[10-Q] ProKidney Corp. Quarterly Earnings Report
ProKidney Corp. reported a substantial operating loss as it advances its lead autologous cell therapy, rilparencel, through late-stage trials while funding clinical and manufacturing operations. For the six months ended June 30, 2025 the consolidated net loss before noncontrolling interest was $74.9 million, cash and cash equivalents were $84.9 million and marketable securities totaled $209.8 million, giving combined short-term liquidity of about $294.7 million. Total assets were $372.1 million and stockholders' deficit was $1.0025 billion, reflecting a large redeemable noncontrolling interest of $1.342 billion.
The company is progressing Phase 3 PROACT 1 to support accelerated approval of rilparencel: the FDA agreed that eGFR slope can serve as a surrogate endpoint for an accelerated BLA and specified an acceptable effect size of at least 1.5 mL/min/1.73m2/year. ProKidney completed the REGEN-007 Phase 2 trial showing in one dosing arm a statistically significant improvement in annual eGFR slope of 4.6 mL/min/1.73m2/year (p<0.001). The company has enrolled nearly half the patients required for the accelerated approval analysis, with topline eGFR slope readout anticipated in Q2 2027.
ProKidney Corp. ha registrato una significativa perdita operativa mentre porta avanti la sua principale terapia cellulare autologa, rilparencel, verso studi di fase avanzata e finanzia le attivit脿 cliniche e produttive. Per i sei mesi chiusi al 30 giugno 2025 la perdita netta consolidata prima della quota di terzi 猫 stata di $74.9 million, la liquidit脿 e le disponibilit脿 liquide erano di $84.9 million e i titoli negoziabili ammontavano a $209.8 million, per una liquidit脿 a breve termine complessiva di circa $294.7 million. Le attivit脿 totali erano pari a $372.1 million e il patrimonio netto degli azionisti mostrava un disavanzo di $1.0025 billion, riflettendo una consistente redeemable noncontrolling interest of $1.342 billion.
L鈥檃zienda sta portando avanti il programma di Fase 3 PROACT 1 per supportare un鈥檃pprovazione accelerata di rilparencel: la FDA ha concordato che la eGFR slope pu貌 fungere da endpoint surrogato per una BLA accelerata e ha specificato un effetto minimo accettabile di almeno 1.5 mL/min/1.73m2/year. ProKidney ha completato lo studio di Fase 2 REGEN-007, che ha mostrato in un braccio di dosaggio un miglioramento statisticamente significativo nella pendenza annuale dell鈥檈GFR di 4.6 mL/min/1.73m2/year (p<0.001). L鈥檃zienda ha arruolato quasi la met脿 dei pazienti necessari per l鈥檃nalisi di approvazione accelerata, con la lettura dei risultati principali sulla pendenza dell鈥檈GFR prevista per il Q2 2027.
ProKidney Corp. registr贸 una p茅rdida operativa sustancial mientras avanza su terapia celular aut贸loga principal, rilparencel, en ensayos de fases avanzadas y financia las operaciones cl铆nicas y de manufactura. Para los seis meses terminados el 30 de junio de 2025, la p茅rdida neta consolidada antes de la participaci贸n minoritaria fue de $74.9 million, el efectivo y equivalentes de efectivo eran $84.9 million y los valores negociables sumaban $209.8 million, dando una liquidez a corto plazo combinada de aproximadamente $294.7 million. Los activos totales eran $372.1 million y el d茅ficit de los accionistas era de $1.0025 billion, reflejando una importante redeemable noncontrolling interest of $1.342 billion.
La compa帽铆a est谩 avanzando el ensayo de Fase 3 PROACT 1 para respaldar una aprobaci贸n acelerada de rilparencel: la FDA acord贸 que la eGFR slope puede servir como punto final sustituto para una BLA acelerada y especific贸 un tama帽o de efecto aceptable de al menos 1.5 mL/min/1.73m2/year. ProKidney complet贸 el ensayo de Fase 2 REGEN-007 mostrando en un brazo de dosificaci贸n una mejora estad铆sticamente significativa en la pendiente anual de eGFR de 4.6 mL/min/1.73m2/year (p<0.001). La compa帽铆a ha inscrito casi la mitad de los pacientes necesarios para el an谩lisis de aprobaci贸n acelerada, con la lectura principal de la pendiente de eGFR prevista para el Q2 2027.
ProKidney Corp.電� 欤茧牓 鞛愱皜靹疙彫旃橂鞝� rilparencel鞚� 頉勱赴 鞛勳儊鞁滍棙鞙茧 歆勴枆頃橂┐靹� 鞛勳儊 氚� 鞝滌“ 鞖挫榿 鞛愱笀鞚� 韴瀰頃� 瓴瓣臣 靸侂嫻頃� 鞓侅梾靻愳嫟鞚� 旮半頄堨姷雼堧嫟. 2025雲� 6鞗� 30鞚茧 膦呺霅� 6臧滌洈 霃欖晥 牍勳氚办攵� 鞚挫爠鞚� 鞐瓣舶 靾滌啇鞁れ潃 $74.9 million鞓�瓿�, 順勱笀 氚� 順勱笀靹膘瀽靷办潃 $84.9 million, 鞁滌灔靹� 鞙犼皜歃濌秾鞚� $209.8 million鞙茧 雼赴 鞙犽彊靹� 頃╆硠電� 鞎� $294.7 million鞐� 雼枅鞀惦媹雼�. 齑濎瀽靷办潃 $372.1 million鞚措┌, 欤检＜歆�攵勳潃 $1.0025 billion鞚� 鞝侅瀽毳� 氤挫榾瓿� 鞚措姅 redeemable noncontrolling interest of $1.342 billion霛茧姅 韥� 頃鞚� 氚橃榿頃╇媹雼�.
須岇偓電� rilparencel鞚� 臧�靻� 鞀轨澑 歆�鞗愳潉 鞙勴暣 3靸� PROACT 1鞚� 歆勴枆 欷戩澊氅�, FDA電� eGFR slope臧� 臧�靻� BLA鞚� 雽�毽弶臧�氤�靾�(surrogate endpoint)搿� 靷毄霅� 靾� 鞛堨潓鞚� 頃╈潣頄堦碃 斓滌唽 項堨毄 須臣 韥赴毳� 1.5 mL/min/1.73m2/year 鞚挫儊鞙茧 氇呾嫓頄堨姷雼堧嫟. ProKidney電� REGEN-007 2靸� 鞁滍棙鞚� 鞕勲頄堨溂氅�, 頃� 韴棳甑办棎靹� 鞐瓣皠 eGFR 旮办毟旮办棎靹� 韱店硠鞝侅溂搿� 鞙犾潣頃� 臧滌劆 4.6 mL/min/1.73m2/year鞚� 氤挫榾鞀惦媹雼� (p<0.001). 須岇偓電� 臧�靻� 鞀轨澑 攵勳劃鞐� 頃勳殧頃� 頇橃瀽鞚� 瓯办潣 鞝堧皹鞚� 霌彪頄堨溂氅�, 欤检殧 eGFR 旮办毟旮� 瓴瓣臣電� Q2 2027鞐� 雮橃槵 瓴冹溂搿� 鞓堨儊霅╇媹雼�.
ProKidney Corp. a enregistr茅 une perte d'exploitation importante alors qu'elle fait progresser sa th茅rapie cellulaire autologue principale, rilparencel, en essais de phase avanc茅e tout en finan莽ant les op茅rations cliniques et de fabrication. Pour les six mois clos le 30 juin 2025, la perte nette consolid茅e avant la participation minoritaire s'est 茅lev茅e 脿 $74.9 million, la tr茅sorerie et 茅quivalents de tr茅sorerie 茅taient de $84.9 million et les titres n茅gociables totalisaient $209.8 million, offrant une liquidit茅 脿 court terme combin茅e d'environ $294.7 million. L'actif total s'茅levait 脿 $372.1 million et les capitaux propres des actionnaires affichaient un d茅ficit de $1.0025 billion, refl茅tant une importante redeemable noncontrolling interest of $1.342 billion.
La soci茅t茅 poursuit la Phase 3 PROACT 1 pour soutenir une autorisation acc茅l茅r茅e de rilparencel : la FDA a convenu que la eGFR slope peut servir d'endpoint substitut pour un BLA acc茅l茅r茅 et a pr茅cis茅 une taille d'effet acceptable d'au moins 1.5 mL/min/1.73m2/year. ProKidney a achev茅 l'essai de Phase 2 REGEN-007 montrant, dans un bras posologique, une am茅lioration statistiquement significative de la pente annuelle de l'eGFR de 4.6 mL/min/1.73m2/year (p<0.001). La soci茅t茅 a recrut茅 pr猫s de la moiti茅 des patients requis pour l'analyse d'approbation acc茅l茅r茅e, la lecture principale de la pente de l'eGFR 茅tant pr茅vue au Q2 2027.
ProKidney Corp. meldete einen erheblichen Betriebsverlust, w盲hrend es seine f眉hrende autologe Zelltherapie rilparencel in sp盲te Studienphasen vorantreibt und klinische sowie Herstellungsaktivit盲ten finanziert. F眉r die sechs Monate zum 30. Juni 2025 betrug der konsolidierte Nettoverlust vor nicht beherrschenden Anteilen $74.9 million, Zahlungsmittel und Zahlungsmittel盲quivalente beliefen sich auf $84.9 million und marktf盲hige Wertpapiere auf $209.8 million, womit die kurzfristig verf眉gbare Liquidit盲t insgesamt etwa $294.7 million betrug. Die Gesamtaktiva lagen bei $372.1 million und das Eigenkapital der Aktion盲re wies ein Defizit von $1.0025 billion auf, was eine gro脽e redeemable noncontrolling interest of $1.342 billion widerspiegelt.
Das Unternehmen treibt die Phase-3-Studie PROACT 1 voran, um eine beschleunigte Zulassung von rilparencel zu unterst眉tzen: Die FDA stimmte zu, dass die eGFR slope als Surrogatendpunkt f眉r eine beschleunigte BLA dienen kann und legte eine akzeptable Effektgr枚脽e von mindestens 1.5 mL/min/1.73m2/year fest. ProKidney schloss die REGEN-007 Phase-2-Studie ab, die in einem Behandlungsarm eine statistisch signifikante Verbesserung der j盲hrlichen eGFR-Steigung von 4.6 mL/min/1.73m2/year zeigte (p<0.001). Das Unternehmen hat fast die H盲lfte der f眉r die Analyse zur beschleunigten Zulassung erforderlichen Patienten rekrutiert; das Topline-Resultat zur eGFR-Steigung wird f眉r Q2 2027 erwartet.
- FDA confirmation that eGFR slope can serve as a surrogate endpoint for accelerated BLA filing for rilparencel, with an acceptable effect size of 鈮�1.5 mL/min/1.73m2/year.
- REGEN-007 Phase 2 Group 1 demonstrated a statistically significant improvement in annual eGFR slope of 4.6 mL/min/1.73m2/year (p<0.001).
- Enrollment progress: nearly half of patients required for the accelerated approval analysis in PROACT 1 have been enrolled.
- Substantial short-term liquidity: combined cash and marketable securities of approximately $294.7 million as of June 30, 2025.
- Large operating losses: net loss before noncontrolling interest of $74.9 million for the six months ended June 30, 2025.
- Cash burn: net cash used in operating activities was $61.0 million for the six months ended June 30, 2025, reducing cash from $99.1M to $84.9M.
- Material capital structure challenges: redeemable noncontrolling interest of $1.342 billion and a stockholders' deficit of $1.0025 billion as of June 30, 2025.
- High ongoing R&D expense: R&D expense was $53.1 million for the six months ended June 30, 2025, reflecting heavy clinical and development costs.
Insights
TL;DR: Clinical progress contrasts with a heavy deficit and ongoing cash burn; liquidity sufficient near-term but balance sheet risks remain.
ProKidney shows meaningful clinical momentum鈥擣DA acceptance of eGFR slope and statistically significant Phase 2 signal鈥攂ut is reporting sizable operating losses ($74.9M six months) and cash used in operations of $61.0M over six months. Combined cash and marketable securities (~$294.7M) provide runway but the $1.342B redeemable noncontrolling interest and >$1.0B stockholders' deficit are material capital structure issues. Investors should note that exchanges tied to PKLP economics and the Tax Receivable Agreement continue to affect equity and potential future cash obligations; these are disclosed and sizable.
TL;DR: FDA endorsement of eGFR slope as a surrogate and a strong Phase 2 efficacy signal materially advance the rilparencel regulatory pathway.
Regulatory feedback is a clear positive: the FDA agreed eGFR slope can be the surrogate endpoint for accelerated approval and specified a target effect size (鈮�1.5 mL/min/1.73m2/year). REGEN-007 Group 1 showed a robust and statistically significant absolute improvement of 4.6 mL/min/1.73m2/year (pre- vs post-injection; p<0.001), supporting the Phase 3 design. Enrollment progress鈥攏early half of patients required for the accelerated approval analysis鈥攕upports feasibility of the planned Q2 2027 topline readout. Clinical risks remain, but these developments are materially positive for the therapy's pathway.
ProKidney Corp. ha registrato una significativa perdita operativa mentre porta avanti la sua principale terapia cellulare autologa, rilparencel, verso studi di fase avanzata e finanzia le attivit脿 cliniche e produttive. Per i sei mesi chiusi al 30 giugno 2025 la perdita netta consolidata prima della quota di terzi 猫 stata di $74.9 million, la liquidit脿 e le disponibilit脿 liquide erano di $84.9 million e i titoli negoziabili ammontavano a $209.8 million, per una liquidit脿 a breve termine complessiva di circa $294.7 million. Le attivit脿 totali erano pari a $372.1 million e il patrimonio netto degli azionisti mostrava un disavanzo di $1.0025 billion, riflettendo una consistente redeemable noncontrolling interest of $1.342 billion.
L鈥檃zienda sta portando avanti il programma di Fase 3 PROACT 1 per supportare un鈥檃pprovazione accelerata di rilparencel: la FDA ha concordato che la eGFR slope pu貌 fungere da endpoint surrogato per una BLA accelerata e ha specificato un effetto minimo accettabile di almeno 1.5 mL/min/1.73m2/year. ProKidney ha completato lo studio di Fase 2 REGEN-007, che ha mostrato in un braccio di dosaggio un miglioramento statisticamente significativo nella pendenza annuale dell鈥檈GFR di 4.6 mL/min/1.73m2/year (p<0.001). L鈥檃zienda ha arruolato quasi la met脿 dei pazienti necessari per l鈥檃nalisi di approvazione accelerata, con la lettura dei risultati principali sulla pendenza dell鈥檈GFR prevista per il Q2 2027.
ProKidney Corp. registr贸 una p茅rdida operativa sustancial mientras avanza su terapia celular aut贸loga principal, rilparencel, en ensayos de fases avanzadas y financia las operaciones cl铆nicas y de manufactura. Para los seis meses terminados el 30 de junio de 2025, la p茅rdida neta consolidada antes de la participaci贸n minoritaria fue de $74.9 million, el efectivo y equivalentes de efectivo eran $84.9 million y los valores negociables sumaban $209.8 million, dando una liquidez a corto plazo combinada de aproximadamente $294.7 million. Los activos totales eran $372.1 million y el d茅ficit de los accionistas era de $1.0025 billion, reflejando una importante redeemable noncontrolling interest of $1.342 billion.
La compa帽铆a est谩 avanzando el ensayo de Fase 3 PROACT 1 para respaldar una aprobaci贸n acelerada de rilparencel: la FDA acord贸 que la eGFR slope puede servir como punto final sustituto para una BLA acelerada y especific贸 un tama帽o de efecto aceptable de al menos 1.5 mL/min/1.73m2/year. ProKidney complet贸 el ensayo de Fase 2 REGEN-007 mostrando en un brazo de dosificaci贸n una mejora estad铆sticamente significativa en la pendiente anual de eGFR de 4.6 mL/min/1.73m2/year (p<0.001). La compa帽铆a ha inscrito casi la mitad de los pacientes necesarios para el an谩lisis de aprobaci贸n acelerada, con la lectura principal de la pendiente de eGFR prevista para el Q2 2027.
ProKidney Corp.電� 欤茧牓 鞛愱皜靹疙彫旃橂鞝� rilparencel鞚� 頉勱赴 鞛勳儊鞁滍棙鞙茧 歆勴枆頃橂┐靹� 鞛勳儊 氚� 鞝滌“ 鞖挫榿 鞛愱笀鞚� 韴瀰頃� 瓴瓣臣 靸侂嫻頃� 鞓侅梾靻愳嫟鞚� 旮半頄堨姷雼堧嫟. 2025雲� 6鞗� 30鞚茧 膦呺霅� 6臧滌洈 霃欖晥 牍勳氚办攵� 鞚挫爠鞚� 鞐瓣舶 靾滌啇鞁れ潃 $74.9 million鞓�瓿�, 順勱笀 氚� 順勱笀靹膘瀽靷办潃 $84.9 million, 鞁滌灔靹� 鞙犼皜歃濌秾鞚� $209.8 million鞙茧 雼赴 鞙犽彊靹� 頃╆硠電� 鞎� $294.7 million鞐� 雼枅鞀惦媹雼�. 齑濎瀽靷办潃 $372.1 million鞚措┌, 欤检＜歆�攵勳潃 $1.0025 billion鞚� 鞝侅瀽毳� 氤挫榾瓿� 鞚措姅 redeemable noncontrolling interest of $1.342 billion霛茧姅 韥� 頃鞚� 氚橃榿頃╇媹雼�.
須岇偓電� rilparencel鞚� 臧�靻� 鞀轨澑 歆�鞗愳潉 鞙勴暣 3靸� PROACT 1鞚� 歆勴枆 欷戩澊氅�, FDA電� eGFR slope臧� 臧�靻� BLA鞚� 雽�毽弶臧�氤�靾�(surrogate endpoint)搿� 靷毄霅� 靾� 鞛堨潓鞚� 頃╈潣頄堦碃 斓滌唽 項堨毄 須臣 韥赴毳� 1.5 mL/min/1.73m2/year 鞚挫儊鞙茧 氇呾嫓頄堨姷雼堧嫟. ProKidney電� REGEN-007 2靸� 鞁滍棙鞚� 鞕勲頄堨溂氅�, 頃� 韴棳甑办棎靹� 鞐瓣皠 eGFR 旮办毟旮办棎靹� 韱店硠鞝侅溂搿� 鞙犾潣頃� 臧滌劆 4.6 mL/min/1.73m2/year鞚� 氤挫榾鞀惦媹雼� (p<0.001). 須岇偓電� 臧�靻� 鞀轨澑 攵勳劃鞐� 頃勳殧頃� 頇橃瀽鞚� 瓯办潣 鞝堧皹鞚� 霌彪頄堨溂氅�, 欤检殧 eGFR 旮办毟旮� 瓴瓣臣電� Q2 2027鞐� 雮橃槵 瓴冹溂搿� 鞓堨儊霅╇媹雼�.
ProKidney Corp. a enregistr茅 une perte d'exploitation importante alors qu'elle fait progresser sa th茅rapie cellulaire autologue principale, rilparencel, en essais de phase avanc茅e tout en finan莽ant les op茅rations cliniques et de fabrication. Pour les six mois clos le 30 juin 2025, la perte nette consolid茅e avant la participation minoritaire s'est 茅lev茅e 脿 $74.9 million, la tr茅sorerie et 茅quivalents de tr茅sorerie 茅taient de $84.9 million et les titres n茅gociables totalisaient $209.8 million, offrant une liquidit茅 脿 court terme combin茅e d'environ $294.7 million. L'actif total s'茅levait 脿 $372.1 million et les capitaux propres des actionnaires affichaient un d茅ficit de $1.0025 billion, refl茅tant une importante redeemable noncontrolling interest of $1.342 billion.
La soci茅t茅 poursuit la Phase 3 PROACT 1 pour soutenir une autorisation acc茅l茅r茅e de rilparencel : la FDA a convenu que la eGFR slope peut servir d'endpoint substitut pour un BLA acc茅l茅r茅 et a pr茅cis茅 une taille d'effet acceptable d'au moins 1.5 mL/min/1.73m2/year. ProKidney a achev茅 l'essai de Phase 2 REGEN-007 montrant, dans un bras posologique, une am茅lioration statistiquement significative de la pente annuelle de l'eGFR de 4.6 mL/min/1.73m2/year (p<0.001). La soci茅t茅 a recrut茅 pr猫s de la moiti茅 des patients requis pour l'analyse d'approbation acc茅l茅r茅e, la lecture principale de la pente de l'eGFR 茅tant pr茅vue au Q2 2027.
ProKidney Corp. meldete einen erheblichen Betriebsverlust, w盲hrend es seine f眉hrende autologe Zelltherapie rilparencel in sp盲te Studienphasen vorantreibt und klinische sowie Herstellungsaktivit盲ten finanziert. F眉r die sechs Monate zum 30. Juni 2025 betrug der konsolidierte Nettoverlust vor nicht beherrschenden Anteilen $74.9 million, Zahlungsmittel und Zahlungsmittel盲quivalente beliefen sich auf $84.9 million und marktf盲hige Wertpapiere auf $209.8 million, womit die kurzfristig verf眉gbare Liquidit盲t insgesamt etwa $294.7 million betrug. Die Gesamtaktiva lagen bei $372.1 million und das Eigenkapital der Aktion盲re wies ein Defizit von $1.0025 billion auf, was eine gro脽e redeemable noncontrolling interest of $1.342 billion widerspiegelt.
Das Unternehmen treibt die Phase-3-Studie PROACT 1 voran, um eine beschleunigte Zulassung von rilparencel zu unterst眉tzen: Die FDA stimmte zu, dass die eGFR slope als Surrogatendpunkt f眉r eine beschleunigte BLA dienen kann und legte eine akzeptable Effektgr枚脽e von mindestens 1.5 mL/min/1.73m2/year fest. ProKidney schloss die REGEN-007 Phase-2-Studie ab, die in einem Behandlungsarm eine statistisch signifikante Verbesserung der j盲hrlichen eGFR-Steigung von 4.6 mL/min/1.73m2/year zeigte (p<0.001). Das Unternehmen hat fast die H盲lfte der f眉r die Analyse zur beschleunigten Zulassung erforderlichen Patienten rekrutiert; das Topline-Resultat zur eGFR-Steigung wird f眉r Q2 2027 erwartet.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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Class of Stock |
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Shares Outstanding as of August 12, 2025 |
Class A common stock, par value $0.0001 per share |
|
|
Class B common stock, par value $0.0001 per share |
|
\`
Table of Contents
|
|
Page |
PART I. |
Financial Information (Unaudited) |
2 |
Item 1. |
Financial Statements |
2 |
|
Condensed Consolidated Balance Sheets |
2 |
|
Condensed Consolidated Statements of Operations |
3 |
|
Condensed Consolidated Statements of Comprehensive Loss |
4 |
|
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit |
5 |
|
Condensed Consolidated Statements of Cash Flows |
9 |
|
Notes to Unaudited Condensed Consolidated Financial Statements |
10 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
26 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
34 |
Item 4. |
Controls and Procedures |
34 |
PART II. |
Other Information |
35 |
Item 1. |
Legal Proceedings |
35 |
Item 1A. |
Risk Factors |
35 |
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 |
35 |
Signatures |
37 |
|
i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements.
ProKidney Corp.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
|
(Unaudited) |
|
|
|
|
||
Assets |
|
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|
|
|
||
Cash and cash equivalents |
$ |
|
|
$ |
|
||
Marketable securities |
|
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|
|
||
Interest receivable |
|
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|
|
||
Prepaid assets |
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||
Prepaid clinical |
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||
Assets held for sale |
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||
Other current assets |
|
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||
Total current assets |
|
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||
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||
Fixed assets, net |
|
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||
Right of use assets, net |
|
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||
Total assets |
$ |
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|
$ |
|
||
|
|
|
|
|
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||
Liabilities and Stockholders' Deficit |
|
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|
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||
Accounts payable |
$ |
|
|
$ |
|
||
Lease liabilities |
|
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|
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||
Accrued expenses and other |
|
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|
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||
Income taxes payable |
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||
Total current liabilities |
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||
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||
Income tax payable, net of current portion |
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||
Lease liabilities, net of current portion |
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||
Total liabilities |
|
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||
Commitments and contingencies |
|
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||
Redeemable noncontrolling interest |
|
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||
|
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|
|
||
Stockholders’ deficit |
|
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||
Class A common stock, $ |
|
|
|
|
|
||
Class B common stock, $ |
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
||
Accumulated other comprehensive gain |
|
|
|
|
|
||
Accumulated deficit |
|
( |
) |
|
|
( |
) |
Total stockholders' deficit |
|
( |
) |
|
|
( |
) |
Total liabilities and stockholders' deficit |
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ProKidney Corp.
Condensed Consolidated Statements of Operations - Unaudited
(in thousands, except for share and per share data)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses |
|
|
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|
||||
Research and development |
|
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|
||||
General and administrative |
|
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|
||||
Total operating expenses |
|
|
|
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|
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|
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|
||||
Operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
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|
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|
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|
||||
Other income (expense): |
|
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|
||||
Interest income |
|
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|
||||
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss before income taxes |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Income tax expense (benefit) |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|||
Net loss before noncontrolling |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss attributable to noncontrolling interest |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss available to Class A common stockholders |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares of Class A common stock outstanding: |
|
|
|
|
|
|
|
|
|
|
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|
||||
Basic and diluted |
|
|
|
|
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|
|
|
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|
||||
Net loss per share attributable to Class A common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ProKidney Corp.
Condensed Consolidated Statements of Comprehensive Loss - Unaudited
(in thousands, except for share and per share data)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Net loss including noncontrolling interest |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized income (loss) on marketable securities |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Other comprehensive income |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
( |
) |
|
Total comprehensive loss including noncontrolling interest |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Less: Total comprehensive loss attributable to noncontrolling interest |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Total comprehensive loss attributable to Class A common stockholders |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit - Unaudited
(in thousands, except for share and per share data)
|
|
For the Three Months Ended June 30, 2025 |
|
||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|||||||||
|
|
|
|
|
|
Class A Common Stock |
|
|
Class B Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
|
Redeemable Noncontrolling Interest |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-in Capital |
|
|
Accumulated Other Comprehensive Loss |
|
|
Accumulated Deficit |
|
|
Total Stockholders' Deficit |
|
|||||||||
Balance as of April 1, 2025 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
Equity-based compensation |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Exchange of Class B common stock for Class A common stock |
|
|
( |
) |
|
|
|
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Impact of equity transactions on redeemable noncontrolling interest |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||
Unrealized income on marketable securities |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
( |
) |
Net loss |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Balance as of June 30, 2025 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit - Unaudited
(in thousands, except for share and per share data)
|
|
|
|
|
|
For The Three Months Ended June 30, 2024 |
|
||||||||||||||||||||||||||||||
|
|
|
|
|
|
Class A Common Stock |
|
|
Class B Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
|
Redeemable Noncontrolling Interest |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-in Capital |
|
|
Accumulated Other Comprehensive Loss |
|
|
Accumulated Deficit |
|
|
Total Stockholders' Deficit |
|
|||||||||
Balance as of April 1, 2024 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||||
Equity-based compensation |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Issuance of Class A common stock |
|
|
– |
|
|
|
|
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Exchange of Class B common stock for Class A common stock |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||||
Exercise of stock options |
|
|
– |
|
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Impact of equity transactions on redeemable noncontrolling interest |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
Unrealized loss on marketable securities |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
|
|||
Net loss |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Balance as of June 30, 2024 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit - Unaudited
(in thousands, except for share and per share data)
|
|
For the Six Months Ended June 30, 2025 |
|
||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
Class A Common Stock |
|
|
Class B Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
|
Redeemable Noncontrolling Interest |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-in Capital |
|
|
Accumulated Other Comprehensive Loss |
|
|
Accumulated Deficit |
|
|
Total Stockholders' Deficit |
|
|||||||||
Balance as of January 1, 2025 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
Equity-based compensation |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Exchange of Class B common stock for Class A common stock |
|
|
( |
) |
|
|
|
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Impact of equity transactions on redeemable noncontrolling interest |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||
Unrealized loss on marketable securities |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
( |
) |
Net loss |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Balance as of June 30, 2025 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
ProKidney Corp.
Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit - Unaudited
(in thousands, except for share and per share data)
|
|
For The Six Months Ended June 30, 2024 |
|
||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
Class A Common Stock |
|
|
Class B Common Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
|
Redeemable Noncontrolling Interest |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Additional Paid-in Capital |
|
|
Accumulated Other Comprehensive Loss |
|
|
Accumulated Deficit |
|
|
Total Stockholders' Deficit |
|
|||||||||
Balance as of January 1, 2024 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|||||||
Equity-based compensation |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|||
Issuance of Class A common stock |
|
|
– |
|
|
|
|
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||||
Vesting of Class B restricted stock rights |
|
|
– |
|
|
|
|
– |
|
|
|
– |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Exchange of Class B common stock for Class A common stock |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
– |
|
|
|
– |
|
|
|
|
||||
Exercise of stock options |
|
|
– |
|
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
Impact of equity transactions on redeemable noncontrolling interest |
|
|
|
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
Unrealized loss on marketable securities |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
– |
|
|
|
( |
) |
Net loss |
|
|
( |
) |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
( |
) |
|
|
( |
) |
Balance as of June 30, 2024 |
|
$ |
|
|
|
|
|
|
$ |
|
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
ProKidney Corp.
Condensed Consolidated Statements of Cash Flows – Unaudited
(in thousands)
|
|
Six Months Ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Cash flows from operating activities |
|
|
|
|
|
|
||
Net loss before noncontrolling interest |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss before noncontrolling interest to net cash flows used |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Equity-based compensation |
|
|
|
|
|
|
||
Gain on marketable securities, net |
|
|
( |
) |
|
|
( |
) |
Loss on lease disposition |
|
|
|
|
|
|
||
Loss on disposal of equipment |
|
|
|
|
|
|
||
Changes in operating assets and liabilities |
|
|
|
|
|
|
||
Interest receivable |
|
|
|
|
|
( |
) |
|
Prepaid and other assets |
|
|
|
|
|
( |
) |
|
Accounts payable and accrued expenses |
|
|
( |
) |
|
|
( |
) |
Income taxes payable |
|
|
( |
) |
|
|
|
|
Net cash flows used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities |
|
|
|
|
|
|
||
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
Sales and maturities of marketable securities |
|
|
|
|
|
|
||
Purchase of equipment and facility expansion |
|
|
( |
) |
|
|
( |
) |
Net cash flows provided by investing activities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Cash flows from financing activities |
|
|
|
|
|
|
||
Proceeds from sales of Class A common stock, net of offering costs |
|
|
|
|
|
|
||
Payments on finance leases |
|
|
( |
) |
|
|
( |
) |
Net cash flows (used in) provided by financing activities |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
||
Net change in cash and cash equivalents |
|
|
( |
) |
|
|
|
|
Cash, beginning of period |
|
|
|
|
|
|
||
Cash, end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
||
Right of use assets obtained in exchange for lease obligations |
|
$ |
|
|
$ |
|
||
Exchange of Class B common stock |
|
$ |
|
|
$ |
|
||
Impact of equity transactions and compensation on redeemable noncontrolling interest |
|
$ |
|
|
$ |
|
||
Equipment and facility expansion included in accounts payable and |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
9
ProKidney Corp.
Notes to Unaudited Condensed Consolidated Financial Statements
Note 1: Description of Business and Basis of Presentation
Description of Business
ProKidney Corp. (the “Company” or “ProKidney”) was originally incorporated as Social Capital Suvretta Holdings Corp. III (“SCS”). SCS was a blank check company incorporated as a Cayman Islands exempted company on
On January 18, 2022, SCS executed a definitive business combination agreement (the “Business Combination Agreement”), with ProKidney LP (“PKLP”), a limited partnership under the laws and regulations of Ireland. Pursuant to the terms of the Business Combination Agreement, PKLP became a subsidiary of SCS and was organized in an umbrella partnership corporation (“Up-C”) structure, which would provide potential future tax benefits for SCS when the equity holders ultimately exchanged their pass-through interests for Class A common stock. The business combination between SCS and PKLP (the “Business Combination”) closed (the “Closing”) on July 11, 2022 (the “Closing Date”). Upon consummation of the transaction, SCS changed its name to ProKidney Corp.
The Business Combination was accounted for as a reverse recapitalization transaction between entities under common control, through which PKLP was considered the accounting acquiror and predecessor entity. The Business Combination was reflected as the equivalent of PKLP issuing stock for the net assets of SCS accompanied by a recapitalization with no goodwill or intangible assets recognized.
ProKidney Corp., through its operating subsidiaries, ProKidney, which is incorporated under the Cayman Islands Companies Act (as amended) as an exempted company (“ProKidney-KY”) and ProKidney LLC, a limited liability company under the laws of Delaware (“ProKidney-US”) is focused on the development of rilparencel, which has the potential to preserve kidney function in patients with chronic kidney disease or delay or eliminate the need for dialysis and organ transplantation.
See Note 12 for a discussion of our recent domestication process through which the Company changed its jurisdiction of incorporation from the Cayman Islands to the State of Delaware.
For presentation purposes, unless otherwise noted, “ordinary shares” before the domestication and “common stock” subsequent
to the domestication are referred to herein as common stock (see Note 12).
Principles of Consolidation
ProKidney is a holding company, and its principal asset is a controlling equity interest in PKLP and its wholly-owned operating subsidiaries ProKidney-KY and ProKidney-US. The Company has determined that PKLP is a variable-interest entity for accounting purposes and that ProKidney is the primary beneficiary of PKLP because (through its managing member interest in PKLP and the fact that the senior management of ProKidney is also the senior management of PKLP) it has the power and benefits to direct all of the activities of PKLP, which include those that most significantly impact PKLP’s economic performance. The Company has therefore consolidated PKLP’s results pursuant to Accounting Standards Codification Topic 810, “Consolidation” in its Condensed Consolidated Financial Statements. As of June 30, 2025, various holders own non-voting interests in PKLP, representing a
Note 2: Significant Accounting Policies
Unaudited Interim Financial Statements
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying Condensed Consolidated Balance Sheet as of June 30, 2025, Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024, Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2025 and 2024, Condensed Consolidated Statement
10
of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit for the three and six months ended June 30, 2025 and 2024 and Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024 are unaudited. These unaudited financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements.
The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of June 30, 2025, the results of operations for the three and six months ended June 30, 2025 and 2024 and cash flows for the six months ended June 30, 2025 and 2024. Certain prior year amounts have been reclassified to conform to the current year presentation. The December 31, 2024 Condensed Consolidated Balance Sheet included herein was derived from the audited financial statements but does not include all disclosures or notes required by GAAP for complete financial statements. These financial statements should be read in conjunction with the audited financial statements and the accompanying notes for the year ended December 31, 2024, contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 17, 2025.
Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). These unaudited consolidated financial statements are presented in U.S. Dollars.
Interim results are not necessarily indicative of results for an entire year.
Use of Estimates
The preparation of unaudited condensed consolidated financial statements, in accordance with GAAP, requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the condensed consolidated financial statements, and the amounts of expenses during the reported periods. Certain estimates in these condensed consolidated financial statements have been made in connection with the calculation of research and development expenses, equity-based compensation expense and the provision for or benefit from income taxes. The Company bases its estimates on historical experience and various other assumptions, including in certain circumstances future projections, which management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.
Cash Equivalents and Marketable Securities
The Company considers all highly liquid investments with an original maturity of 90 days or less on the date of purchase to be cash equivalents. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items.
The Company’s investments in marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as short-term due to its availability for use in its current operations. The cost of securities sold is determined using the specific identification method.
The Company considers all available evidence to evaluate if a credit loss exists, and if so, recognizes an allowance for credit loss.
Concentrations of Credit Risk
Cash and equivalents are the primary financial instruments held by the Company that are potentially subject to concentrations of credit risk. The Company’s cash and equivalents are deposited in accounts at large financial institutions, and such amounts may exceed federally insured limits.
11
Accrued Expenses
Accrued expenses as presented in the Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024 consisted of the following (in thousands):
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
Compensation |
$ |
|
|
$ |
|
||
Severance |
|
|
|
|
|
||
Clinical study related costs |
|
|
|
|
|
||
Facility related costs |
|
|
|
|
|
||
Accrued legal costs |
|
|
|
|
|
||
Accrued consulting and professional fees |
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
||
Total accrued expenses and other |
$ |
|
|
$ |
|
||
Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including salaries, benefits, third party license fees, and external costs of outside vendors engaged to conduct manufacturing and preclinical development activities and clinical trials.
The Company records accruals based on estimates of services received, efforts expended, and amounts owed pursuant to contracts with numerous contract research organizations. In the normal course of business, the Company contracts with third parties to perform various clinical study activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variation from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events and the completion of portions of the clinical study or similar conditions. The objective of the Company’s accrual policy is to match the recording of expenses in its financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical studies are recognized based on the company’s estimate of the degree of completion of the event or events specified in the specific clinical study.
The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the Condensed Consolidated Statement of Operations and Comprehensive Loss as the Company receives the related goods or services.
Costs incurred in obtaining technology licenses are charged to research and development expense as purchased in-process research and development if the technology licensed has not reached technological feasibility and has no alternative future use.
Fixed Assets
Fixed assets are stated at cost, less accumulated depreciation. Generally, expenditures for maintenance and repairs are charged to expense and major improvements or replacements are capitalized. The Company computes depreciation and amortization using the straight-line method over the estimated useful life of the asset. Leasehold improvements are amortized over the lesser of the life of the lease or the estimated useful life of the leasehold improvement.
Buildings |
|
Computer equipment and software |
|
Furniture and equipment |
|
Leasehold improvements |
12
Fixed assets consisted of the following (in thousands):
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
Land |
$ |
|
|
$ |
|
||
Buildings |
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
||
Furniture and equipment |
|
|
|
|
|
||
Computer equipment and software |
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
||
Less: accumulated depreciation |
|
( |
) |
|
|
( |
) |
Total fixed assets, net |
$ |
|
|
$ |
|
||
Depreciation expense for the three months ended June 30, 2025 and 2024 was $
Impairment of Long-Lived Assets and Assets Held for Sale
Long-lived assets such as fixed assets and intangible assets subject to amortization are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset.
The Company’s real property in Greensboro, North Carolina continues to meet the criteria for held-for-sale accounting. The carrying value of this asset has been reflected as a component of total current assets in the accompanying Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024.
Income Taxes
The Company uses the liability method in accounting for income taxes as required by ASC Topic 740 — Income Taxes, under which deferred tax assets and liabilities are recorded for the future tax consequences attributable to the differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is recorded to reduce the carrying amounts of deferred tax assets unless it is more likely than not that such assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, available taxes in the carryback periods, projected future taxable income and tax planning strategies in making this assessment. Accordingly, the Company has provided a full valuation allowance to offset the net deferred tax assets at June 30, 2025 and December 31, 2024.
Interest and penalties related to income taxes are included in the expense for income taxes in the Company’s Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company has not incurred any significant interest or penalties related to income taxes in any of the periods presented.
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 the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. A three-level fair value hierarchy that prioritizes the inputs used to measure fair value is described below. The three levels of inputs used to measure fair value are as follows:
13
For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures.
The carrying values of cash equivalents, accounts payable, and accrued liabilities approximate fair value due to the short term nature of these instruments.
Leases
The Company determines if an arrangement is a lease at inception. Balances recognized related to the Company’s operating and finance leases are included in right-of-use assets, net and lease liabilities in the Condensed Consolidated Balance Sheets. Right of use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Lease terms may include options to extend or terminate the lease if it is reasonably certain that the Company will exercise the option. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. The right of use asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company has elected a practical expedient to not separate its lease and non-lease components and instead account for them as a single lease component. Leases with a term of 12 months or less are not recorded on the balance sheet.
Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Lease payments for short-term leases are recorded to operating expense on a straight-line basis and variable lease payments are recorded in the period in which the obligation for those payments is incurred.
Contingent Liabilities
The Company records reserves for contingent liabilities when it is probable that an asset has been impaired or a liability has been incurred at the date of the financial statements, and the amount of the loss can be reasonably estimated.
Equity-Based Compensation
Compensation expense for equity-based compensation awards issued is based on the fair value of the award at the date of grant, and compensation expense is recognized for time-vested awards earned over the service period on a straight-line basis. The Company recognizes equity-based compensation for options containing performance-based vesting conditions over the requisite service period if it is probable that the performance conditions will be satisfied. The Company records forfeitures of equity-based compensation awards as they occur.
Segments
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires entities to disclose disaggregated information about their effective tax rate reconciliation and income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply them retrospectively. The standard is effective for annual periods
14
beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the disclosure requirements related to this new standard.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures, which requires disclosure of additional information about specific expense categories in the notes to the financial statements on an interim and annual basis. The standard is effective for fiscal years beginning after December 15, 2026, and for interim periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the disclosure requirements related to this new standard
Note 3: Investments
Cash equivalents and marketable securities are measured at fair value and within Level 2 in the fair value hierarchy, because we use quoted market prices to the extent available or alternative pricing sources and models utilizing market observable inputs to determine fair value.
The following tables summarize our cash equivalents and marketable securities measured at fair value on a recurring basis (in thousands):
As of June 30, 2025 |
|
||||||||||||||||||||||||
|
Fair Value Hierarchy |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Cash Equivalents |
|
|
Marketable Securities |
|
||||||
Money market funds |
Level 2 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Time deposits |
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Commercial paper |
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Asset backed securities |
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Government bonds |
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Corporate debt securities |
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Total |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
As of December 31, 2024 |
|
||||||||||||||||||||||||
|
Fair Value Hierarchy |
|
Amortized Cost |
|
|
Gross Unrealized Gains |
|
|
Gross Unrealized Losses |
|
|
Fair Value |
|
|
Cash Equivalents |
|
|
Marketable Securities |
|
||||||
Money market funds |
Level 2 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Time deposits |
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Commercial paper |
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Asset backed securities |
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Government bonds |
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Corporate debt securities |
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||||
Total |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|||||
The following table shows the fair value of the Company’s cash equivalents and marketable securities, by contractual maturity, as of June 30, 2025 (in thousands):
|
June 30, 2025 |
|
|
Due in 1 year or less |
$ |
|
|
Due in 1 year through 5 years |
|
|
|
Total |
$ |
|
|
The following table shows fair values and gross unrealized losses recorded to accumulated other comprehensive income, aggregated by category and the length of time that individual securities have been in a continuous loss position (in thousands):
15
As of June 30, 2025 |
|
||||||||||||||||||||||
|
Less than 12 months |
|
|
12 Months or Greater |
|
|
Total |
|
|||||||||||||||
|
Fair Value |
|
|
Unrealized Loss |
|
|
Fair Value |
|
|
Unrealized Loss |
|
|
Fair Value |
|
|
Unrealized Loss |
|
||||||
Commercial paper |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
Asset backed securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Government bonds |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Corporate debt securities |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
||||
Total |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
As of December 31, 2024 |
|
||||||||||||||||||||||
|
Less than 12 months |
|
|
12 Months or Greater |
|
|
Total |
|
|||||||||||||||
|
Fair Value |
|
|
Unrealized Loss |
|
|
Fair Value |
|
|
Unrealized Loss |
|
|
Fair Value |
|
|
Unrealized Loss |
|
||||||
Commercial paper |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
Corporate debt securities |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
||||
Total |
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
||||
The Company holds debt securities of companies with high credit quality and has determined that there was no material change in the credit risk of its debt securities during the three and six months ended June 30, 2025 and 2024. As such, the Company has
ProKidney is considered to be an exempted Cayman Islands company and is presently not subject to income taxes or income tax filing requirements in the Cayman Islands or the United States.
The Company’s subsidiary, PKLP, is organized as a limited partnership and is classified as a partnership for U.S. income tax purposes.
The difference between the Company’s effective tax rates and the Cayman statutory rate of
The Company’s subsidiary, ProKidney-KY, has been granted, by the Government in Council of the Cayman Islands, tax concessions under an undertaking certificate exempting it from any tax levied on profits, income, gains or appreciations in relation to its operations or in the nature of estate duty or inheritance tax for a period of twenty years from January 20, 2016. ProKidney-KY elected to be treated as an entity disregarded from its owner for U.S. tax purposes, and as a result, it has not recorded an income tax provision.
As discussed in Note 6, the Company is party to a tax receivable agreement with a related party which provides for the payment by the Company to holders of PKLP prior to the Closing (“Closing ProKidney Unitholders”) of
In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, available taxes in the carryback periods, projected future taxable income and tax planning strategies in making this assessment.
There were
There were no significant changes in the Company’s uncertain tax positions during the three and six months ended June 30, 2025 and 2024.
On July 4, 2025, the One Big Beautiful Bill Act was signed into law. This legislation includes changes to U.S. federal tax law, which may be subject to further clarification and the issuance of interpretive guidance. The Company is assessing the legislation and
16
its effect on its consolidated financial statements, which it expects to begin reflecting in the three month period ended September 30, 2025.
As discussed further in Note 12, the Company completed a domestication process effective July 1, 2025 through which the Company changed its jurisdiction of incorporation from the Cayman Islands to the State of Delaware. The Company does not expect this domestication to have an adverse impact on its tax positions.
Note 5: Leases
The Company has operating leases for real estate (primarily its operating facilities) and certain equipment with various expiration dates. The Company also has finance leases for certain equipment. During the year ended December 31, 2024, the Company purchased two multi-tenant buildings in Winston-Salem, North Carolina, which it had previously occupied under the terms of a real estate lease. In connection with this purchase, the Company assumed the existing lease agreements held with certain third parties which leased space in these buildings.
Lessee Leases
For the three months ended June 30, 2025 and 2024, the Company’s rent expense was $
The following table summarizes the classification of operating and finance lease assets and obligations in the Company's Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024 (in thousands):
|
|
June 30, 2025 |
|
|
December 31, 2024 |
|
||
Operating leases: |
|
|
|
|
|
|
||
Right of use assets |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Operating lease liabilities, current |
|
$ |
|
|
$ |
|
||
Operating lease liabilities, noncurrent |
|
|
|
|
|
|
||
Total operating lease liabilities |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Finance leases: |
|
|
|
|
|
|
||
Right of use assets |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Finance lease liabilities, current |
|
$ |
|
|
$ |
|
||
Finance lease liabilities, noncurrent |
|
|
|
|
|
|
||
Total finance lease liabilities |
|
$ |
|
|
$ |
|
||
Maturities of lease liabilities for the Company’s operating and finance leases are as follows as of June 30, 2025 (in thousands):
|
|
Operating Leases |
|
|
Finance Leases |
|
|
Total |
|
|||
2025 (remaining six months) |
|
$ |
|
|
$ |
|
|
$ |
|
|||
2026 |
|
|
|
|
|
|
|
|
|
|||
2027 |
|
|
|
|
|
|
|
|
|
|||
2028 |
|
|
|
|
|
|
|
|
|
|||
2029 |
|
|
|
|
|
|
|
|
|
|||
Thereafter |
|
|
|
|
|
|
|
|
|
|||
Total lease payments |
|
|
|
|
|
|
|
|
|
|||
Less: imputed interest |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Present value of lease liabilities |
|
$ |
|
|
$ |
|
|
$ |
|
|||
The weighted average remaining lease term for operating leases is
17
Lessor Leases
The Company leases a portion of its facilities in Winston-Salem, North Carolina under agreements that are classified as operating leases. In addition to the rental payments, tenants pay a fixed rate for their pro rata share of real estate taxes, insurance and other facility operating expenses. These amounts are recognized as revenues on a straight-line basis over the term of the related leases. For leasing revenues where collectability is not considered probable, lease income is recognized on a cash basis and all previously recognized tenant accounts receivables, including straight-line rent, are fully reserved in the period in which the lease income is determined not to be probable of collection. These lease agreements terminate between 2026 and 2029.
The leasing revenue for the three and six months ended June 30, 2025 was $
|
|
Total |
|
|
2025 (remaining six months) |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Thereafter |
|
|
|
|
Total |
|
$ |
|
|
Note 6: Related Party Transactions
Exchange Agreement
On the Closing Date, the Company entered into an exchange agreement with PKLP and certain Closing ProKidney Unitholders (the “Exchange Agreement”) pursuant to which, subject to the procedures and restrictions therein, from and after the waiver or expiration of any contractual lock-up period (including pursuant to the Lock-Up Agreement (as defined below)) the holders of Post-Combination ProKidney Common Units as defined in the Exchange Agreement (or certain permitted transferees thereof) have the right from time to time at and after 180 days following the Closing to exchange their Post-Combination ProKidney Common Units and an equal number of shares of Class B common stock of the Company on a one-for-one basis for shares of Class A common stock of the Company (the “Exchange”); provided, that, subject to certain exceptions, the Company, at its sole election, subject to certain restrictions, may, other than in the case of certain secondary offerings, instead settle all or a portion of the Exchange in cash based on a volume weighted average price (“VWAP”) of a share of Class A common stock. The Exchange Agreement provides that, as a general matter, a holder of Post-Combination ProKidney Common Units will not have the right to exchange Post-Combination ProKidney Common Units if the Company determines that such exchange would be prohibited by law or regulation or would violate other agreements with the Company and its subsidiaries to which the holder of Post-Combination ProKidney Common Units may be subject, including the Second Amended and Restated ProKidney Limited Partnership Agreement and the Exchange Agreement.
Lock-Up Agreement
On the Closing Date, the Company, SCS Sponsor III LLC and certain Closing ProKidney Unitholders entered into a lock-up agreement (the “Lock-Up Agreement”). The Lock-Up Agreement contains certain restrictions on transfer with respect to the SCS Sponsor III LLC and the Closing ProKidney Unitholders party thereto. Such restrictions began at the Closing and end on the earlier of (i) the date that is 180 days after the Closing and (ii)(a) for 33% of the Lock-Up Shares (other than the Earnout Shares and the PIPE Shares), the date on which the last reported sale price of the Class A common stock
18
During January 2023, the lock-up period for
Tax Receivable Agreement
On the Closing Date, the Company entered into a tax receivable agreement (the “Tax Receivable Agreement”) with the Closing ProKidney Unitholders. Pursuant to the Tax Receivable Agreement, among other things, the Company will be required to pay the Closing ProKidney Unitholders party thereto
Earnout Rights
At the Closing, certain stockholders were issued an aggregate of
Consulting Services Agreement between ProKidney-KY and Nefro Health
On January 1, 2020, ProKidney-KY (formerly known as inRegen) entered into a consulting services agreement with Nefro Health (“Nefro”), an Irish partnership controlled and majority-owned by Mr. Pablo Legorreta, a director of the Company, ProKidney GP Limited, a private limited company incorporated under the laws of Ireland (“Legacy GP”) and a holder of over 5% of Class A Units in PKLP, pursuant to which Nefro provides consulting services for the research and development of the Company’s product candidates, including the conduct of clinical trials in North America and the European Union, the design and manufacturing of ProKidney’s product candidates as well as pre-commercialization activities, which are primarily performed by Mr. Legorreta. Under the agreement, Nefro receives $
Consulting Services Agreement between ProKidney-US and Nefro Health
On January 1, 2020, ProKidney-US (formerly known as Twin City Bio, LLC) entered into a consulting services agreement with Nefro, pursuant to which Nefro provides consulting services for the research and development of the Company’s product candidates, including the conduct of clinical trials in North America and the European Union, the design and manufacturing of the Company’s product candidates as well as pre-commercialization activities, which are primarily performed by Mr. Legorreta. Under the agreement, Nefro receives $
19
Note 7: Redeemable Noncontrolling Interest
The Company is subject to the Exchange Agreement with respect to the Post-Combination ProKidney Common Units representing the outstanding
The redeemable noncontrolling interest is recognized at the higher of (1) its initial fair value plus accumulated earnings/losses associated with the noncontrolling interest or (2) the redemption value as of the balance sheet date. At June 30, 2025, the redeemable noncontrolling interest was recorded based on its initial fair value plus accumulated losses associated with the noncontrolling interest which was higher than the redemption value as of the balance sheet date.
Changes in the Company’s ownership interest in PKLP while the Company retains its controlling interest in PKLP are accounted for as equity transactions, and the Company is required to adjust noncontrolling interest and equity for such changes.
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Net loss available to Class A common stockholders |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
(Increase)/Decrease in ProKidney Corp. accumulated deficit for impact of |
|
|
|
|
|
|
|
|
|
|
|
||||
(Increase)/Decrease in ProKidney Corp. additional paid-in capital for exchange |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
(Increase)/Decrease in ProKidney Corp. additional paid-in capital for vesting of |
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
||
Change from net loss available to Class A common stockholders and change |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Note 8: Stockholders’ Equity
In January 2024, the Company entered into an Open Market Sale AgreementSM (the “2024 Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which the Company may offer and sell, from time to time, through Jefferies, shares of its Class A common stock having an aggregate offering price of up to $
On July 14, 2025, the Company terminated the 2024 Sales Agreement with Jefferies and entered into an new Open Market Sales AgreementSM (the “2025 Sales Agreement”) with Jefferies, pursuant to which the Company may offer and sell, from time to time, shares (the “Shares”) of its Class A common stock having an aggregate offering price of up to $
Pursuant to the 2025 Sales Agreement, sales of the Shares may be made by any method permitted that is deemed to be an “at the market” offering as defined in Rule 415(a)(4) under the Securities Act, in ordinary brokers’ transactions, to or through a market maker, on or through The Nasdaq Capital Market or any other market venue where the securities may be traded, in the over-the-counter market, in privately negotiated transactions or through a combination of any such methods of sale. Under the 2025 Sales Agreement, Jefferies will be entitled to compensation of up to
20
During the three and six months ended June 30, 2024, the Company sold
In June 2024, the Company sold
Note 9: Net Loss per Share
Basic net loss per share is calculated by dividing net loss attributable to Class A common stockholders by the weighted-average shares of the Class A common stock outstanding without the consideration for potential dilutive securities. Diluted net loss per share represents basic net loss per share adjusted to include the effects of all potentially dilutive shares. Diluted net loss per share is the same as basic loss per share for all periods as the inclusion of potentially issuable shares would be antidilutive.
The following table sets forth the computation of basic and diluted net loss per share for the three months ended June 30, 2025 and 2024 (in thousands, except share and per share amounts):
|
Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Numerator |
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Less: Net loss attributable to noncontrolling interests |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Net loss available to Class A common stockholders of ProKidney Corp., |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Denominator |
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares of Class A common stock of ProKidney Corp. outstanding, |
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to Class A common stock |
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share attributable to Class A common stock of ProKidney Corp., basic and diluted |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Outstanding anti-dilutive securities not included in the diluted net loss per share calculation include the following:
|
As of June 30, |
|
|||||
|
2025 |
|
|
2024 |
|
||
Antidilutive securities |
|
|
|
|
|
||
ProKidney Corp. Class B common stock |
|
|
|
|
|
||
Unvested Restricted Stock Rights |
|
|
|
|
|
||
Earnout Rights |
|
|
|
|
|
||
Stock options granted under the 2022 Equity Incentive Plan |
|
|
|
|
|
||
Note 10: Equity-Based Compensation
2022 Incentive Equity Plan
On July 11, 2022, the stockholders of the Company approved the ProKidney Corp. 2022 Incentive Equity Plan (the “2022 Plan”) which provides for the issuance of equity-based awards to the Company’s employees, non-employee directors, individual consultants, advisors and other service providers. The 2022 Plan provides for the issuance of equity awards in the form of incentive
21
stock options, which are intended to satisfy the requirements of Section 422 of the Internal Revenue Code of 1986, as amended, or nonqualified stock options, which are not intended to meet those requirements, stock appreciation rights, restricted stock, restricted stock units, performance awards or other cash or stock-based awards as determined appropriate by the plan administrator. In settlement of its obligations under this plan, the Company will issue new shares of Class A common stock.
The Company has issued incentive and non-qualified stock option awards under the 2022 Plan to certain employees, individual consultants and non-employee directors of the Company. Given that the Company has established a full valuation allowance against its deferred tax assets, the Company has recognized no tax benefit related to these awards.
Time-Vested Awards
The Company uses the Black-Scholes option pricing model to calculate the fair value of time-vested stock options granted. These awards generally vest ratably over a three or four-year period and the option awards expire after a term of ten years from the date of grant.
|
|
Six Months Ended June 30, |
||
|
|
2025 |
|
2024 |
Expected volatility |
|
|
||
Expected life of options, in years |
|
|
||
Risk-free interest rate |
|
|
||
Expected dividend yield |
|
|
||
The following table summarizes the activity related to the Company’s time-vested stock option awards granted under the 2022 Plan for the six months ended June 30, 2025:
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
||
Time-vested options outstanding at January 1, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
Time-vested options outstanding at June 30, 2025 |
|
|
|
|
$ |
|
||
Time-vested options exercisable at June 30, 2025 |
|
|
|
|
$ |
|
||
Weighted average remaining contractual life |
|
|
|
|
|
|||
Time-vested options vested and expected to vest at June 30, 2025 |
|
|
|
|
$ |
|
||
Weighted average remaining contractual life |
|
|
|
|
|
|||
As of June 30, 2025, the Company had total unrecognized stock-based compensation expense of approximately $
The aggregate intrinsic value of the in-the-money time-vested awards outstanding and those exercisable as of June 30, 2025 was $
22
Performance-Based Awards
The Company has issued stock options to certain of its employees which vest based on the achievement of both operational performance metrics and service rendered over a specific time period.
|
|
Number of Shares |
|
|
Weighted Average Exercise Price |
|
||
Performance-based options outstanding at January 1, 2025 |
|
|
|
|
$ |
|
||
Forfeited |
|
|
( |
) |
|
|
|
|
Performance-based options outstanding at June 30, 2025 |
|
|
|
|
$ |
|
||
Performance-based options exercisable at June 30, 2025 |
|
|
|
|
$ |
|
||
Weighted average remaining contractual life |
|
|
|
|
|
|||
Performance-based options vested and expected to vest at June 30, 2025 |
|
|
|
|
$ |
|
||
Weighted average remaining contractual life |
|
|
|
|
|
|||
As of June 30, 2025, the Company had no remaining unrecognized stock-based compensation expense related to its performance-based awards.
Legacy Profits Interests
The Deed for the Establishment of a Limited Partnership of PKLP, dated as of August 5, 2021 (the “Limited Partnership Agreement”) which replaced the Amended and Restated Limited Liability Company Agreement of ProKidney LLC as the governing document of the parent entity in the Company, allowed for the issuance of Profits Interests (as defined in the Limited Partnership Agreement) to employees, directors, other service providers of the Company and others denominated in the form of one or more Class B Units of PKLP (as defined in the Limited Partnership Agreement).
Under the Limited Partnership Agreement, Legacy GP determined the terms and conditions of the Profits Interests issued. The threshold value assigned to each grant was not to be less than the fair market value of PKLP on the date of grant.
On January 17, 2022, PKLP amended and restated its Limited Partnership Agreement (the “Amended and Restated Limited Partnership Agreement”) which provided that certain qualified distribution events would result in holders of Profits Interests receiving disproportionate distributions from PKLP until each such holder’s valuation threshold had been reduced to zero in order to “catch up” such holder’s distributions to its pro rata share of aggregate cumulative distributions, and once sufficient distributions to a holder of Profits Interests had been made in accordance with the foregoing, the associated Class B Units of PKLP would automatically be converted into Class A Units of PKLP (as defined in the Limited Partnership Agreement).
Upon consummation of the Business Combination discussed in Note 1, PKLP’s existing Class B and B-1 Units were “caught up” and were converted into Class A Units of PKLP. The resulting vested and unvested Class A Units of PKLP were then recapitalized into Post-Combination ProKidney Common Units or Restricted Common Units of the Company, respectively. This recapitalization resulted in a decrease in the number of awards held by each participant. As such, the number of Profits Interests and related per unit values within these financial statements have been adjusted to reflect this recapitalization. Upon recapitalization, the Restricted Common Units maintained the vesting schedules associated with the original Profits Interest awards.
The following table summarizes the activity related to the Profits Interest awards for the six months ended June 30, 2025:
|
|
Number of Shares |
|
|
Weighted Average Grant Date Fair Value |
|
||
Unvested awards outstanding at January 1, 2025 |
|
|
|
|
$ |
|
||
Vested |
|
|
( |
) |
|
|
|
|
Forfeited |
|
|
( |
) |
|
|
|
|
Unvested awards outstanding at June 30, 2025 |
|
|
|
|
$ |
|
||
23
As of June 30, 2025, the unrecognized compensation expense related to these awards was $
The aggregate intrinsic value of the unvested profits interests outstanding at June 30, 2025 was $
Equity-Based Compensation Expense
Compensation expense related to equity-based awards is included in research and development and general and administrative expense as follows (in thousands):
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Research and development |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
||||
Total equity-based compensation expense |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The following table summarizes our equity-based compensation by type of award (in thousands):
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Time-vested stock options |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Performance-based stock options |
|
|
|
|
|
|
|
|
|
|
|
||||
Legacy profits interests |
|
|
|
|
|
|
|
|
|
|
|
||||
Total equity-based compensation expense |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Note 11: Segment Information
We regularly review our operating segments and the approach used by management to evaluate performance and allocate resources. We manage our business as a single operating segment. The Company’s Chief Executive Officer is considered to be the Company’s chief operating decision maker under the requirements of Topic 280 of the ASC “Segments”. The primary measure of profit/loss reviewed by the chief operating decision maker (“CODM”) is net loss before noncontrolling interest.
The Company does not have any product candidates approved for sale and has not generated any revenue from product sales. The Company recognizes lease revenue related to lease agreements held with certain third parties which leased space in the buildings which also house the Company’s manufacturing operations.
We manage our assets on a total company basis, not by operating segment. Therefore, our CODM does not regularly review any asset information other than total Company assets. See the Company’s Condensed Consolidated Balance Sheets for total assets. The majority of the Company’s long-lived assets are located in the United States.
The following table provides selected income statement information for our single reportable segment (in thousands):
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Net loss before noncontrolling interest |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Rental income |
|
|
|
|
|
|
|
|
|
|
|
||||
Depreciation and amortization |
|
|
|
|
|
|
|
|
|
|
|
||||
Equity-based compensation |
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax (benefit) expense |
|
|
|
|
( |
) |
|
|
|
|
|
|
|||
Interest expense |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest income |
|
|
|
|
|
|
|
|
|
|
|
||||
24
The following table provides significant expense categories that are regularly reported to the CODM (in thousands):
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Revenue |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
Clinical trial expense |
|
|
|
|
|
|
|
|
|
|
|
||||
Cash compensation |
|
|
|
|
|
|
|
|
|
|
|
||||
Cash operating expenses |
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment items (1) |
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss before noncontrolling interest |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Note 12: Subsequent Events
Domestication
Effective July 1, 2025 (the “Domestication Date”), the Company completed a domestication process through which it changed its jurisdiction of incorporation from the Cayman Islands to the State of Delaware (the “Domestication”). In connection with the Domestication, the Company also completed certain other restructuring transactions (such transactions, together with the Domestication, the “Restructuring”) on the Domestication Date. Prior to the Restructuring, ProKidney Corp. conducted its business indirectly through PKLP and its subsidiaries. As part of the Restructuring, (i) PKLP contributed substantially all of its assets to a newly formed subsidiary, ProKidney Holdings, LLC, a Delaware limited liability company (“ProKidney Holdings”) (other than its limited liability company interests in ProKidney Holdings), (ii) PKLP commenced winding-up and made a liquidating distribution of its limited liability company interests in ProKidney Holdings to its partners, including ProKidney Corp., in redemption of their interests in PKLP, and (iii) ProKidney Corp. GP Limited, the general partner of PKLP, sold its nominal economic interest in ProKidney Holdings received in such liquidating distribution to ProKidney Corp. (collectively, the “Substitution”). Immediately following the Domestication, ProKidney-KY, then a wholly owned subsidiary of ProKidney Holdings and a Cayman Islands exempted company, re-registered as a Cayman Islands limited liability company and then deregistered as a limited liability company in the Cayman Islands and registered by way of continuation out for purposes of the Limited Liability Companies Act (as amended) of the Cayman Islands and domesticated and continued for purposes of the Delaware Limited Liability Company Act as a Delaware limited liability company named ProKidney IPCo, LLC (“ProKidney IPCo”). As a result of the consummation of the Domestication and the other transactions involved in the Restructuring, the Company and the other former limited partners of PKLP are now members of ProKidney Holdings, and ProKidney Holdings owns all of the subsidiaries that conduct the Company’s business, including ProKidney IPCo.
In connection with the Domestication and the other Restructuring transactions, the Company amended and restated certain of its material agreements, each originally dated July 11, 2022, on substantially similar terms in order to reflect updates to the Company’s corporate structure resulting from the Restructuring including (i) an Amended and Restated Tax Receivable Agreement, (ii) an Amended and Restated Lock-Up Agreement, and (iii) an Amended and Restated Exchange Agreement. In addition, on the Domestication Date, the Company, together with the other former limited partners of PKLP, also entered into the Second Amended and Restated Limited Liability Company Agreement of ProKidney Holdings to provide for the governance of ProKidney Holdings and reflect the changes to its capital structure resulting from the Restructuring.
25
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
As used in this Quarterly Report on Form 10-Q, the “Company”, the “Registrant”, “we” or “us” refer to ProKidney Corp. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes that appear elsewhere in this report. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, assumptions and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in the Risk Factors section of the Annual Report on Form 10-K filed with the Securities and Exchange Commission, and elsewhere in this report under “Part II, Other Information—Item 1A, Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies and operations, financing plans, potential growth opportunities, potential market opportunities, potential results of our drug development efforts or trials, and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s plans, estimates, assumptions and beliefs only as of the date of this report. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Overview
ProKidney, a pioneer in the treatment of chronic kidney disease (“CKD”) through innovations in cell therapy, was founded in 2015 after a decade of research. We are a clinical-stage biotechnology company with a proprietary cell therapy platform that has the potential to treat CKD using a patient’s own cells. Our approach seeks to redefine the treatment of CKD, shifting the emphasis away from management of kidney failure to the preservation of kidney function.
ProKidney’s lead product candidate, rilparencel (also known as REACT®), is a first-in-class, patented, proprietary autologous cell therapy being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy’s potential to preserve kidney function in patients with type 2 diabetes and advanced CKD. Rilparencel received Regenerative Medicine Advanced Therapy (“RMAT”) designation from the United States Food & Drug Administration (“FDA”).
Since our inception, we have devoted substantially all of our resources to organizing and staffing our company, business and scientific planning, conducting discovery and research activities, establishing and protecting our intellectual property portfolio, developing and progressing rilparencel, raising capital, sponsoring clinical trials, establishing arrangements with third parties for the manufacture of component materials, and providing general and administrative support for these operations. We do not have any product candidates approved for sale and have not generated any revenue from product sales.
Recent Developments
PROACT 1:
PROACT 1 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with type 2 diabetes and advanced CKD. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (estimated glomerular filtration rate (“eGFR”) 20-30 mL/min/1.73m2) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m2) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m2 and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m2). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The surrogate endpoint for accelerated approval is eGFR slope, and the primary composite endpoint is the time from first injection to the earliest of: at least 40% reduction in eGFR; eGFR <15 mL/min/1.73m², and/or chronic dialysis, and/or kidney transplant; or kidney or cardiovascular death.
In a recent Type B meeting, the FDA confirmed that the slope of eGFR in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (“BLA”) submission of rilparencel under the accelerated approval pathway. The FDA agreed that a rilparencel effect size (versus sham controls) of at least 1.5 mL/min/1.73m2/year improvement would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies. We anticipate topline data readout of eGFR slope as the surrogate endpoint to support an application for accelerated approval in the second quarter of 2027. We have enrolled nearly half of the patients required for the accelerated approval analysis. The FDA also confirmed that the ongoing Phase 3 PROACT 1 study may serve as the confirmatory study to support full
26
approval of rilparencel based on the primary time-to-event composite endpoint specified in the protocol. Updated guidance on the expected timing of the confirmatory readout will be provided in the first half of 2026.
REGEN-007:
We recently completed our REGEN-007 trial, a multi-center Phase 2 open-label 1:1 randomized two-arm trial of rilparencel in patients with diabetes, CKD, and an eGFR of 20-50 mL/min/1.73m². At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of our ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of ≥ 20%, and/or an increase in the urine albumin to creatinine ratio (“UACR”) from baseline of ≥ 30% and ≥ 30 mg/g.
The prespecified primary endpoint for REGEN-007 is the difference in annual eGFR slope (calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparencel injection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as the on-study central laboratory eGFR results prior to first rilparencel injection. The period following the last injection included eGFR values from the last rilparencel injection to the end of study (EOS) visit. Median follow-up after the last injection was approximately 18 months in both Group 1 and Group 2.
Fifty-three patients were randomized in the study, of whom 49 patients (mITT population) received at least one rilparencel injection. Four patients did not receive any rilparencel injections. The majority of patients were male (69%), and the mean age was 60 years. At baseline, 38 of 49 patients (78%) had type 2 diabetes mellitus and 11 (22%) had type 1 diabetes. Thirty-nine (80%) patients were receiving an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), and 18 (37%) were receiving a sodium-glucose cotransporter-2 inhibitor (SGLT2i). At baseline, the mean (SD) eGFR was 33±10 mL/min/1.73m2. Notably, the median UACR was higher in Group 1 (792 mg/g) compared to Group 2 (229 mg/g).
|
|
Annual eGFR Slope (mL/min/1.73m2) |
|||
Group |
N (mITT) |
Pre inj |
Post last inj |
Absolute benefit |
Relative benefit |
1 |
24 |
-5.8 |
-1.3 |
4.6 |
78% |
2 |
25 |
-3.4 |
-1.7 |
1.7 |
50% |
In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in eGFR slope improved by 78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful. Of the 24 patients in Group 1, 15 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. The Phase 3 PROACT 1 protocol was amended in the first half of 2024 after a similar eGFR efficacy signal was observed in the Phase 2 RMCL-002 study subgroup analysis (n=23) of high-UACR, Stage 4 CKD patients with type 2 diabetes.
In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 mL/min/1.73m2 in the period following the last rilparencel injection, resulting in an improvement of 50%, or 1.7 mL/min/1.73m2 per year. This difference was not statistically significant (p=0.085) but suggests evidence of a dose response. Out of the 25 patients in Group 2, 15 (60%) met the re-dosing trigger and received a second rilparencel injection. The median time between the first and second injections in these 15 patients was approximately 11 months.
No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy.
Full results from REGEN-007 will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial.
Completion of Domestication
Effective July 1, 2025 (the “Domestication Date”), we completed a domestication process through which we changed our jurisdiction of incorporation from the Cayman Islands to the State of Delaware (the “Domestication”). In connection with the Domestication, we also completed certain other restructuring transactions (such transactions, together with the Domestication, the “Restructuring”) on the Domestication Date. Prior to the Restructuring, we conducted our business indirectly through ProKidney LP (“PKLP”), a limited partnership under the laws and regulations of Ireland, and its subsidiaries. As part of the Restructuring, (i) PKLP contributed substantially all of its assets to a newly formed subsidiary, ProKidney Holdings, LLC, a Delaware limited liability company (“ProKidney Holdings”) (other than its limited liability company interests in ProKidney Holdings), (ii) PKLP commenced winding-up and made a liquidating distribution of its limited liability company interests in ProKidney Holdings to its partners,
27
including the Company, in redemption of their interests in PKLP, and (iii) ProKidney Corp. GP Limited, the general partner of PKLP, sold its nominal economic interest in ProKidney Holdings received in such liquidating distribution to us (collectively, the “Substitution”). Immediately following the Domestication, ProKidney, then a wholly owned subsidiary of ProKidney Holdings and a Cayman Islands exempted company, re-registered as a Cayman Islands limited liability company and then deregistered as a limited liability company in the Cayman Islands and registered by way of continuation out for purposes of the Limited Liability Companies Act (as amended) of the Cayman Islands and domesticated and continued for purposes of the Delaware Limited Liability Company Act as a Delaware limited liability company named ProKidney IPCo, LLC (“ProKidney IPCo”). As a result of the consummation of the Domestication and the other transactions involved in the Restructuring, we and the other former limited partners of PKLP are now members of ProKidney Holdings, and ProKidney Holdings owns all of the subsidiaries that conduct our business, including ProKidney IPCo.
In connection with the Domestication and the other Restructuring transactions, we amended and restated certain of its material agreements, each originally dated July 11, 2022, on substantially similar terms in order to reflect updates to our corporate structure resulting from the Restructuring including (i) an Amended and Restated Tax Receivable Agreement, (ii) an Amended and Restated Lock-Up Agreement, and (iii) an Amended and Restated Exchange Agreement. In addition, on the Domestication Date, we, together with the other former limited partners of PKLP, also entered into the Second Amended and Restated Limited Liability Company Agreement of ProKidney Holdings to provide for the governance of ProKidney Holdings and reflect the changes to our capital structure resulting from the Restructuring.
For presentation purposes, unless otherwise noted, “ordinary shares” before the domestication and “common stock” subsequent to the domestication are referred to herein as common stock.
Financial Operations Overview
Revenue
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for rilparencel or any other product candidates are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements.
Beginning in the three months ended December 31, 2024, we recognized revenue related to leasing activities associated with existing lease agreements assumed through the acquisition of two buildings in Winston-Salem, North Carolina where we also conduct our manufacturing operations.
Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred in connection with our research and development activities, including the development of rilparencel.
Research and development costs include:
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated balance sheets as prepaid clinical or as a component of total accrued expenses and other. Nonrefundable advance payments for goods
28
or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is no alternative future use for the research and development. The capitalized amounts are recorded as prepaid clinical and are expensed as the related goods are delivered or the services are performed.
Research and development activities are central to our business model. We expect that our research and development expenses will increase significantly for the foreseeable future as rilparencel moves into later stages of clinical development.
The successful development of rilparencel and any product candidates we may develop in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of rilparencel or potential future product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of:
Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never obtain regulatory approval for any of our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and equity-based compensation expenses for individuals involved in our executive, finance, corporate and administrative functions, as well as expenses for outside professional services, including legal, audit, accounting and tax-related services and other consulting fees,
29
facility-related expenses, which include depreciation costs and other allocated expenses for rent and maintenance of facilities, insurance costs, recruiting costs, travel expenses and other general administrative expenses.
We expect that our general and administrative expenses will increase for the foreseeable future as our business expands and we hire additional personnel to support our operations.
Other Income (Expense)
Other income consists primarily of interest income earned on cash, cash equivalents and marketable securities.
Income Tax Expense
Income tax expense reflects federal and state taxes on income earned by our subsidiary that is organized as a C corporation for U.S. income tax purposes.
Results of Operations
Comparison of Three Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024 (in thousands):
|
|
Three Months Ended June 30, |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Revenue |
|
$ |
221 |
|
|
$ |
– |
|
|
$ |
221 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
25,882 |
|
|
|
29,404 |
|
|
|
(3,522 |
) |
General and administrative |
|
|
14,048 |
|
|
|
13,652 |
|
|
|
396 |
|
Total operating expense |
|
|
39,930 |
|
|
|
43,056 |
|
|
|
(3,126 |
) |
Loss from operations |
|
|
(39,709 |
) |
|
|
(43,056 |
) |
|
|
3,347 |
|
Interest income |
|
|
3,593 |
|
|
|
4,537 |
|
|
|
(944 |
) |
Interest expense |
|
|
(1 |
) |
|
|
(3 |
) |
|
|
2 |
|
Net loss before taxes |
|
|
(36,117 |
) |
|
|
(38,522 |
) |
|
|
2,405 |
|
Income tax expense (benefit) |
|
|
848 |
|
|
|
(56 |
) |
|
|
904 |
|
Net loss before noncontrolling interest |
|
|
(36,965 |
) |
|
|
(38,466 |
) |
|
|
1,501 |
|
Net loss attributable to noncontrolling interest |
|
|
(20,413 |
) |
|
|
(25,960 |
) |
|
|
5,547 |
|
Net loss available to Class A common stockholders |
|
$ |
(16,552 |
) |
|
$ |
(12,506 |
) |
|
$ |
(4,046 |
) |
Research and development expenses
The decrease in research and development expenses of approximately $3.5 million was primarily due to the following:
General and administrative expenses
The increase in general and administrative expenses of approximately $0.4 million was primarily driven by the following:
30
Interest income
The decrease in interest income of approximately $0.9 million was driven primarily by lower investment balances and interest rates for the 2025 period.
Income tax expense
The change in income tax expense was driven by the change in the taxable income associated with the U.S. entities that are treated as corporations for U.S. tax purposes.
Comparison of Six Months Ended June 30, 2025 and 2024
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
|
|
Six Months Ended June 30, |
|
|||||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Revenue |
|
$ |
451 |
|
|
$ |
– |
|
|
$ |
451 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
53,145 |
|
|
|
56,637 |
|
|
|
(3,492 |
) |
General and administrative |
|
|
28,403 |
|
|
|
26,495 |
|
|
|
1,908 |
|
Total operating expense |
|
|
81,548 |
|
|
|
83,132 |
|
|
|
(1,584 |
) |
Loss from operations |
|
|
(81,097 |
) |
|
|
(83,132 |
) |
|
|
2,035 |
|
Interest income |
|
|
7,620 |
|
|
|
9,380 |
|
|
|
(1,760 |
) |
Interest expense |
|
|
(1 |
) |
|
|
(5 |
) |
|
|
4 |
|
Net loss before taxes |
|
|
(73,478 |
) |
|
|
(73,757 |
) |
|
|
279 |
|
Income tax expense |
|
|
1,439 |
|
|
|
42 |
|
|
|
1,397 |
|
Net loss before noncontrolling interest |
|
|
(74,917 |
) |
|
|
(73,799 |
) |
|
|
(1,118 |
) |
Net loss attributable to noncontrolling interest |
|
|
(41,631 |
) |
|
|
(51,801 |
) |
|
|
10,170 |
|
Net loss available to Class A common stockholders |
|
$ |
(33,286 |
) |
|
$ |
(21,998 |
) |
|
$ |
(11,288 |
) |
Research and development expenses
The decrease in research and development expenses of $3.5 million was primarily due to the following:
General and administrative expenses
The increase in general and administrative expenses of approximately $1.9 million was primarily driven by the following:
Interest income
The decrease in interest income of approximately $1.8 million was driven primarily by lower investment balances and interest rates for the 2025 period.
31
Income tax expense
The change in income tax expense was driven by the change in the taxable income associated with the U.S. entities that are treated as corporations for U.S. tax purposes.
Liquidity and Capital Resources
Sources of liquidity
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. From our inception through June 30, 2025, we funded our operations primarily through capital contributions from the holders of PKLP, the proceeds obtained through the Business Combination and related private placement financing, and public equity offerings.
In January 2024, we entered into an Open Market Sale AgreementSM (“2024 Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent, pursuant to which we could offer and sell, from time to time, through Jefferies, shares of our Class A common stock having an aggregate offering price of up to $100.0 million by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”). The shares were offered and sold pursuant to our shelf registration statement on Form S-3. As of June 30, 2025, we had sold $7.9 million worth of Class A common stock under the 2024 Sales Agreement for net proceeds of $7.7 million.
In July 2025, we terminated the 2024 Sales Agreement and entered into a new Open Market Sale AgreementSM with Jefferies, as the sales agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our Class A common stock having an aggregate offering price of up to $200.0 million by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. The shares are offered and sold pursuant to our shelf registration statement on Form S-3.
In June 2024, we sold 46,886,452 shares of our Class A common stock in an underwritten public offering at a price of $2.42 per share. Additionally, in June 2024, the Company sold 11,030,574 shares of its Class A common stock to certain investors at a price of $2.42 per share in a concurrent registered direct offering pursuant to share purchase agreements. The net proceeds to us from the offerings were approximately $136.7 million, after deducting the underwriting discounts and commissions and offering expenses payable by us. The shares were offered and sold pursuant to our shelf registration statement on Form S-3.
We expect that our existing cash, cash equivalents and marketable securities held at June 30, 2025, will enable us to fund our operating expenses and capital expenditure requirements into mid-2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
We expect our expenses to increase substantially if, and as, we:
In addition, since the closing of the Business Combination we have begun incurring additional costs associated with operating as a public company, including significant legal, audit, accounting, investor and public relations, regulatory, tax-related, director and officer insurance premiums and other expenses. Developing pharmaceutical products, including conducting clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any product candidate for which we may obtain marketing approval. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of product that we do not expect to be commercially available for at least several years, if ever.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the public or private sale of equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity
32
financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our technology, future- revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our shares. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
Cash Flows
Cash Flows for the Six Months Ended June 30, 2025 and 2024
The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):
|
|
Six Months Ended June 30, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash flows used in operating activities |
|
$ |
(61,008 |
) |
|
$ |
(72,939 |
) |
Net cash flows provided by investing activities |
|
|
46,854 |
|
|
|
86,969 |
|
Net cash flows (used in) provided by financing activities |
|
|
(26 |
) |
|
|
139,829 |
|
Net change in cash and cash equivalents |
|
$ |
(14,180 |
) |
|
$ |
153,859 |
|
Operating Activities
Net cash used in operating activities was approximately $61.0 million for the six months ended June 30, 2025, reflecting a net loss of approximately $74.9 million along with cash used by changes in working capital of approximately $0.8 million. Such uses were partially offset by non-cash charges and gains on investments of $14.1 million. The non-cash charges primarily consisted of equity-based compensation expense of $13.0 million, depreciation and amortization expense of $3.1 million and gains on marketable securities of $1.9 million. The changes in working capital primarily relate to the timing of payments made to our vendors for services performed and the recognition of receivable amounts related to interest on our marketable security investments.
Net cash used in operating activities was approximately $72.9 million for the six months ended June 30, 2024, reflecting net loss of $73.8 million, and uses driven by changes in working capital of approximately $13.3 million and non-cash charges and gains on investments of $14.1 million. The non-cash charges primarily consisted of equity-based compensation expense of $15.5 million, depreciation and amortization expense of $2.4 million and gains on marketable securities of $3.8 million.
The approximately $11.8 million decrease in cash used in operating activities for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily driven by a decrease in the use of cash related to the timing of payments to our vendors and receipt of interest due.
Investing Activities
Net cash provided by investing activities was approximately $46.9 million and $87.0 million for the six months ended June 30, 2025 and 2024, respectively. The cash provided by investing activities during the three months ended June 30, 2025 and 2024 was primarily related to timing of the conversion of investments to cash and cash equivalents or use to fund our operations.
Financing Activities
Net cash used in financing activities for the six months ended June 30, 2025 was insignificant. The cash provided by financing activities during the six months ended June 30, 2024 of $139.8 million was primarily related to the sale of our Class A common stock through an underwritten public offering and concurrent registered direct offering in June 2024.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our condensed consolidated financial statements. Our condensed consolidated financial statements are prepared in accordance with GAAP. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and judgments
33
that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
Our significant accounting policies are described in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Recent Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
JOBS Act Accounting Election
We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards applicable to public companies, allowing them to delay the adoption of those standards until those standards would otherwise apply to private companies. We have elected to use this extended transition period under the JOBS Act. As a result, our consolidated financial statements may not be comparable to the financial statements of companies that are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make our common stock less attractive to investors.
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 otherwise required under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, management has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) of the Securities Exchange Act of 1934, as amended) as of June 30, 2025. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2025, our disclosure controls and procedures were effective in causing material information relating to us (including our consolidated subsidiaries) to be recorded, processed, summarized and reported by management on a timely basis and to ensure the quality and timeliness of our public disclosures pursuant to SEC disclosure obligations.
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, with the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error and mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of controls.
The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, a control may become inadequate because of changes in conditions or because the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.
34
Changes to Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Website Availability of Reports and other Corporate Governance Information
The Company maintains a comprehensive corporate governance program, including Corporate Governance Guidelines for its Board of Directors, Board Guidelines for Assessing Director Independence and charters for its Audit Committee, Nominating and Corporate Governance Committee and Talent and Compensation Committee. The Company maintains a corporate investor relations website, https://investors.prokidney.com/, where stockholders and other interested persons may review, without charge, among other things, corporate governance materials and certain SEC filings, which are generally available on the same business day as the filing date with the SEC on the SEC’s website http://www.sec.gov. The contents of our website are not made a part of this Quarterly Report on Form 10-Q.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently a party to any material legal proceedings.
Item 1A. Risk Factors.
Our business is subject to a number of risks, including risks that may prevent us from achieving our business objectives or may adversely affect our business, financial condition, results of operations, cash flows, and prospects. These risks are discussed more fully in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 17, 2025 (the “2024 Annual Report”), and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 12, 2025 (“1Q Form 10-Q”). There have been no material changes to the risk factors described in the 2024 Annual Report and 1Q Form 10-Q.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
There were no sales of unregistered equity securities during the three months ended June 30, 2025.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
During the quarter ended June 30, 2025, none of the Company’s directors or officers
Item 6. Exhibits.
Exhibit Number |
|
Description |
|
|
|
3.1 |
|
Certificate of Incorporation of ProKidney (incorporated by reference to Exhibit 3.1 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
3.2 |
|
Bylaws of ProKidney (incorporated by reference to Exhibit 3.2 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
3.3 |
|
Certificate of Corporate Domestication of ProKidney (incorporated by reference to Exhibit 3.3 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
35
4.1 |
|
Stock Certificate for Class A Common Stock ProKidney (incorporated by reference to Exhibit 4.1 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
4.2 |
|
Stock Certificate for Class B Common Stock ProKidney (incorporated by reference to Exhibit 4.2 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.1 |
|
Amended and Restated Tax Receivable Agreement, dated July 1, 2025, by and among ProKidney and the TRA Parties (as defined therein) (incorporated by reference to Exhibit 10.1 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.2 |
|
Amended and Restated Lock-Up Agreement, dated July 1, 2025, by and among ProKidney and certain of the ProKidney Holders (as defined therein) (incorporated by reference to Exhibit 10.2 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.3 |
|
Amended and Restated Exchange Agreement, dated July 1, 2025, by and among ProKidney, ProKidney Holdings, LLC and the other members of ProKidney Holdings, LLC party thereto (incorporated by reference to Exhibit 10.3 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.4 |
|
First Amendment to the ProKidney Corp. Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.4 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.5 |
|
First Amendment to the ProKidney Corp. 2022 Incentive Equity Plan (incorporated by reference to Exhibit 10.5 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.6 |
|
Form of Indemnification Agreement, dated July 1, 2025, by and among ProKidney and its directors and officers (incorporated by reference to Exhibit 10.6 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.7 |
|
Second Amended and Restated Limited Liability Company Agreement of ProKidney Holdings, dated July 1, 2025, by and among the members and managers party thereto (incorporated by reference to Exhibit 10.7 of the Company's Current Report on Form 8-K12B, filed on July 3, 2025 (File No. 0.001-40560)). |
|
|
|
10.8†* |
|
Employment Agreement, dated as of May 12, 2025 by and between Bruce Culleton, M.D. and ProKidney, LLC. |
|
|
|
10.9†* |
|
Employment Agreement, dated as of May 12, 2025 by and between James Coulston and ProKidney, LLC. |
|
|
|
10.10†* |
|
Employment Agreement, dated as of May 9, 2025 by and between Todd Girolamo and ProKidney, LLC. |
|
|
|
10.11†* |
|
Employment Agreement, dated as of June 11, 2025 by and between Darin Weber and ProKidney, LLC. |
|
|
|
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* |
|
The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, formatted in iXBRL (Inline Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets (unaudited), (ii) Condensed Consolidated Statements of Operations (unaudited), (iii) Condensed Consolidated Statements of Comprehensive Loss (unaudited), (iv) Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Stockholders’ Deficit (unaudited), (v) Consolidated Statements of Cash Flows (unaudited) and (vi) Notes to Condensed Consolidated Financial Statements (unaudited), tagged as blocks of text and including detailed tags. |
|
|
|
104* |
|
The cover page from this Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, formatted in Inline XBRL. |
|
|
|
† Management contract or compensatory plan or arrangement
* Filed herewith.
36
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
|
|
Company Name |
|
|
|
|
|
Date: August 12, 2025 |
|
By: |
/s/ Bruce Culleton |
|
|
|
Name: Bruce Culleton |
|
|
|
Title: Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
Date: August 12, 2025 |
|
By: |
/s/ James Coulston |
|
|
|
Name: James Coulston |
|
|
|
Title: Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |
37
Source:
FAQ
What were ProKidney's key financial results in Q2 2025 (PROK)?
What regulatory path did the FDA confirm for rilparencel in PROACT 1?
What efficacy signal did the REGEN-007 Phase 2 trial show?
When does ProKidney expect topline data for the accelerated approval analysis?
How large is the redeemable noncontrolling interest and what does it mean?
