible sea suficiente para financiar las operaciones durante 12 meses y revela dudas sustanciales sobre la continuidad operativa. El informe detalla varias financiaciones de capital en 2025 (febrero, junio, ingresos ATM) y ofertas registradas posteriores en julio/agosto de 2025, y se帽ala la recepci贸n de un aviso de Nasdaq por incumplimiento del precio de oferta, con un periodo para subsanar hasta el 27 de enero de 2026.
SeaStar Medical Holding Corporation (ICU)電� 靻岇晞 SCD 鞝滍拡 QUELIMMUNE鞚� 齑堦赴 靸侅梾 韺愲Г毳� 氤搓碃頃橂┌ 攵勱赴 毵れ稖 $338觳�, 2025雲� 6鞗� 30鞚茧 雭濍倶電� 6臧滌洈 霃欖晥 $631觳滌潣 毵れ稖鞚� 鞚胳嫕頄堨姷雼堧嫟. 齑濎澊鞚奠潃 攵勱赴 $311觳�, 6臧滌洈 $604觳滌澊鞐堦碃 毵れ稖鞗愱皜電� $27觳滌澊鞐堨姷雼堧嫟. 須岇偓電� 攵勱赴 靾滌啇鞁� $2.0氚彪, 6臧滌洈 靾滌啇鞁� $5.8氚彪鞚� 旮半頄堨溂氅�, 臧�欷戫弶攴� 欤检嫕靾橂姅 11.33氚彪欤�, 旮半掣 氚� 頋劃 旮办 欤茧嫻靾滌啇鞁れ潃 臧侁皝 $(0.18) 氚� $(0.58)鞓�鞀惦媹雼�.
雽�彀寑臁绊憸靸� 2025雲� 6鞗� 30鞚� 旮办 順勱笀 $6.3氚彪, 齑濎瀽靷� $8.4氚彪鞚措┌ 雸勳爜鞝侅瀽電� $145.3氚彪鞛呺媹雼�. 瓴届榿歆勳潃 順� 鞙犽彊靹膘澊 12臧滌洈臧� 鞓侅梾鞚� 鞙犾頃橁赴鞐� 於╇秳頃橃 鞎婋嫟瓿� 韺愲嫧頃橂┌ 瓿勳啀旮办梾 臁挫啀鞐� 雽�頃� 靸侂嫻頃� 鞚橂鞚� 瓿店皽頄堨姷雼堧嫟. 鞝滌稖靹滊電� 2025雲勳潣 鞐煬 欤检嫕 鞛愱笀 臁半嫭(2鞗�, 6鞗�, ATM 靾橃澋)瓿� 2025雲� 7路8鞗旍潣 霌彪 瓿惦毳� 靸侅劯頌� 靹る獏頃橁碃 鞛堨溂氅�, 順戈皜 臧�瓴� 氙鸽嫭搿� 鞚疙暅 雮橃姢雼� 韱奠 靾橂牴 氚� 2026雲� 1鞗� 27鞚缄箤歆�鞚� 鞁滌爼 旮瓣皠鞚� 旮办灛頃橁碃 鞛堨姷雼堧嫟.
SeaStar Medical Holding Corporation (ICU) a d茅clar茅 les premi猫res ventes commerciales de son produit p茅diatrique pour SCD, QUELIMMUNE, enregistrant 338 000 $ de revenus pour le trimestre et 631 000 $ pour les six mois clos le 30 juin 2025. La marge brute s'est 茅lev茅e 脿 311 000 $ pour le trimestre et 604 000 $ pour les six mois ; le co没t des ventes 茅tait de 27 000 $. La soci茅t茅 a enregistr茅 une perte nette de 2,0 M$ pour le trimestre et de 5,8 M$ pour les six mois, avec une base moyenne pond茅r茅e d'actions de 11,33 millions et une perte par action de base et dilu茅e de (0,18 $) et (0,58 $), respectivement.
Le bilan indique 6,3 M$ de tr茅sorerie et 8,4 M$ d'actifs totaux au 30 juin 2025, et un d茅ficit cumul茅 de 145,3 M$. La direction indique qu'elle ne consid猫re pas la tr茅sorerie actuelle suffisante pour financer les op茅rations pendant 12 mois et r茅v猫le doutes importants sur la continuit茅 d'exploitation. Le d茅p么t d茅taille plusieurs financements en actions en 2025 (f茅vrier, juin, produits ATM) et des offres enregistr茅es ult茅rieures en juillet/ao没t 2025, et signale la r茅ception d'un avis du Nasdaq pour non-conformit茅 au prix d'appel, avec une p茅riode de r茅paration jusqu'au 27 janvier 2026.
SeaStar Medical Holding Corporation (ICU) meldete fr眉hzeitige kommerzielle Verk盲ufe ihres p盲diatrischen SCD-Produkts QUELIMMUNE und verbuchte im Quartal Einnahmen von $338.000 und $631.000 f眉r die sechs Monate zum 30. Juni 2025. Der Bruttogewinn lag bei $311.000 im Quartal und $604.000 f眉r sechs Monate; die Herstellungskosten betrugen $27.000. Das Unternehmen verzeichnete einen Nettoverlust von $2,0 Mio. im Quartal und $5,8 Mio. f眉r sechs Monate, mit einer gewichteten durchschnittlichen Aktienbasis von 11,33 Mio. und einem unverw盲sserten sowie verw盲sserten Ergebnis je Aktie von $(0,18) bzw. $(0,58).
Die Bilanz weist zum 30. Juni 2025 $6,3 Mio. in Barbest盲nden und $8,4 Mio. an Gesamtverm枚gen sowie ein kumuliertes Defizit von $145,3 Mio. aus. Das Management geht davon aus, dass die vorhandenen Mittel nicht ausreichen, um den Betrieb f眉r 12 Monate zu finanzieren, und offenbart erhebliche Zweifel an der Fortf眉hrungsf盲higkeit. Die Einreichung erl盲utert mehrere Eigenkapitalfinanzierungen 2025 (Februar, Juni, ATM-Erl枚se) und nachfolgende registrierte Angebote im Juli/August 2025 und vermerkt den Erhalt einer Nasdaq-Mitteilung wegen Nichteinhaltung des Mindestgebotspreises mit einer Nachfrist bis zum 27. Januar 2026.
- None.
- None.
Insights
TL;DR Early commercial revenue and multiple financings improved liquidity, but operating losses and going-concern doubts remain material.
The company has transitioned to limited commercial sales of QUELIMMUNE, producing $631k year-to-date revenue and positive gross margin on those sales. Multiple capital raises in 2025 (February and June offerings, ATM proceeds) increased cash to $6.3M at June 30, 2025, which temporarily improves runway. However, recurring operating losses ($5.8M six months) and an accumulated deficit of $145.3M mean continued financing will be required. The filing is impactful for investors because it documents initial commercialization progress alongside clear liquidity constraints and dilution from extensive warrant and equity issuances.
TL;DR Significant liquidity and execution risks persist despite financings; Nasdaq bid-price notice increases near-term compliance risk.
The company discloses that cash is likely insufficient to fund operations for the next 12 months and explicitly states substantial doubt about its ability to continue as a going concern. Outstanding dilutive instruments are extensive (over 18.6M equity-classified warrant equivalents at June 30, 2025) and the company relies on future equity sales and a SEPA program. The July 31, 2025 Nasdaq notice for minimum bid price noncompliance adds an additional regulatory/compliance milestone the company must address. From a risk perspective, these are materially negative developments for shareholders until sustained commercial revenue or secured financing is demonstrated.
SeaStar Medical Holding Corporation (ICU) ha registrato le prime vendite commerciali del suo prodotto pediatrico per SCD, QUELIMMUNE, riconoscendo ricavi per $338 mila nel trimestre e $631 mila nei sei mesi chiusi il 30 giugno 2025. Il margine lordo 猫 stato di $311 mila nel trimestre e $604 mila nei sei mesi; il costo del venduto 猫 stato di $27 mila. La societ脿 ha riportato una perdita netta di $2,0 milioni nel trimestre e $5,8 milioni nei sei mesi, con una base media ponderata di azioni di 11,33 milioni e una perdita per azione base e diluita rispettivamente di $(0,18) e $(0,58).
Lo stato patrimoniale mostra $6,3 milioni in liquidit脿 e $8,4 milioni di attivit脿 totali al 30 giugno 2025, con un disavanzo accumulato di $145,3 milioni. La direzione afferma di non ritenere che la disponibilit脿 liquida attuale sia sufficiente a finanziare le operazioni per 12 mesi e indica notevoli dubbi sulla continuit脿 aziendale. Il documento descrive diversi aumenti di capitale nel 2025 (febbraio, giugno, proventi ATM) e offerte registrate successive a luglio/agosto 2025, e segnala il ricevimento di un avviso Nasdaq per non conformit脿 al prezzo minimo delle azioni, con un periodo di rimedio fino al 27 gennaio 2026.
SeaStar Medical Holding Corporation (ICU) inform贸 ventas comerciales iniciales de su producto pedi谩trico para SCD, QUELIMMUNE, reconociendo $338 mil en ingresos en el trimestre y $631 mil en los seis meses terminados el 30 de junio de 2025. El beneficio bruto fue de $311 mil en el trimestre y $604 mil en seis meses; el costo de los bienes vendidos fue de $27 mil. La compa帽铆a registr贸 una p茅rdida neta de $2,0 millones en el trimestre y $5,8 millones en los seis meses, con una base media ponderada de acciones de 11,33 millones y una p茅rdida por acci贸n b谩sica y diluida de $(0,18) y $(0,58), respectivamente.
El balance muestra $6,3 millones en efectivo y $8,4 millones en activos totales al 30 de junio de 2025, y un d茅ficit acumulado de $145,3 millones. La direcci贸n declara que no considera que el efectivo disponible sea suficiente para financiar las operaciones durante 12 meses y revela dudas sustanciales sobre la continuidad operativa. El informe detalla varias financiaciones de capital en 2025 (febrero, junio, ingresos ATM) y ofertas registradas posteriores en julio/agosto de 2025, y se帽ala la recepci贸n de un aviso de Nasdaq por incumplimiento del precio de oferta, con un periodo para subsanar hasta el 27 de enero de 2026.
SeaStar Medical Holding Corporation (ICU)電� 靻岇晞 SCD 鞝滍拡 QUELIMMUNE鞚� 齑堦赴 靸侅梾 韺愲Г毳� 氤搓碃頃橂┌ 攵勱赴 毵れ稖 $338觳�, 2025雲� 6鞗� 30鞚茧 雭濍倶電� 6臧滌洈 霃欖晥 $631觳滌潣 毵れ稖鞚� 鞚胳嫕頄堨姷雼堧嫟. 齑濎澊鞚奠潃 攵勱赴 $311觳�, 6臧滌洈 $604觳滌澊鞐堦碃 毵れ稖鞗愱皜電� $27觳滌澊鞐堨姷雼堧嫟. 須岇偓電� 攵勱赴 靾滌啇鞁� $2.0氚彪, 6臧滌洈 靾滌啇鞁� $5.8氚彪鞚� 旮半頄堨溂氅�, 臧�欷戫弶攴� 欤检嫕靾橂姅 11.33氚彪欤�, 旮半掣 氚� 頋劃 旮办 欤茧嫻靾滌啇鞁れ潃 臧侁皝 $(0.18) 氚� $(0.58)鞓�鞀惦媹雼�.
雽�彀寑臁绊憸靸� 2025雲� 6鞗� 30鞚� 旮办 順勱笀 $6.3氚彪, 齑濎瀽靷� $8.4氚彪鞚措┌ 雸勳爜鞝侅瀽電� $145.3氚彪鞛呺媹雼�. 瓴届榿歆勳潃 順� 鞙犽彊靹膘澊 12臧滌洈臧� 鞓侅梾鞚� 鞙犾頃橁赴鞐� 於╇秳頃橃 鞎婋嫟瓿� 韺愲嫧頃橂┌ 瓿勳啀旮办梾 臁挫啀鞐� 雽�頃� 靸侂嫻頃� 鞚橂鞚� 瓿店皽頄堨姷雼堧嫟. 鞝滌稖靹滊電� 2025雲勳潣 鞐煬 欤检嫕 鞛愱笀 臁半嫭(2鞗�, 6鞗�, ATM 靾橃澋)瓿� 2025雲� 7路8鞗旍潣 霌彪 瓿惦毳� 靸侅劯頌� 靹る獏頃橁碃 鞛堨溂氅�, 順戈皜 臧�瓴� 氙鸽嫭搿� 鞚疙暅 雮橃姢雼� 韱奠 靾橂牴 氚� 2026雲� 1鞗� 27鞚缄箤歆�鞚� 鞁滌爼 旮瓣皠鞚� 旮办灛頃橁碃 鞛堨姷雼堧嫟.
SeaStar Medical Holding Corporation (ICU) a d茅clar茅 les premi猫res ventes commerciales de son produit p茅diatrique pour SCD, QUELIMMUNE, enregistrant 338 000 $ de revenus pour le trimestre et 631 000 $ pour les six mois clos le 30 juin 2025. La marge brute s'est 茅lev茅e 脿 311 000 $ pour le trimestre et 604 000 $ pour les six mois ; le co没t des ventes 茅tait de 27 000 $. La soci茅t茅 a enregistr茅 une perte nette de 2,0 M$ pour le trimestre et de 5,8 M$ pour les six mois, avec une base moyenne pond茅r茅e d'actions de 11,33 millions et une perte par action de base et dilu茅e de (0,18 $) et (0,58 $), respectivement.
Le bilan indique 6,3 M$ de tr茅sorerie et 8,4 M$ d'actifs totaux au 30 juin 2025, et un d茅ficit cumul茅 de 145,3 M$. La direction indique qu'elle ne consid猫re pas la tr茅sorerie actuelle suffisante pour financer les op茅rations pendant 12 mois et r茅v猫le doutes importants sur la continuit茅 d'exploitation. Le d茅p么t d茅taille plusieurs financements en actions en 2025 (f茅vrier, juin, produits ATM) et des offres enregistr茅es ult茅rieures en juillet/ao没t 2025, et signale la r茅ception d'un avis du Nasdaq pour non-conformit茅 au prix d'appel, avec une p茅riode de r茅paration jusqu'au 27 janvier 2026.
SeaStar Medical Holding Corporation (ICU) meldete fr眉hzeitige kommerzielle Verk盲ufe ihres p盲diatrischen SCD-Produkts QUELIMMUNE und verbuchte im Quartal Einnahmen von $338.000 und $631.000 f眉r die sechs Monate zum 30. Juni 2025. Der Bruttogewinn lag bei $311.000 im Quartal und $604.000 f眉r sechs Monate; die Herstellungskosten betrugen $27.000. Das Unternehmen verzeichnete einen Nettoverlust von $2,0 Mio. im Quartal und $5,8 Mio. f眉r sechs Monate, mit einer gewichteten durchschnittlichen Aktienbasis von 11,33 Mio. und einem unverw盲sserten sowie verw盲sserten Ergebnis je Aktie von $(0,18) bzw. $(0,58).
Die Bilanz weist zum 30. Juni 2025 $6,3 Mio. in Barbest盲nden und $8,4 Mio. an Gesamtverm枚gen sowie ein kumuliertes Defizit von $145,3 Mio. aus. Das Management geht davon aus, dass die vorhandenen Mittel nicht ausreichen, um den Betrieb f眉r 12 Monate zu finanzieren, und offenbart erhebliche Zweifel an der Fortf眉hrungsf盲higkeit. Die Einreichung erl盲utert mehrere Eigenkapitalfinanzierungen 2025 (Februar, Juni, ATM-Erl枚se) und nachfolgende registrierte Angebote im Juli/August 2025 und vermerkt den Erhalt einer Nasdaq-Mitteilung wegen Nichteinhaltung des Mindestgebotspreises mit einer Nachfrist bis zum 27. Januar 2026.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO |
Commission File Number
(Exact name of Registrant as specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act ). Yes ☐ No
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As of August 6, 2025, the registrant had
SeaStar Medical Holding Corporation
June 30, 2025
Table of Contents
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PART I. |
FINANCIAL INFORMATION |
1 |
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Item 1. |
Condensed Consolidated Financial Statements (Unaudited) |
1 |
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Condensed Consolidated Balance Sheets (June 30, 2025 Unaudited) |
1 |
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Condensed Consolidated Statements of Operations (Unaudited) |
2 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity/(Deficit) (Unaudited) |
3 |
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Condensed Consolidated Statements of Cash Flows (Unaudited) |
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Notes to Condensed Consolidated Financial Statements (Unaudited) |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
31 |
Item 4. |
Controls and Procedures |
31 |
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PART II. |
OTHER INFORMATION |
32 |
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Item 1. |
Legal Proceedings |
32 |
Item 1A. |
Risk Factors |
32 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
35 |
Item 3. |
Defaults Upon Senior Securities |
35 |
Item 4. |
Mine Safety Disclosures |
35 |
Item 5. |
Other Information |
35 |
Item 6. |
Exhibits |
36 |
Signatures |
37 |
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PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
SeaStar Medical Holding Corporation
Condensed Consolidated Balance Sheets
(in thousands, except for share and per-share amounts)
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June 30, |
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ASSETS |
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LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) |
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Accounts payable |
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Notes payable, net of deferred financing costs |
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Liability classified warrants |
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Total current liabilities |
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Total liabilities |
|
|
|
|
|
|
||
Commitments and contingencies (Note 10) |
|
|
|
|
|
|
||
Stockholders’ equity/(deficit) |
|
|
|
|
|
|
||
Preferred stock - $ |
|
|
|
|
|
|
||
Common stock - $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ equity/(deficit) |
|
|
|
|
|
( |
) |
|
Total liabilities and stockholders’ equity/(deficit) |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except for share and per-share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Cost of goods sold |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other financing costs |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Change in fair value of convertible notes |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Change in fair value of warrants liability |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|||
Total other income (expense), net |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Loss before provision for income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Provision for income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share of common stock, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Changes in Stockholders’ Equity /(Deficit)
(unaudited)
(in thousands, except for share and per-share amounts)
|
|
For the Six months ended June 30, 2025 and 2024 |
|
|||||||||||||||||
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-In Capital |
|
|
Accumulated Deficit |
|
|
Total Stockholders’ Equity/(Deficit) |
|
|||||
Balance, December 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
Issuance of shares - conversion of convertible notes |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - exercise of warrants |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - equity offering (including pre-funded warrants), net of issuance costs |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
Issuance of shares - conversion of convertible notes |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - exercise of warrants |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, June 30, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Balance, December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||
Issuance of shares - exercise of warrants |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - equity offering (including pre-funded warrants), net of issuance costs |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - vesting of restricted stock units |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, March 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Issuance of shares - equity offering (including pre-funded warrants), net of issuance costs |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - standby equity purchase agreement commitment fee |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Issuance of shares - vesting of restricted stock units |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance, June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
SeaStar Medical Holding Corporation
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands, except for shares and per-share amounts)
|
|
Six Months Ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
|
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
|
|
||
Amortization of deferred financing costs |
|
|
|
|
|
|
||
Change in fair value of convertible notes (issued, converted and outstanding) |
|
|
|
|
|
|
||
Change in fair value of liability classified warrants (exercised and outstanding) |
|
|
( |
) |
|
|
|
|
Shares issued for the standby equity purchase agreement commitment fee |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Change in operating assets and liabilities |
|
|
|
|
|
|
||
Accounts receivables, net |
|
|
( |
) |
|
|
|
|
Inventory |
|
|
( |
) |
|
|
|
|
Prepaid expenses |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Accounts payable |
|
|
|
|
|
( |
) |
|
Accrued expenses |
|
|
( |
) |
|
|
|
|
Other liabilities |
|
|
|
|
|
|
||
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from issuance of convertible notes |
|
|
|
|
|
|
||
Payment of convertible notes |
|
|
|
|
|
( |
) |
|
Proceeds from issuance of shares |
|
|
|
|
|
|
||
Proceeds of pre-funded warrants |
|
|
|
|
|
|
||
Proceeds from exercise of warrants |
|
|
|
|
|
|
||
Payment of notes payable |
|
|
( |
) |
|
|
( |
) |
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net increase in cash |
|
|
|
|
|
|
||
Cash, beginning of period |
|
|
|
|
|
|
||
Cash, end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
|
|
$ |
|
||
Exercise of liability classified warrants |
|
$ |
|
|
$ |
|
||
Shares issued from conversion of convertible notes |
|
$ |
|
|
$ |
|
||
Issuance of convertible note warrants |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Note 1. Description of Business
Organization and Description of Business
SeaStar Medical Holding Corporation, a Delaware corporation (“SeaStar”) and its wholly owned subsidiary, SeaStar Medical, Inc., are collectively referred to as the “Company”. SeaStar Medical, Inc. was incorporated as a Delaware corporation in June 2007, and it is headquartered in Denver, Colorado. The Company is principally engaged in the research, development, and commercialization of a platform medical device technology designed to modulate inflammation in various patient populations. The initial target of this technology is for the treatment of patients with acute kidney injuries ("AKI"), but through additional Breakthrough Device Designation (“BDD”) from the Food and Drug Administration (“FDA”), has expanded into treatments of patients with cardiorenal syndrome awaiting left ventricular assist device implantation, patients with hepatorenal syndrome, patients with end stage renal disease and adult and pediatric patients undergoing cardiac surgery. The BDD enables the potential for a speedier pathway to approval and the ability to have more frequent and flexible meetings with the FDA.
The Company received FDA approval on February 21, 2024, under a Humanitarian Device Exemption (“HDE”) for the Company’s pediatric SCD therapy. It is the only FDA approved product for use in pediatric patients with AKI due to sepsis or a septic condition requiring kidney replacement therapy. The Company shipped its first commercial pediatric SCD (“QUELIMMUNE”) in July 2024. In addition, the Company is currently conducting a pivotal clinical trial to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).
On October 28, 2022, LMF Merger Sub, Inc., a wholly owned subsidiary of LMF Acquisition Opportunities, Inc. (“LMAO”) merged with and into SeaStar Medical, Inc. (the “Business Combination”), with SeaStar Medical, Inc. surviving the Business Combination as a wholly owned subsidiary of LMAO. Following the consummation of the Business Combination, LMAO was renamed “SeaStar Medical Holding Corporation.”
Basis of Presentation and Consolidation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal, recurring adjustments that are necessary to present fairly the Company’s results for the interim periods presented. The results from operations for the six months ended June 30, 2025, are not necessarily indicative of the results to be expected for the year ending December 31, 2025, or for any future annual or interim period.
The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the annual consolidated financial statements and the related notes for the year ended December 31, 2024. There have been no material changes in our significant accounting policies as described in our Annual Report on Form 10-K for the year ended December 31, 2024.
The interim unaudited condensed consolidated financial statements include the consolidated accounts of the Company’s wholly owned subsidiary, SeaStar Medical, Inc. All significant intercompany transactions have been eliminated in consolidation.
5
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
prior to the Reverse Stock Split were proportionally adjusted except for the Listed Warrants and the private placement warrants that were issued as part of the SPAC transaction that closed on October 28, 2022, which total
Segment Information
The Company is comprised of a single reportable segment, its Device Segment. This organizational structure aligns with how our Chief Operating Decision Maker (“CODM”), the Chief Executive Officer, manages the Company’s business, including resource allocation and performance assessment. The Company is focused entirely on the development, regulatory approval and commercialization of the Company’s adult and pediatric Selective Cytopheretic Devices (SCDs). The Company had a total of
All of the Company’s sales are located within the United States. As of the date of this report, the Company has obtained regulatory approval for commercial sales in the U.S. of QUELIMMUNE from the FDA. The Company does not have any inter-entity sales or transfers.
Liquidity and Going Concern
The Company incurred losses of $
The Company’s need for additional capital will depend in part on the scope and costs of its development activities. To date, the Company has generated insufficient revenue from the sales of its commercialized product, QUELIMMUNE to fund its operations. Its ability to generate meaningful product revenue will depend on the commercial successful launch of QUELIMMUNE and development and eventual commercialization of the adult SCD. Until such time, if ever, it expects to finance its operations through the sale of equity or debt, borrowing under credit facilities, or through potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to the Company when needed or on acceptable terms.
If the Company is unable to raise capital, it could be forced to delay, reduce, suspend, or cease its research and development programs or any future commercialization efforts, which would have a negative impact on its business, prospects, operating results and financial condition. The accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.
Risks and Uncertainties
The Company is subject to risks common to early-stage companies in the medical technology industry including,
6
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
but not limited to, new medical and technological innovations, dependence on key personnel, protection of proprietary technology, and product liability. There can be no assurance that the Company’s products or services will be accepted in the marketplace, nor can there be any assurance that any future products or services can be developed or deployed at an acceptable cost and with appropriate performance characteristics, or that such products or services will be successfully marketed, if at all. These factors could have a materially adverse effect on the Company’s future financial results, financial position and cash flows.
Note 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and reported amounts of revenues and expenses during the three and six months ended June 30, 2025. Significant estimates include the (i) unbilled clinical trial costs, and (ii) stock-based compensation expense. Although actual results could differ from those estimates, such estimates are developed based on the best information available to management and management’s best judgments at the time.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash. Periodically, the Company may maintain deposits in financial institutions in excess of government insured limits. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.
Accounts Receivable, net
The need for a credit loss allowance is evaluated each reporting period based on the Company’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in a credit loss. The Company uses an aging schedule method for estimating expected credit losses. As the Company just commenced commercial operations since July 1, 2024, with a limited customer base, the Company’s estimates are based on customer specific facts, until such time that the Company has developed sufficient collection history data in which to apply a portfolio-wide expected credit loss estimate based on an aging schedule (see Note 4).
Fair Value of Financial Instruments
The following provides a summary of those assets or liabilities for which the Company is required to measure at fair value either on a recurring basis, the valuation techniques and summary of inputs used to arrive at the measure of fair value. Changes in fair value of these assets or liabilities are recognized as a component of net income in the consolidated statements of operations. Changes in fair value of these assets or liabilities are considered unrealized gains or losses and therefore are classified as non-cash adjustments to reconcile net income to operating cash flows. Significant increases (decreases) in unobservable inputs used in fair value measurements could, in isolation, potentially result in a significantly lower or higher valuation for those assets or liabilities requiring recurring fair value measurements at each reporting date.
The Company uses a Black-Scholes option pricing model to estimate the fair value of liability classified warrants, using standard option pricing inputs such as the strike price of each warrant tranche, estimated volatility, time to maturity, and the risk-free interest rate. The risk-free interest rate is the U.S. Treasury rate at the date of issuance, and the time to maturity is based on the contractual life at the date of issuance, which is an interpolated value based on the remaining term of each individual instrument. The change in fair value of the liability classified warrants in each reporting period is recorded to the change in fair value of liability classified warrants in the consolidated statements of operations.
7
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Revenue Recognition
Overall
Under ASC 606, Revenues from Contracts with Customers ("Topic 606") the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of Topic 606, the Company evaluates the following criteria: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) performance obligations are satisfied.
At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation. Goods and services that are determined not to be distinct are combined with other promised goods and services until a distinct combined performance obligation is identified. The Company then allocates the transaction price to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The estimate of the transaction price for each contract includes all variable consideration to which the Company expects to be entitled, subject to the constraint on variable consideration. The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized at the contract level is not significant.
The Company records any payments received from customers prior to the Company fulfilling its performance obligation(s) as contract obligations. Amounts expected to be recognized as revenue within the one year following the balance sheet date are classified as current contract obligations. Amounts not expected to be recognized as revenue within the one year following the balance sheet date are classified as contract obligations, net of current portion. See Note 3 – Revenue and Contract Obligations for further details.
Product Sales Revenue
The Company sells its products directly to end-user qualified customers using the Company’s own internal commercial/sales resources.
8
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
The Company will continue to monitor all of the above as the Company continues to commercialize and increase its customer base, which could result in each distributor or end-user customer agreement having its own unique terms and conditions, that will potentially impact the timing and amount of revenue recognition pursuant to U.S. GAAP.
Cost of Goods Sold
Prior to July 2024, the Company manufactured/assembled QUELIMMUNE and adult SCDs only for research oriented and/or clinical trial related activities. Inventory purchased prior to July 2024 was expensed as a period expense at the time of purchase as a research and development expense. Accordingly, all QUELIMMUNE units sold prior to the three months ended June 30, 2025, had
As the Company continues to procure inventory, the Company will recognize the cost of materials to inventory. Use of inventory for QUELIMMUNE will be charged to cost of goods sold while inventory used for adult SCDs will be charged to research and development upon shipment.
Funded Research & Development Expense
During the three months ended June 30, 2025, the Company entered into an agreement to provide contract research services to an outside party, which involves a study of the Company's selective cytopheretic device relating to patients with severe, chronic heart failure. The Company is able to bill the outside party for a certain portion of the costs incurred to provide these services. The Company will own and is able to benefit from the knowledge gained from the results of this study. Accordingly, the Company will account for any funds paid by the outside party to the Company as a reimbursed expense, in accordance with ASC 730-20 as a funded research and development arrangement. Accordingly, any amounts incurred and billed will offset the Company's operating expenses categorized as research and development expense on the Company’s condensed consolidated statement of operations for the three and six months ended June 30, 2025. The reimbursed expenses for the three and six months ended June 30, 2025 totaled approximately $
Emerging Growth Company Status
The Company is an “emerging growth company”, as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Under the JOBS Act, emerging growth companies can take advantage of an extended transition period for complying with new or revised accounting standards, delaying the adoption of these accounting standards until they apply to private companies. The Company has elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it is (1) no longer an emerging growth company or (2) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.
Recently issued accounting standards
Accounting Standards Update 2024-03 — In November 2024, the FASB issued ASU 2024-03 - Income Statement - Reporting Comprehensive Income – Expense Disaggregation (Subtopic 220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 requires the disclosure of additional information related to certain costs and expenses, including amounts of inventory purchases, employee compensation, and depreciation and amortization included in each income statement line item. The ASU is effective for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial statements and disclosures.
9
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Accounting Standards Update 2023-09 — In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures. The amendments in this update are effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently assessing the impact of this guidance on its consolidated financial statements and disclosures, however the impact from the adoption of this guidance, if any, will not be reflected until the Company's Annual Report to Form 10-K for the year-ending December 31, 2025, due to the Company's net loss position and 100% valuation allowance for all deferred tax assets.
Note 3. Revenues and Contract Obligations
|
|
|
Six Months Ended June 30, |
|
|||||
($ in thousands) |
|
|
2025 |
|
|
2024 |
|
||
Contract liabilities, beginning of period |
|
|
$ |
|
|
$ |
|
||
Consideration received |
|
|
|
|
|
|
|
||
Consideration refunded |
|
|
|
|
|
|
( |
) |
|
Revenue |
|
|
|
|
|
|
|
||
Contract liabilities, end of period |
|
|
$ |
|
|
$ |
|
||
Revenue by Geographic Location
The Company’s sales are entirely in the United States of America, as it does not have any regulatory approval to sell elsewhere as of June 30, 2025.
Note 4. Accounts Receivable, net
The table below presents the opening and closing balances of accounts receivable, on a gross and net basis, with the total change in expected credit losses.
($ in thousands) |
|
Accounts Receivable, Gross |
|
Expected Credit Losses |
|
Accounts Receivable, Net |
|
|||
December 31, 2024 |
|
$ |
|
$ |
— |
|
$ |
|
||
Change in accounts receivable, net |
|
|
|
|
( |
) |
|
|
||
June 30, 2025 |
|
$ |
|
$ |
( |
) |
$ |
|
||
Note 5. Accrued Expenses
Accrued expenses consisted of the following amounts as of June 30, 2025, and December 31, 2024:
($ in thousands) |
June 30, |
|
|
December 31, |
|
||
Accrued bonus |
$ |
|
|
$ |
|
||
Accrued director compensation |
|
|
|
|
|
||
Accrued research and development |
|
|
|
|
|
||
Other |
|
|
|
|
|
||
Total accrued expenses |
$ |
|
|
$ |
|
||
10
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Note 6. Notes Payable
Insurance Financing
In October 2024, the Company entered into a financing arrangement with a lender to finance a portion of the annual premium of an insurance policy in the amount of $
Note 7. Equity Transactions
June 2025 Offering
In June 2025, the Company did a best efforts public offering (the “June 2025 Offering”) pursuant to which the Company issued aggregate of (i)
The Company received aggregate gross proceeds from the June 2025 Offering of approximately $
The Series A Warrants and Series B Warrants were immediately exercisable with the Series A warrants expiring in June 2030 and the Series B Warrants expiring in December 2026.
The Company paid approximately $
In accordance with ASC 815-40, Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all the different warrants issued in connection with the June 2025 Offering met the conditions for equity classification and were included as a component of stockholders’ equity (deficit).
Standby Equity Purchase Agreement
On April 25, 2025, the Company entered into a standby equity purchase agreement (“Common Stock Purchase Agreement”) and related registration rights agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), collectively the “SEPA”. Pursuant to the Common Stock Purchase Agreement, the Company has the right, but not the obligation, to direct Lincoln Park to purchase up to $
The Company controls the timing and amount of any sales to Lincoln Park, which depend on a variety of factors including, among other things, market conditions, the trading price of the Company’s common stock, and determinations by the Company as to appropriate sources of funding for its business and operations. However, Lincoln Park’s obligation to purchase shares is subject to certain conditions, including the daily trading volume of the
11
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Company’s stock. In all instances, the Company may not sell shares of Common Stock under the Purchase Agreement if it would result in Lincoln Park and its affiliate beneficially owning more than
As part of the SEPA, the Company agreed to pay Lincoln Park
The Company evaluated the contract that includes the right to require Lincoln Park to purchase shares of common stock in the future (“put right”) considering the guidance in ASC 815-40, Derivatives and Hedging — Contracts on an Entity’s Own Equity and concluded that it is an equity-linked contract that does not qualify for equity classification, and therefore requires fair value accounting. The Company analyzed the terms of the freestanding put right and concluded that it has an immaterial value as of June 30, 2025.
The Company has not yet raised any capital nor issued any shares from the use of the SEPA.
February 2025 Offering
In January 2025, the Company entered into a Securities Purchase Agreement with an institutional investor (the "Q1 2025 SPA"), pursuant to which the Company issued on February 3, 2025, to the investor, (i) in a registered direct offering,
The Company received aggregate gross proceeds from the February 2025 Offering of approximately $
The February 2025 Common Warrants became exercisable on
Prior to their exercise, the February 2025 Pre-Funded Warrants had dividend participation rights, and any unexercised pre-funded warrants are included in the Company's weighted-average shares outstanding for calculation the Company's net loss per share.
In connection with the January 2025 Offering, the Company amended the exercise price of the Series A and Series B common warrants (collectively “January 2024 Warrants”), issued in a financing transaction with the institutional investor in January 2024, to $
The Company paid approximately $
12
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
In accordance with ASC 815-40, Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all the different warrants issued or amended in connection with the February 2025 Offering met the conditions for equity classification and were included as a component of stockholders’ equity / (deficit).
At-The-Market Offering
On August 20, 2024, the Company entered into an At-The-Market Offering Agreement (the “ATM Agreement”) with Wainwright as sales agent, to sell shares of its common stock, from time to time, through an “at the market offering” program under which Wainwright will act as sales agent. The sales, if any, of the Company’s Common Stock made under the ATM Agreement will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on or through the Nasdaq Capital Market or on any other existing trading market for the Company’s common stock (the “ATM”).
Through June 30, 2025, the Company has raised approximately $
Note 8. Warrants
The Company issued warrants in connection with various financing transactions.
|
|
June 30, |
|
|
December 31, |
|
||
Liability Classified Warrants |
|
|
|
|
|
|
||
Private Placement Warrants |
|
|
|
|
|
|
||
PIPE Investor Warrants |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Equity Classified Warrants |
|
|
|
|
|
|
||
June 2025 Warrants |
|
|
|
|
|
|
||
February 2025 Warrants |
|
|
|
|
|
|
||
July 2024 Warrants |
|
|
|
|
|
|
||
January 2024 Warrants |
|
|
|
|
|
|
||
Public Stockholders’ Warrants |
|
|
|
|
|
|
||
Legacy Warrants |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
Grand Total |
|
|
|
|
|
|
||
The following tables provide the weighted-average strike price and time to maturity for each warrant share
13
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
equivalent outstanding for each warrant tranche as of June 30, 2025 and December 31, 2024(*):
June 30, 2025 |
|
Warrant Share Equivalents |
|
|
Weighted-Average Strike Price |
|
|
Weighted-Average Time to Maturity |
|
|||
Liability Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Private Placement Warrants |
|
|
|
|
$ |
|
|
|
|
|||
PIPE Investor Warrants |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Equity Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
June 2025 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
February 2025 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
July 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
January 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Public Stockholders’ Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Legacy SeaStar Inc. Warrants |
|
|
|
|
$ |
|
|
|
|
|||
December 31, 2024 |
|
Warrant Share Equivalents |
|
|
Weighted-Average Strike Price |
|
|
Weighted-Average Time to Maturity |
|
|||
Liability Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
Private Placement Warrants |
|
|
|
|
$ |
|
|
|
|
|||
PIPE Investor Warrants |
|
|
|
|
$ |
|
|
|
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Equity Classified Warrants |
|
|
|
|
|
|
|
|
|
|||
July 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
January 2024 Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Public Stockholders’ Warrants |
|
|
|
|
$ |
|
|
|
|
|||
Legacy SeaStar Inc. Warrants |
|
|
|
|
$ |
|
|
|
|
|||
* - The above warrant tranches can include classes of warrants with original or amended terms of between eighteen months to five years.
Below is the warrant activity for the six months ended June 30, 2025, for those warrants with activity during the six months ended June 30, 2025:
|
|
June 2025 Warrants |
|
|
June 2025 Pre-Funded Warrants |
|
|
February 2025 Warrants |
|
|
February 2025 Pre-Funded Warrants |
|
|
||||
Outstanding as of December 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issuance |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
|
||
Forfeited / cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding as of June 30, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
During the three and six months ended June 30, 2025, the Company incurred a gain of approximately $
Note 9. Stock-Based Compensation Awards
The following table sets forth the total stock-based compensation cost included in the Company’s unaudited
14
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
condensed consolidated statements of operations for the periods indicated:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
($ in thousands) |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total stock-based compensation |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Equity Incentive Plan - Summary
2022 Omnibus Incentive Plan
The Company’s Board of Directors adopted, and the shareholders approved the 2022 Omnibus Incentive Plan to provide long-term incentive for its employees and non-employee service providers. The vesting of stock options is stated in each individual grant agreement, which is generally one to
2019 Stock Incentive Plan
The Company’s Board of Directors adopted the 2019 Stock Incentive Plan on February 25, 2019, to provide long-term incentive for its employees and non-employee service providers. The Stock Incentive Plan was terminated on October 28, 2022, and no further awards were granted under such plan.
Stock Options
Option activity for the period ended June 30, 2025, is as follows:
2022 Omnibus Incentive Plan - Stock Options
|
|
|
|
Options |
|
|
Weighted-Average Exercise Price |
|
|
Total Intrinsic Value |
|
|
Weighted-Average Remaining Contractual Life (Years) |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited / cancelled |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at June 30, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Vested and exercisable at June 30, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
2019 Omnibus Incentive Plan - Options
|
|
|
|
Options |
|
|
Weighted-Average Exercise Price |
|
|
Total Intrinsic Value |
|
|
Weighted-Average Remaining Contractual Life (Years) |
|
||||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Forfeited / cancelled |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding at June 30, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
Vested and exercisable at June 30, 2025 |
|
|
|
|
|
|
$ |
|
|
$ |
|
|
|
|
||||
15
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Restricted Stock Units
A summary of the Company’s restricted stock unit (“RSU”) activity is as follows:
2022 Omnibus Incentive Plan - RSUs
|
|
|
|
Number of RSU |
|
|
Weighted-Average Grant Date Fair Value (per share) |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
|
|
||
Vested |
|
|
|
|
( |
) |
|
|
|
|
Forfeited / cancelled |
|
|
|
|
|
|
|
|
||
Outstanding at June 30, 2025 |
|
|
|
|
|
|
$ |
|
||
2019 Stock Incentive Plan - RSUs
|
|
|
|
Number of RSU |
|
|
Weighted-Average Grant Date Fair Value (per share) |
|
||
Outstanding at December 31, 2024 |
|
|
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
|
|
||
Vested |
|
|
|
|
( |
) |
|
|
|
|
Forfeited / cancelled |
|
|
|
|
|
|
|
|
||
Outstanding at June 30, 2025 |
|
|
|
|
|
|
$ |
|
||
Note 10. Commitments and Contingencies
Lease Agreements
The Company is part of a membership agreement for shared office space and can cancel at any time. Rent expense was approximately $
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties, and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business.
2024 Securities Class Action Lawsuit
On July 5, 2024, Forrest A K Wells (the “Plaintiff”), a purported stockholder of the Company, filed a putative class action complaint in the United States District Court for the State of Colorado, captioned Wells v. SeaStar Medical Holding Corporation et al, Case No. 1:24-cv-0187 (D. Colorado) (the “Class Action”). The Class Action alleges that the Company, its Chief Executive Officer and former Chief Financial Officer made or caused to be made material misstatements or omissions regarding the Company’s business and operations, allegedly culminating in the Company’s restatement of its consolidated financial statements, disclosed in a Form 8-K and filed on March 27, 2024. The Class Action asserts claims pursuant to the Securities Exchange Act of 1934, including Section 10(b), Rule
16
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
10b-5 promulgated thereunder and Section 20(a). The Class Action seeks to recover, among other remedies, compensatory damages. The Company intends to vigorously defend the action.
The Company has not recognized a contingent liability for this Class Action event as it does not qualify for the recognition criteria under ASC 450, Contingencies.
Note 11. Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). Inputs used to measure fair value are classified into the following hierarchy:
Level 1 – quoted prices in active markets for identical assets and liabilities.
Level 2 – other significant observable inputs (including quoted prices for similar assets and liabilities, interest rate, credit risk, etc.).
Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of assets and liabilities).
The fair value of the warrants liability is classified as Level 3 in the fair value hierarchy.
Fair Value Measurement Hierarchy
The following table presents the Company’s financial assets and/or liabilities that were accounted for at fair value on a recurring basis as of June 30, 2025 and December 31, 2024, by level within the fair value hierarchy. There were no non-recurring fair value measurements, as the Company does not have any long-lived assets, including fixed assets, intangible assets, or goodwill which can require non-recurring measurements for impairment.
Summary of Level 3 Input Changes
|
|
Fair Value Measurements at June 30, 2025 |
|
|||||||||||||
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liability classified warrants |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Fair Value Measurements at December 31, 2024 |
|
|||||||||||||
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
||||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Liability classified warrants |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table presents the changes in the forward option-prepaid forward contracts, convertible notes measured at fair value, warrants liability, and the notes derivative liability for the six months ended June 30, 2025 (in thousands):
17
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
Level 3 Roll Forward |
|
|
|
Liability Classified Warrants |
|
|
Balance December 31, 2024 |
|
|
|
$ |
|
|
Additions |
|
|
|
|
|
|
Cash paid to settle |
|
|
|
|
|
|
Shares issued upon conversion or exercise |
|
|
|
|
|
|
Changes in fair value |
|
|
|
|
( |
) |
Balance June 30, 2025 |
|
|
|
$ |
|
|
Level 3 Inputs
For assets or liabilities for which the Company is required to remeasure the fair value on a recurring basis at each reporting date, generally the Company is required to disclose certain quantitative data related to the inputs used at the most recent reporting period date. However, for those assets or liabilities for which the Company has elected to take the fair value option in accordance with ASC 825, Financial Instruments, then such quantitative disclosures are not required.
Liability Classified Warrants
The liability classified warrants as of June 30, 2025 and December 31, 2024, include three classes of warrants, and therefore, the range of assumptions used has been provided. Significant assumptions used in valuing warrants which require liability classification were as follows as of June 30, 2025 and December 31, 2024.
|
|
June 30, |
|
|
|
December 31, |
|
||
|
|
2025 |
|
|
|
2024 |
|
||
Expected volatility |
|
|
% |
|
|
|
% |
||
Equivalent term |
|
|
|
|
|
|
|
||
Risk-free rate |
|
|
% |
|
|
|
% |
||
Dividend yield |
|
|
% |
|
|
|
% |
||
Stock price |
$ |
|
|
|
$ |
|
|
||
Strike price |
$ |
|
|
|
$ |
|
|
||
Note 12. Income Taxes
In accordance with U.S. GAAP, a valuation allowance should be provided if it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The Company’s ability to realize the benefit of its deferred tax assets will depend on the generation of future taxable income. Except as noted below, due to the uncertainty of future profitable operations and taxable income, the Company has recorded a full valuation allowance against its net deferred tax assets. The Company has recognized an insignificant provision for certain minimum state taxes of approximately $
The Company believes its tax filing position and deductions related to tax periods subject to examination will be sustained under audit and, therefore, has no reserve for uncertain tax positions.
Note 13. Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share (in thousands except share and per share information):
18
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
|
|
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|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
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|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Net loss |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average shares outstanding - basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The following weighted-average outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:
|
|
|
|
As of June 30, |
|
|||||||
|
|
|
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|
2025 |
|
|
2024 |
|
||
Liability classified warrants |
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|
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|
||
Equity classified warrants |
|
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||
Employee based options to purchase common stock |
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Unvested employee based restricted stock units |
|
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Total |
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||
Note 14. Segment Reporting
The Company is comprised of a single reportable segment, its Device Segment. This organizational structure aligns with how our Chief Operating Decision Maker (“CODM”), the Chief Executive Officer, manages the Company’s business, including resource allocation and performance assessment. The Company is focused entirely on the development, regulatory approval and commercialization of the Company’s adult and pediatric Selective Cytopheretic Devices (SCDs). The Company had total assets of $
All of the Company’s sales are located within the United States. As of the date of this report, the Company has obtained regulatory approval for commercial sales in the U.S. of QUELIMMUNE from the FDA. The Company does not have any inter-entity sales or transfers.
The following table represents the Company’s sole segment’s operating results for the six months ended June 30, 2025 and 2024, respectively(*).
19
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
|
|
|
Three Months Ended June 30, 2025 |
|
|
Six Months Ended June 30, |
|
||||||||||||
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2025 |
|
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2024 |
|
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2025 |
|
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2024 |
|
||||
|
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|
|
|
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|
|
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|
||||
Net Revenue |
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
$ |
|
|
||||
Cost of goods sold |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
$ |
|
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
||||
General and administrative |
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
$ |
|
|
||||
Loss from operations |
|
$ |
|
( |
) |
|
$ |
|
( |
) |
$ |
|
( |
) |
|
$ |
|
( |
) |
(*) -
Note 15. Subsequent Events
July 2025 Public Offering
On July 10, 2025, the Company entered into a Securities Purchase Agreement (the “July 2025 SPA”) with certain institutional investors (the “July 2025 Purchasers”), pursuant to which the Company sold and issued to the July 2025 Purchasers, (i) in a registered direct offering,
The combined offering price for each share of Common Stock and accompanying July 2025 Common Warrant was $
The July 2025 Common Warrants are exercisable upon issuance and will expire on the fifth anniversary of the effective date of the registration statement filed by the Company registering the resale of the shares of common stock underlying the Common Warrants. The July 2025 Pre-Funded Warrants will not expire and are exercisable commencing on the date of issuance and at any time until all of the July 2025 Pre-Funded Warrants are exercised in full.
Pursuant to an engagement agreement (as amended, the “Engagement Agreement”) with H.C. Wainwright & Co., LLC (the “July 2025 Placement Agent”), the Company agreed to pay the July 2025 Placement Agent in connection with the July 2025 SPA (i) a cash fee equal to
Also pursuant to the Engagement Agreement, the Company, in connection with the July 2025 Offering, agreed to issue to the Placement Agent or its designees warrants (the “July 2025 Placement Agent Warrants”) to purchase up to an aggregate of
August 2025 Registered Direct Offering
20
SeaStar Medical Holding Corporation
Notes to the Condensed Consolidated Financial Statements (Unaudited)
June 30, 2025
On July 31, 2025, the Company entered into a Securities Purchase Agreement (the “August 2025 SPA”) with certain institutional investors (the “August 2025 Purchasers”), pursuant to which the Company sold and issued to the August 2025 Purchasers, (i) in a registered direct offering,
Pursuant to the Engagement Agreement with H.C. Wainwright & Co., LLC (the “August 2025 Placement Agent”), the Company agreed to pay the August 2025 Placement Agent in connection with the August 2025 Offering (i) a cash fee equal to
Shareholder Approval of Additional 2022 Omnibus Incentive Plan Shares
On July 3, 2025, at the annual meeting of the stockholders, the stockholder approved an amendment and restatement of the Company’s 2022 Omnibus Equity Incentive Plan (the “Plan”) to (i) increase the number of authorized shares of common stock ("Common Stock") from
Nasdaq Bid Price Requirement Notice
On July 31, 2025, the Company received a letter from Nasdaq notifying us that the Company was not in compliance with the $
21
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis are intended to help you understand our business, financial condition, results of operations, liquidity, and capital resources. You should read this discussion in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024 (filed March 27, 2025) and Form 10-K/A for the year ended December 31, 2024 (filed April 23, 2025).
In addition to historical financial analysis, this discussion and analysis contains forward-looking statements based upon current expectations that involve risks, uncertainties, and assumptions, as described under the heading “Cautionary Note Regarding Forward Looking Statements.” Actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of various factors, risks and uncertainties, including those set forth under “Risk Factors” included elsewhere (or incorporated by reference) in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2024. Unless the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” to “SeaStar Medical”, “we”, “us”, “our,” and “the Company” are intended to mean the business and operations of SeaStar Medical Holding Corporation and its consolidated subsidiaries following the Business Combination.
Overview
On October 28, 2022, LMAO consummated a series of transactions that resulted in the combination of LMF Merger Sub, Inc. and the Predecessor pursuant to an Agreement and Plan of Merger. Immediately upon consummation of the Business Combination, LMAO was renamed SeaStar Medical Holdings Corporation (as defined above).
We are a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. Our Selective Cytopheretic Device (“SCD”) is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. It has broad potential applications for patients suffering from both acute and chronic kidney disease as well as cardiovascular and other serious inflammatory diseases.
We received Food and Drug Administration (“FDA”) approval on February 21, 2024, under a Humanitarian Device Exemption (“HDE”) for our pediatric SCD therapy. It is the only FDA approved product for use in pediatric patients with acute kidney injury (“AKI”) due to sepsis or a septic condition requiring kidney replacement therapy. We shipped our first commercial pediatric SCD (“QUELIMMUNE”) in July 2024. In addition, we are currently conducting a pivotal clinical trial to assess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacement therapy (“CRRT”).
Our SCD therapy has been awarded Breakthrough Device Designation (“BDD”) for six therapeutic indications by the FDA, including the use of the SCD therapy for adult patients with AKI, patients with cardiorenal syndrome awaiting left ventricular assist device (“LVAD”) implantation, patients with hepatorenal syndrome, patients with end stage renal disease (“ESRD”) and adult and pediatric patients undergoing cardiac surgery. The BDD enables the potential for a speedier pathway to approval and the ability to have more frequent and flexible meetings with the FDA.
The inflammatory response is essential to the healing process of critical organs; however, the overactivation of inflammatory cells, which can be triggered by many different bodily insults such as trauma, surgery or infection, can send the body into shock and cause severe damage to a variety of critical organs such as the heart, lungs and kidney. Central to inflammation are the cells within blood and lymph circulatory systems, called white blood cells (primarily neutrophils and monocytes). In a normal inflammatory response, neutrophils are the first immune cells to arrive at the site and are key to the entire immune response that kills pathogens and promotes tissue repair. These inflammatory cells release chemicals (cytokines) that trigger the immune system to eliminate foreign pathogens or damaged tissue, enhancing the immune response.
If the inflammatory response becomes excessive and dysregulated (referred to as proinflammatory), the inflammatory cells will continue to produce cytokines and other damaging molecules, further enhancing the dysregulated immune response, and altering feedback mechanisms that regulate the immune system. This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including the heart, lung, kidney, liver, and even death. This hyperinflammatory response is also known as the “cytokine storm,” referring to the body’s reaction to the category of small-secreted proteins
22
released by hyperinflammatory cells that affect communication between cells. Currently, there are no therapeutic options that specifically neutralize the white blood cells that are primarily responsible for the destructive hyperinflammatory response.
Clinicians typically address hyperinflammation with therapies that are either immunosuppressive or that target one cytokine, both of which are generally suboptimal in the treatment of hyperinflammation. We believe our technology has the potential to overcome limitations in existing anti-inflammatory treatments and address the challenge of selectively targeting activated neutrophils and monocytes. Clinical and preclinical studies conducted over the last 15 years have demonstrated that our SCD therapy can modulate the degree of activity of proinflammatory cells to help reduce tissue damage and speed the repair and recovery of organ function. Data from our trials demonstrated that the use of our SCD therapy to reverse the cytokine storm in more than 150 pediatric and adult patients with acute kidney injury on CRRT reduced mortality rates by 50%, and of those patients who survived 60 days, none have required dialysis. We believe our SCD therapy has the potential to transform the treatment of acute organ failure in the intensive care unit (“ICU”) and to improve organ function in patients with chronic kidney disease, certain cardiovascular diseases, and other serious inflammatory diseases.
Preclinically, we evaluated our SCD therapy in various animal models representing multiple hyperinflammatory indications, including acute myocardial infarction, intracranial hemorrhage, chronic heart failure, sepsis, and acute respiratory distress syndrome. The animal models demonstrated the inflammatory response and how it was modified by our SCD therapy. We will continue to explore the application of our SCD therapy across a broad range of indications where proinflammatory activated neutrophils and monocytes contribute to disease progression or severity in both acute and chronic indications.
We are leveraging our patent protected and scalable SCD therapy platform to develop proprietary treatments that are organ agnostic and target both acute and chronic indications. The SCD therapy is delivered via an extracorporeal synthetic membrane device that easily integrates into existing CRRT systems that are commonly employed for patients with acute organ injury in hospitals, including in ICUs throughout the United States. It also has the potential to be integrated into kidney dialysis systems for chronic kidney disease patients receiving renal replacement therapy at centers throughout the United States. We believe that the ease of use and broad applicability of the therapy across multiple disease states should enable us to capture a sizable market for our SCD therapy with increasingly favorable economics.
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.
There is a substantial clinical need for safe and effective control of hyperinflammation and we believe that our first-in-class SCD therapy can address the large potential market of over one million patients each year that face life-threatening hyperinflammatory conditions, including organ failure and potential loss of life.
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.
As of June 30, 2025, and December 31, 2024, we had cash of $6.3 million and $1.8 million, respectively.
Our accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and liabilities in the normal course of business. Our unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern.
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
23
statements for the six months ended June 30, 2025, included elsewhere in this Form 10-Q for additional information on our assessment.
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.
Key Components of Results of Operations
Revenue
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.
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.
Research and Development Expenses
Since inception, we have focused our resources on research and development activities, including conducting preclinical studies and clinical trials, and developing our process and activities related to regulatory filings for our products. Subject to the availability of additional funding, we plan to further increase our research and development expenses for the foreseeable future as we continue the development of our SCD as well as a next generation SCD. Research and Development expenses also include salaries and related costs for employees in clinical and medical affairs roles, which include stock-based compensation expenses and benefits for such employees.
The Company is continuously reviewing research and development spend to ensure it is aligned with the Company's objectives.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related costs for employees in executive, sales and commercial and finance roles, which also include stock-based compensation expenses and benefits for such employees.
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.
Loss from Operations and Operating Margin
Loss from operations consists of our gross profit less our operating expenses. Operating margin is loss from the operations as a percentage of our net sales.
24
Other Income (Expense), Net
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).
Factors Affecting Operating Results
We believe that our performance and future success depend on a number of factors that present significant opportunities for us but also pose risks and challenges. Please see the factors discussed elsewhere in this Form 10-Q, including those discussed in Part II, Item 1A, “Risk Factors,” for additional information.
Results of Operations
Comparison of the Three Months Ended June 30, 2025 to the Three Months Ended June 30, 2024
The following table sets forth a summary of our results of operations. This information should be read together with our unaudited condensed consolidated financial statements and related Notes included elsewhere in this Form 10-Q.
|
|
|
Three Months |
|
|
|
|
|
|
|
|
||||||||
|
|
|
June 30, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2025 |
|
|
|
2024 |
|
|
|
$ |
|
|
% |
|
||||
Revenue |
|
|
$ |
338 |
|
|
|
$ |
— |
|
|
|
$ |
338 |
|
|
* |
|
|
Cost of goods sold |
|
|
|
27 |
|
|
|
|
— |
|
|
|
|
27 |
|
|
* |
|
|
Gross profit |
|
|
|
311 |
|
|
|
|
— |
|
|
|
|
311 |
|
|
* |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
1,037 |
|
|
|
|
2,334 |
|
|
|
|
(1,297 |
) |
|
|
(56 |
)% |
General and administrative |
|
|
|
1,030 |
|
|
|
|
2,335 |
|
|
|
|
(1,305 |
) |
|
|
(56 |
)% |
Total operating expenses |
|
|
|
2,067 |
|
|
|
|
4,669 |
|
|
|
|
(2,602 |
) |
|
|
-56 |
% |
Loss from operations |
|
|
|
(1,756 |
) |
|
|
|
(4,669 |
) |
|
|
|
2,940 |
|
|
|
-63 |
% |
Total other income (expense) |
|
|
|
(246 |
) |
|
|
|
1,436 |
|
|
|
|
(1,682 |
) |
|
|
-117 |
% |
Loss before income tax provision |
|
|
|
(2,002 |
) |
|
|
|
(3,233 |
) |
|
|
|
1,258 |
|
|
|
-39 |
% |
Income tax provision (benefit) |
|
|
|
— |
|
|
|
|
3 |
|
|
|
|
(3 |
) |
|
|
-100 |
% |
Net loss |
|
|
$ |
(2,002 |
) |
|
|
$ |
(3,236 |
) |
|
|
$ |
1,261 |
|
|
|
-39 |
% |
(*) – there was no activity for the three months ended June 30, 2024.
Revenue, Cost of Goods Sold and Gross Profit
Revenue increased $0.3 million, while gross profit also increased $0.3 million for the three months ended June 30, 2025, compared to the same period ending June 30, 2024. This was made possible because we obtained an HDE for QUELIMMUNE in February 2024, and final regulatory clearance to sell commercially from the FDA under this HDE in July 2024. The Company has six customer sites for QUELIMMUNE as of June 30, 2025.
Research and Development Expenses
The following table discloses the breakdown of research and development expense for the three months ended June 30, 2025 compared to the same period ending June 30, 2024:
25
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
June 30, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2025 |
|
|
|
2024 |
|
|
|
$ |
|
|
% |
|
||||
Clinical trials |
|
$ |
|
633 |
|
|
$ |
|
1,325 |
|
|
$ |
|
(692 |
) |
|
|
(52 |
)% |
External services |
|
|
|
48 |
|
|
|
|
309 |
|
|
|
|
(261 |
) |
|
|
(84 |
)% |
Payroll and personnel expenses |
|
|
|
304 |
|
|
|
|
633 |
|
|
|
|
(329 |
) |
|
|
(52 |
)% |
Other research and development expenses |
|
|
|
52 |
|
|
|
|
67 |
|
|
|
|
(15 |
) |
|
|
(22 |
)% |
|
|
$ |
|
1,037 |
|
|
$ |
|
2,334 |
|
|
$ |
|
(1,297 |
) |
|
|
(56 |
)% |
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.
General and Administrative Expenses
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.
Other Income (Expense)
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").
Income Tax Provision (Benefit)
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.
Net Loss
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 $1.2 million has been disclosed in the above discussion.
26
Comparison of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
June 30, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2025 |
|
|
|
2024 |
|
|
|
$ |
|
|
% |
|
||||
Revenue |
|
|
$ |
631 |
|
|
|
$ |
— |
|
|
|
$ |
631 |
|
|
* |
|
|
Cost of goods sold |
|
|
$ |
27 |
|
|
|
$ |
— |
|
|
|
$ |
27 |
|
|
* |
|
|
Gross profit |
|
|
$ |
604 |
|
|
|
$ |
— |
|
|
|
$ |
604 |
|
|
* |
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
3,468 |
|
|
|
|
4,031 |
|
|
|
|
(563 |
) |
|
|
(14 |
)% |
General and administrative |
|
|
|
2,716 |
|
|
|
|
4,588 |
|
|
|
|
(1,872 |
) |
|
|
(41 |
)% |
Total operating expenses |
|
|
|
6,184 |
|
|
|
|
8,619 |
|
|
|
|
(2,435 |
) |
|
|
-28 |
% |
Loss from operations |
|
|
|
(5,580 |
) |
|
|
|
(8,619 |
) |
|
|
|
3,066 |
|
|
|
-36 |
% |
Total other expense |
|
|
|
(191 |
) |
|
|
|
(7,311 |
) |
|
|
|
7,120 |
|
|
|
-97 |
% |
Loss before income tax provision |
|
|
|
(5,771 |
) |
|
|
|
(15,930 |
) |
|
|
|
10,186 |
|
|
|
-64 |
% |
Income tax provision |
|
|
|
3 |
|
|
|
|
3 |
|
|
|
|
— |
|
|
|
0 |
% |
Net loss |
|
|
$ |
(5,774 |
) |
|
|
$ |
(15,933 |
) |
|
|
$ |
10,186 |
|
|
|
-64 |
% |
(*) - there was no activity for the six months ended June 30, 2024.
Revenue, Cost of Goods Sold and Gross Profit
Revenue increased $0.6 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024, as we commenced commercial sales in July 2024. This was made possible because we obtained an HDE for QUELIMMUNE in February 2024, and final regulatory clearance to sell commercially from the FDA under this HDE in July 2024. The Company has six customer sites for QUELIMMUNE as of June 30, 2025.
Research and Development Expenses
The following table discloses the breakdown of research and development expenses:
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
||||||||
|
|
|
June 30, |
|
|
|
Change |
|
|||||||||||
($ in thousands) |
|
|
2025 |
|
|
|
2024 |
|
|
|
$ |
|
|
% |
|
||||
Clinical trials |
|
$ |
|
1,902 |
|
|
$ |
|
1,938 |
|
|
$ |
|
(36 |
) |
|
|
(2 |
)% |
External services |
|
|
|
151 |
|
|
|
|
654 |
|
|
|
|
(503 |
) |
|
|
(77 |
)% |
Payroll and personnel expenses |
|
|
|
1,229 |
|
|
|
|
1,323 |
|
|
|
|
(94 |
) |
|
|
(7 |
)% |
Other research and development expenses |
|
|
|
186 |
|
|
|
|
116 |
|
|
|
|
70 |
|
|
|
60 |
% |
|
|
$ |
|
3,468 |
|
|
$ |
|
4,031 |
|
|
$ |
|
(563 |
) |
|
|
(14 |
)% |
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.
General and Administrative Expenses
27
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.
Other Expense
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").
Income Tax Provision
We recorded a provision for income taxes of $3 thousand for both the six months ended June 30, 2025, and June 30, 2024.
Net Loss
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.
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 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.
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.
28
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.
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)
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures. Debt financing would also result in fixed payment obligations. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results, and financial condition. See the section titled “Risk Factors” for additional risks associated with our substantial capital requirements.
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.
As of the date of this Quarterly Report, we have neither included nor intend to include any potential cash proceeds from the exercise of our warrants in our short-term or long-term liquidity projections. We will continue to evaluate the probability of warrant exercise over the life of our warrants and the merit of including potential cash proceeds from the exercise in our liquidity projections.
Future Funding Requirements
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:
29
Our estimates of our results of operations, working capital and capital expenditure requirements may be different than our actual needs, and those estimates may need to be revised if, for example, our actual revenue is lower, and our net operating losses are higher, than we project, and our cash and cash equivalents position is reduced faster than anticipated. Until such time, if ever, as we are able to generate significant revenue from the commercialization of our products, we expect to continue financing our operations through the sale of equity, debt, borrowings under credit facilities or through potential collaborations with other companies, other strategic transactions or government or other grants. Adequate capital may not be available to us when needed or on acceptable terms.
Contractual Obligations and Commitments
As of June 30, 2025, the Company does not have any contractual obligations or commitments outstanding. During June 2025, the Company paid down the remaining $0.2 million of outstanding insurance financing obligation that was originally to be paid down through October 2025.
Cash Flows
The following table shows a summary of our cash flows for each of the periods shown below:
|
|
Six Months Ended |
|
|||||
|
|
June 30, |
|
|||||
($ in thousands) |
|
2025 |
|
|
2024 |
|
||
Statement of cash flow data: |
|
|
|
|
|
|
||
Total cash (used in)/provided by: |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(5,661 |
) |
|
$ |
(6,312 |
) |
Investing activities |
|
|
— |
|
|
|
— |
|
Financing activities |
|
|
10,144 |
|
|
|
7,315 |
|
Net increase in cash |
|
$ |
4,483 |
|
|
$ |
1,003 |
|
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.
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.
Critical Accounting Policies and Estimates
The preparation of the unaudited consolidated financial statements and related disclosures in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and income and expenses during the periods reported. Although actual results could materially differ from those estimates, such estimates are developed based on the best information available to management and management's best judgments at the time.
There has been no material change from the policies or methods disclosed in our Annual Report to Form 10-K filed March 27, 2025, and as amended by Form 10-K/A filed April 23, 2025, for the year-ended December 31, 2025.
30
Emerging Growth Company Status
We are an emerging growth company (“EGC”), as defined in the Jumpstart Our Business Startups (“JOBS”) Act. The JOBS Act permits companies with EGC status to take advantage of an extended transition period to comply with new or revised accounting standards, delaying the adoption of these accounting standards until they apply to private companies. We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our consolidated financial statements may not be comparable to companies that comply with the new or revised accounting standards as of public company effective dates.
In addition, we intend to rely on the other exemptions and reduced reporting requirements provided by the JOBS Act. Since we intend to rely on such exemptions, we are not required to, among other things: (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act; (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act; (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the consolidated financial statements (auditor discussion and analysis); and (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation.
We will remain an EGC under the JOBS Act until the earliest of (i) the last day of our first fiscal year following the fifth anniversary of the closing of the Business Combination, (ii) the last date of our fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the date on which we are deemed to be a “large-accelerated filer” under the rules of the SEC with at least $700.0 million of outstanding securities held by non-affiliates, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures.
We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required financial disclosures.
During the fiscal period covered by this report, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act). Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of June 30, 2025, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act are recorded, processed, summarized and reported within the required time periods and are designed to ensure that information required to be disclosed in our reports is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the three months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
31
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
Shareholder Derivative Claims
On July 5, 2024, Forrest A K Wells, a purported stockholder of ours, filed a putative class action complaint in the United States District Court for the District of Colorado, captioned Wells v. SeaStar Medical Holding Corporation, et al., Case No. 1:24-cv-0187 (the “Class Action”). The Class Action alleges that the Company, our Chief Executive Officer, and former Chief Financial Officer made or caused to be made material misstatements or omissions regarding: (a) the projected timing for obtaining FDA approval of our SCD; and (b) our recognition of certain financial instruments, allegedly culminating in our restatement of our consolidated financial statements, disclosed in a Form 8-K and filed on March 27, 2024. The Class Action asserts claims pursuant to the Securities Exchange Act of 1934, including Section 10(b), Rule 10b-5 promulgated thereunder, and Section 20(a). The Class Action seeks to recover, among other remedies, compensatory damages. On March 4, 2025, the Plaintiff filed an amended complaint. On May 5, 2025, the Defendants filed a motion to dismiss the amended complaint. On June 20, 2025, the Plaintiff filed an opposition to the Defendants’ motion to dismiss. The motion to dismiss remains pending before the court.
On December 13, 2024, Jose Lazo, a purported stockholder of ours, filed a putative stockholder derivative action in the United States District Court for the District of Colorado, captioned Lazo v. Schlorff, et. al., Case No. 1:24-cv-3444 (the “Derivative Action”). The factual allegations of the Derivative Action are substantially similar to those of the Class Action. The Derivative Action complaint asserts claims against our Chief Executive Officer, former Chief Financial Officer, and certain members and former members of our Board of Directors for breach of fiduciary duty and claims pursuant to the Securities Exchange Act of 1934, including Section 14(a), Section 10(b), Rule 10b-5 promulgated thereunder, and Section 21D. Among other remedies, the Derivative Action seeks to recover damages and restitution on behalf of us and certain injunctive relief concerning our corporate governance and internal controls. On January 30, 2025, upon joint motion of the parties, the Court stayed the Derivative Action pending the Court’s resolution of the motion to dismiss filed in the Class Action. Additional stockholders may file substantially similar putative derivative complaints in the future. We will not make separate disclosure of any such complaints unless they are materially different than the Derivative Action.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully consider the factors discussed in the “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and our other public filings, which could materially affect our business, financial condition or future results. No additional risk factors have arisen that have not already been disclosed in our Annual Report on Form 10-K for the year-ended December 31, 2024, filed March 27, 2025, except as set forth below.
There is substantial doubt about our ability to continue as a going concern, and we will need additional financing to execute our business plan, to fund our operations and to continue as a going concern, and, if we are unable to obtain additional financing, may be required to pursue a restructuring of our operations or reorganization proceedings under applicable U.S. bankruptcy or insolvency laws.
Developing medical device products, including conducting preclinical studies and clinical trials, is expensive. We expect our research and development expenses to increase in connection with our ongoing activities, particularly as we advance our clinical programs. As of June 30, 2025, we have positive working capital of $2.6 million while we had negative working capital of $3.0 million on December 31, 2024, respectively. We currently do not have sufficient capital to support our operations and complete our planned regulatory approval process. We will need to secure additional capital to continue our operations, and such funding may not be available on acceptable terms, or at all.
Since inception, we have experienced recurring operating losses and negative cash flows and we expect to continue to generate operating losses and consume significant cash resources for the foreseeable future. There is substantial doubt regarding our ability to continue as a going concern. Our independent registered public accounting firm has expressed in its auditors’ report on our 2024 financial statements, included in our Annual Report on Form 10-K filed on March 27, 2025, an emphasis of matter paragraph relating to our ability to continue as a “going concern,” meaning that our recurring losses from operations and negative cash flows from operations raise substantial doubt regarding our ability to continue as a going concern. We have prepared our financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Our financial statements do not include any adjustment to reflect the possible future effects on the
32
recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty, with the exception that all borrowings are classified as current on the balance sheets.
Even if we receive sufficient capital in the future, we will be required to raise additional funds to support our operations and complete our planned regulatory approval process, and such funding may not be available in sufficient amounts or on acceptable terms to us, or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to:
If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we will be prevented from pursuing development and commercialization efforts, including completing the clinical trials and regulatory approval process for our SCD product candidates, which would have a material adverse impact on our business, results of operations and financial condition.
In the event we pursue a restructuring or reorganization under applicable law, we will be subject to the risks and uncertainties associated with such proceedings.
In the event we seek to pursue a restructuring, or if we file for relief under the United States Bankruptcy Code, either Chapter 7, Chapter 11 or other proceedings, our operations, our ability to develop and execute our business plan and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings, including, among others: our ability to execute, confirm and consummate a plan of reorganization; the high costs of bankruptcy proceedings and related fees; our ability to obtain sufficient financing to allow us to emerge from bankruptcy and execute our business plan post-emergence, and our ability to comply with terms and conditions of that financing; our ability to continue our operations in the ordinary course; our ability to maintain our relationships with our customers, business partners, counterparties, employees and other third parties; our ability to obtain, maintain or renew contracts that are critical to our operations on reasonably acceptable terms and conditions; our ability to attract, motivate and retain key employees; the ability of third parties to use certain limited safe harbor provisions to terminate contracts; and the actions and decisions of our stakeholders and other third parties who have interests in our proceedings that may be inconsistent with our operational and strategic plans. Any delays in our proceedings would increase the risks of our being unable to reorganize our business and emerge from any such proceedings and may increase our costs associated with the process or result in prolonged operational disruption for us. Also, we would need the prior approval of a court for transactions outside the ordinary course of business during the course of any such proceedings, which may limit our ability to respond timely to certain events or take advantage of certain opportunities. Because of the risks and uncertainties associated with any such proceedings, we cannot accurately predict or quantify the ultimate impact of events that could occur during any such proceedings. There can be no guarantees that if we seek available protections, we will emerge from protection as a going concern or that holders of our common stock will receive any recovery.
Proposed legislation in the U.S. Congress, including changes in U.S. tax law, may adversely impact us and the value of our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares.
Changes to U.S. tax laws (which changes may have retroactive application) could adversely affect us or holders of our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares. In recent years, many changes to U.S. federal income tax laws have been proposed and made, and additional changes to U.S. federal income tax laws are likely to continue to occur in the future.
The U.S. Congress is currently considering numerous items of legislation which may be enacted prospectively or with retroactive effect, which legislation could adversely impact our financial performance and the value of our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares. Additionally, states in which we operate or own assets may impose new or increased taxes. If enacted, most of the proposals would be effective for the current or
33
later years. The proposed legislation remains subject to change, and its impact on us and purchasers of our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares is uncertain
On May 22, 2025, the U.S. House of Representatives passed a tax bill, which the Senate Finance Committee subsequently modified and released on June 16, 2025, that, if enacted into law in its current form, may affect the U.S. federal income tax considerations applicable to certain non-U.S. investors in our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares. In particular, the bill proposes to add new Section 899 to the Code, which could significantly increase the aggregate tax liability of certain non-U.S. investors with respect to their investment in our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares. The likelihood of the bill or other similar legislation being enacted is uncertain, and the provisions of the bill or other similar legislation may change prior to enactment. Non-U.S. investors are urged to consult their tax advisors regarding the potential application of proposed Section 899 of the Code with respect to their investment in our shares of Common Stock, Pre-Funded Warrants, Warrants and Warrant Shares.
Our Common Stock may be delisted from Nasdaq if we do not maintain compliance with Nasdaq’s continued listing requirements. If our Common Stock is delisted, it could negatively impact us.
Continued listing of a security on Nasdaq is conditioned upon compliance with various continued listing standards. There can be no assurance that we will be able to comply with the applicable listing standards. We have in the past received notifications of noncompliance with Nasdaq’s continued listing standards and there is no guarantee that we will not receive such notifications in the future.
For example, on June 24, 2024, we received a written notification from the Listing Qualifications staff of Nasdaq that we were not in compliance with the requirement to maintain a minimum market value of listed securities of $35 million, as set forth in the MVLS Rule, because the market value of our Securities had been below $35 million for 30 consecutive business days. We had an initial 180 days, or until December 23, 2024, to regain compliance with the MVLS Requirement.
On December 24, 2024, we received the Notification from Nasdaq stating that we had not regained compliance with the Rule. Pursuant to the Notification, the Securities were subject to delisting from Nasdaq on January 3, 2025, unless we requested a hearing before the Panel by December 31, 2024.
We requested a hearing before the Panel by December 31, 2024. As disclosed in a Form 8-K on March 13, 2025, on March 11, 2025, we received a letter from the Panel granting our request to continue listing our Common Stock on Nasdaq, subject to certain conditions. The Panel’s decision provided us with an exception until June 22, 2025, to demonstrate compliance with the Minimum Stockholders’ Equity Requirement (as defined below) for continued listing set forth in Nasdaq Listing Rule 5550(b). The Panel reviewed our compliance plan, which includes the continuation of fundraising efforts that began in 2024 and strategies for achieving long-term compliance with the Stockholders’ Equity Requirement. As part of the conditions outlined in the Panel’s decision, we are required to, on or before June 22, 2025:
On July 1, 2025, we received a letter from Nasdaq confirming that we have regained compliance with Nasdaq’s minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”). Nasdaq noted in its letter that to maintain compliance, we will have to raise additional funds, otherwise we will be below the Minimum Stockholders’ Equity Requirement by the end of July.
Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we will be subject to a Mandatory Panel Monitor until July 1, 2026. If, within that one-year monitoring period, the Nasdaq Listing Qualifications staff (the “Staff”) finds us again out of compliance with the Minimum Stockholders’ Equity Requirement, notwithstanding Nasdaq Listing Rule 5810(c)(2), we would not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and the Staff would not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor would we be afforded an applicable cure or compliance period pursuant to Nasdaq Listing Rule 5810(c)(3).
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Instead, the Staff would issue a “Delist Determination Letter” and we would have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable.
On July 31, 2025, we received a letter from Nasdaq notifying us that we were not in compliance with the $1.00 per share minimum bid price requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2).
This letter had no immediate effect on the listing of the Company’s Common Stock on Nasdaq and we have 180 calendar days from the date of the notice, or until January 27, 2026, to regain compliance with the Bid Price Requirement.
There can be no assurance that we will be able to comply with the Stockholder’s Equity Requirement or Bid Price Requirement, or maintain compliance with other Nasdaq listing requirements. If we fail to regain compliance with Nasdaq’s continued listing standards during any period granted by the Panel, the Securities could be subject to delisting from Nasdaq, unless another exception is granted by Nasdaq.
If our Common Stock ultimately were to be delisted for any reason, it could negatively impact us by (i) reducing the liquidity and market price of our Common Stock; (ii) reducing the number of investors willing to hold or acquire our Common Stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the three months ended June 30, 2025, we did not have sales of unregistered securities not previously included in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities.
N/A
Item 4. Mine Safety Disclosures.
N/A
Item 5. Other Information.
During the three months ended June 30, 2025, no director or officer of the Company
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Item 6. Exhibits
Exhibit Index
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Exhibit |
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Description |
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|
4.1* |
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Form of Pre-Funded Warrant to Purchase Common Stock dated June 20, 2025 |
4.2* |
|
Form of Series A Common Stock Purchase Warrant to Purchase Common Stock dated June 20, 2025 |
4.3* |
|
Form of Series B Common Stock Purchase Warrant to Purchase Common Stock dated June 20, 2025 |
4.4* |
|
Form of Placement Agent Warrant to Purchase Common Stock dated June 20, 2025 |
4.5 |
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Form of Pre-Funded Warrants to Purchase Common Stock (incorporated by reference to Exhibit 4.1 of Form 8-K filed on July 14, 2025) |
4.6 |
|
Form of Common Stock Purchase Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 of Form 8-K filed on July 14, 2025) |
4.7 |
|
Form of Placement Agent Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.3 of Form 8-K filed on July 14, 2025) |
4.8 |
|
Form of Common Stock Purchase Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.1 to Form 8-K filed on August 1, 2025) |
4.9 |
|
Form of Placement Agent Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 to Form 8-K filed on August 1, 2025) |
10.1 |
|
Form of Confidential Bonus Agreement (incorporated by reference to Exhibit 10.1 of Form 8-K filed on June 11, 2025). |
10.2* |
|
Form of Securities Purchase Agreement dated June 20, 2025 |
10.3 |
|
Form of Securities Purchase Agreement dated July 10, 2025 (incorporated by reference to Exhibit 10.1 to Form 8-K filed on July 14, 2025) |
10.4 |
|
Form of Securities Purchase Agreement dated July 31, 2025 (incorporated by reference to Exhibit 10.4 to Form 8-K filed on August 1, 2025) |
10.5 |
|
Engagement Agreement, dated May 17, 2024, by and between SeaStar Medical Holding Corporation and H.C. Wainwright & Co., LLC. (incorporated by reference to Exhibit 10.14 of Form S-1/A filed on June 20, 2025). |
10.6 |
|
Amendment to the Engagement Agreement, dated April 1, 2025, by and between SeaStar Medical Holding Corporation and H.C. Wainwright & Co., LLC. (incorporated by reference to Exhibit 10.15 of Form S-1/A filed on June 20, 2025). |
10.7*+ |
|
Amended and Restated SeaStar Medical Holding Corporation 2022 Omnibus Incentive Plan |
31.1* |
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2* |
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1* |
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2* |
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith
+ Indicates management contract or compensatory plan or arrangement.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
SeaStar Medical Holding Corporation |
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|
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|
|
Date: August 13, 2025 |
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By: |
/s/ Eric Schlorff |
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|
|
Eric Schlorff |
|
|
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Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
Date: August 13, 2025 |
|
By: |
/s/ David Green |
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|
|
David Green |
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Chief Financial Officer (Principal Financial and Accounting Officer) |
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Source:
