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[10-Q] enVVeno Medical Corporation Quarterly Earnings Report

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Rhea-AI Filing Summary

enVVeno Medical (NVNO) remains pre-revenue but is progressing its venous-valve pipeline while absorbing higher operating costs. In Q2-25 the company reported a net loss of $6.7 m (-0.33/sh), 35 % wider than Q2-24, driven by a 58 % jump in SG&A to $4.2 m (severance, stock comp and a $0.6 m reserve for prepaid clinical costs). R&D spend held essentially flat at $2.9 m.

Cash, cash equivalents and short-term Treasuries fell to $35.1 m from $43.2 m at YE-24; operating cash burn was $7.7 m for the first half. Working capital totals $32.6 m and management believes liquidity is adequate for ≥12 months, but it forecasts quarterly burn to rise to $5-7 m as trials advance.

  • Pipeline: VenoValve PMA filing completed Nov-24 and is under FDA breakthrough-priority review; decision expected 2H-25.
  • Interim two-year data (n=42) show 83 % of pivotal-trial patients retain ≥3-point rVCSS improvement, 74 % median pain reduction and 100 % valve patency (n=30).
  • enVVe transcatheter valve finished GLP study; IDE submission targeted Q3-25.
  • 19.2 m shares outstanding after exercising 1.7 m pre-funded warrants.

Key takeaways: Clinical results and regulatory momentum are constructive, but losses, cash draw and the absence of revenue keep financing risk on the table.

enVVeno Medical (NVNO) rimane senza ricavi ma sta avanzando nel suo programma sulle valvole venose, nonostante l'aumento dei costi operativi. Nel secondo trimestre 2025 la società ha riportato una perdita netta di 6,7 milioni di dollari (-0,33 per azione), il 35% in aumento rispetto al Q2-24, a causa di un incremento del 58% delle spese generali e amministrative a 4,2 milioni di dollari (includendo indennità di fine rapporto, compensi azionari e una riserva di 0,6 milioni per costi clinici prepagati). Le spese per ricerca e sviluppo sono rimaste sostanzialmente stabili a 2,9 milioni di dollari.

La liquidità, comprensiva di contanti, equivalenti e titoli di Stato a breve termine, è scesa a 35,1 milioni di dollari dai 43,2 milioni di fine 2024; il consumo di cassa operativo è stato di 7,7 milioni nella prima metà dell'anno. Il capitale circolante ammonta a 32,6 milioni e il management ritiene che la liquidità sia sufficiente per almeno 12 mesi, anche se prevede un aumento del burn trimestrale a 5-7 milioni con l’avanzare delle sperimentazioni.

  • Pipeline: la presentazione della domanda PMA per VenoValve è stata completata a novembre 2024 ed è attualmente in revisione prioritaria FDA per breakthrough; la decisione è attesa nella seconda metà del 2025.
  • I dati intermedi a due anni (n=42) mostrano che l’83% dei pazienti della sperimentazione principale mantiene un miglioramento di almeno 3 punti nel rVCSS, una riduzione mediana del dolore del 74% e il 100% di pervietà valvolare (n=30).
  • La valvola transcatetere enVVe ha completato lo studio GLP; la presentazione IDE è prevista per il terzo trimestre 2025.
  • Le azioni in circolazione sono 19,2 milioni dopo l’esercizio di 1,7 milioni di warrant pre-finanziati.

Conclusioni chiave: I risultati clinici e il progresso regolatorio sono positivi, ma le perdite, il consumo di cassa e l’assenza di ricavi mantengono il rischio finanziario presente.

enVVeno Medical (NVNO) sigue sin generar ingresos pero avanza en su cartera de válvulas venosas mientras asume mayores costos operativos. En el segundo trimestre de 2025, la compañía reportó una pérdida neta de 6,7 millones de dólares (-0,33 por acción), un 35 % mayor que en el Q2-24, impulsada por un aumento del 58 % en gastos generales y administrativos a 4,2 millones (indemnizaciones, compensación en acciones y una reserva de 0,6 millones para costos clínicos prepagados). El gasto en I+D se mantuvo prácticamente estable en 2,9 millones.

El efectivo, equivalentes de efectivo y bonos del Tesoro a corto plazo disminuyeron a 35,1 millones desde 43,2 millones a fin de 2024; la quema operativa de efectivo fue de 7,7 millones en el primer semestre. El capital de trabajo totaliza 32,6 millones y la dirección considera que la liquidez es adecuada para ≥12 meses, aunque pronostica que la quema trimestral aumentará a 5-7 millones a medida que avancen los ensayos.

  • Cartera: La presentación PMA de VenoValve se completó en noviembre de 2024 y está bajo revisión prioritaria breakthrough de la FDA; se espera decisión en la segunda mitad de 2025.
  • Datos interinos a dos años (n=42) muestran que el 83 % de los pacientes del ensayo pivotal mantienen una mejora ≥3 puntos en rVCSS, una reducción mediana del dolor del 74 % y un 100 % de permeabilidad valvular (n=30).
  • La válvula transcatéter enVVe completó el estudio GLP; se apunta a la presentación IDE en el tercer trimestre de 2025.
  • Hay 19,2 millones de acciones en circulación tras ejercer 1,7 millones de warrants prefinanciados.

Puntos clave: Los resultados clínicos y el impulso regulatorio son positivos, pero las pérdidas, el consumo de efectivo y la ausencia de ingresos mantienen el riesgo financiero presente.

enVVeno Medical (NVNO)는 아직 매출이 없지만 정맥 판막 파이프라인을 진행하면서 운영 비용 증가를 흡수하고 있습니다. 2025년 2분기에 회사는 670만 달러(-주당 0.33달러)의 순손실을 보고했으며, 이는 2024년 2분기 대비 35% 확대된 수치로, 판매관리비가 58% 증가한 420만 달러(퇴직금, 주식 보상 및 선불 임상 비용 60만 달러 적립 포함)에 기인합니다. 연구개발 비용은 290만 달러로 거의 변동이 없었습니다.

현금, 현금성 자산 및 단기 국채는 2024년 말 4320만 달러에서 3510만 달러로 감소했으며, 상반기 운영 현금 소진액은 770만 달러였습니다. 운전자본은 3260만 달러이며 경영진은 유동성이 12개월 이상 충분하다고 보고 있으나, 임상시험 진행에 따라 분기별 현금 소진액이 500만~700만 달러로 증가할 것으로 예상합니다.

  • 파이프라인: VenoValve PMA 신청은 2024년 11월 완료되었으며 FDA의 혁신적 우선 심사 중이며, 2025년 하반기에 결정이 예상됩니다.
  • 중간 2년 데이터(n=42)는 주요 임상시험 환자의 83%가 rVCSS 3점 이상 개선을 유지하고, 통증은 중앙값 기준 74% 감소했으며, 판막 개방성은 100%(n=30)를 보였습니다.
  • enVVe 경피 판막은 GLP 연구를 완료했으며 IDE 제출은 2025년 3분기를 목표로 하고 있습니다.
  • 선행 자금 조달 워런트 170만 주 행사 후 발행 주식 수는 1920만 주입니다.

주요 시사점: 임상 결과와 규제 진전은 긍정적이나, 손실, 현금 소진 및 매출 부재로 인해 재무 위험이 여전히 존재합니다.

enVVeno Medical (NVNO) reste sans revenus mais progresse dans son pipeline de valves veineuses tout en absorbant des coûts opérationnels plus élevés. Au T2-25, la société a enregistré une perte nette de 6,7 M$ (-0,33$/action), soit une augmentation de 35 % par rapport au T2-24, due à une hausse de 58 % des frais SG&A à 4,2 M$ (indemnités de licenciement, rémunérations en actions et une provision de 0,6 M$ pour coûts cliniques prépayés). Les dépenses en R&D sont restées stables à 2,9 M$.

La trésorerie, équivalents de trésorerie et bons du Trésor à court terme ont diminué à 35,1 M$ contre 43,2 M$ à la fin 2024; la consommation de trésorerie opérationnelle s’est élevée à 7,7 M$ sur le premier semestre. Le fonds de roulement s’élève à 32,6 M$ et la direction estime que la liquidité est suffisante pour ≥12 mois, mais prévoit une augmentation de la consommation trimestrielle à 5-7 M$ avec l’avancement des essais.

  • Pipeline : Le dépôt PMA de VenoValve a été complété en novembre 2024 et est en cours d’examen prioritaire breakthrough par la FDA; une décision est attendue au second semestre 2025.
  • Les données intermédiaires à deux ans (n=42) montrent que 83 % des patients de l’essai pivot conservent une amélioration ≥3 points au rVCSS, une réduction médiane de la douleur de 74 % et une perméabilité valvulaire à 100 % (n=30).
  • La valve transcatheter enVVe a terminé l’étude GLP; le dépôt IDE est prévu au T3-25.
  • 19,2 M d’actions en circulation après exercice de 1,7 M de warrants préfinancés.

Points clés : Les résultats cliniques et l’élan réglementaire sont encourageants, mais les pertes, la consommation de trésorerie et l’absence de revenus maintiennent un risque de financement.

enVVeno Medical (NVNO) ist weiterhin vor Umsatz, macht jedoch Fortschritte bei seiner venösen Klappen-Pipeline und trägt dabei höhere Betriebskosten. Im zweiten Quartal 2025 meldete das Unternehmen einen Nettoverlust von 6,7 Mio. USD (-0,33 pro Aktie), was eine 35 %ige Zunahme gegenüber Q2-24 darstellt, bedingt durch einen 58 %igen Anstieg der Vertriebs- und Verwaltungskosten auf 4,2 Mio. USD (Abfindungen, Aktienvergütungen und eine Rückstellung von 0,6 Mio. USD für vorausbezahlte klinische Kosten). Die F&E-Ausgaben blieben mit 2,9 Mio. USD im Wesentlichen stabil.

Bargeld, Zahlungsmitteläquivalente und kurzfristige Staatsanleihen sanken von 43,2 Mio. USD zum Jahresende 2024 auf 35,1 Mio. USD; der operative Cash-Burn betrug in der ersten Jahreshälfte 7,7 Mio. USD. Das Working Capital beträgt 32,6 Mio. USD, und das Management hält die Liquidität für mindestens 12 Monate für ausreichend, prognostiziert jedoch einen Anstieg des vierteljährlichen Cash-Burns auf 5-7 Mio. USD mit dem Fortschreiten der Studien.

  • Pipeline: Die PMA-Einreichung für VenoValve wurde im November 2024 abgeschlossen und befindet sich in der FDA-Breakthrough-Prioritätsprüfung; eine Entscheidung wird für die zweite Hälfte 2025 erwartet.
  • Zwischenergebnisse nach zwei Jahren (n=42) zeigen, dass 83 % der Patienten der Schlüsselerhebung eine ≥3-Punkte-Verbesserung im rVCSS behalten, die mediane Schmerzlinderung beträgt 74 % und die Klappenöffnung liegt bei 100 % (n=30).
  • Das enVVe Transkatheter-Ventil hat die GLP-Studie abgeschlossen; die IDE-Einreichung ist für Q3-25 geplant.
  • 19,2 Mio. Aktien sind nach Ausübung von 1,7 Mio. vorfinanzierten Warrants ausstehend.

Wesentliche Erkenntnisse: Klinische Ergebnisse und regulatorischer Fortschritt sind positiv, aber Verluste, Cash-Verbrauch und fehlende Umsätze halten das Finanzierungsrisiko aufrecht.

Positive
  • 83 % of pivotal-trial patients maintained clinically meaningful benefit at two years with 100 % valve patency, supporting VenoValve efficacy.
  • PMA application for VenoValve fully submitted and under breakthrough priority review; potential FDA decision 2H-25.
  • Cash and investments of $35.1 m provide approximately one-year runway, meeting near-term obligations.
  • enVVe GLP study completed; IDE filing expected Q3-25, indicating pipeline progression.
Negative
  • Q2-25 net loss widened by 35 % YoY to $6.7 m; SG&A up 58 % including a $0.6 m reserve.
  • Cash/investments declined $8.6 m since YE-24; projected quarterly burn rising to $5-7 m raises dilution risk.
  • Company remains pre-revenue; all future value hinges on FDA approvals not yet secured.
  • Recorded $0.6 m potentially uncollectible prepaid clinical costs, signaling vendor oversight issues.

Insights

TL;DR: Solid clinical readouts and PMA filing, but burn accelerates and no revenues yet—neutral to modestly positive near term.

The 83 % two-year durability and 100 % patency strengthen VenoValve’s clinical dossier ahead of FDA review, supporting commercial potential in a multi-million-patient market. Priority review could place approval inside the next 12 months, an inflection point for valuation. Cash of $35 m covers roughly six quarters at the guided $5-7 m burn, implying an equity raise is likely post-approval decision. Operating expense inflation (notably SG&A) bears watching, but R&D discipline is reasonable. Overall, the filing is strategically encouraging yet financially neutral until regulatory clarity emerges.

TL;DR: Regulatory, liquidity and execution risks persist despite promising data—net neutral impact.

While breakthrough status accelerates the PMA timeline, FDA outcomes remain binary. A $0.6 m write-off highlights vendor-control risk. Cash runway is adequate for one year, but projected burn escalation suggests dilution risk if approval is delayed. No revenue diversification yet; all value rests on two products still in development. Governance appears adequate, and internal controls were deemed effective. Impact on credit or solvency is limited for the next 12 months, but capital-market dependence continues.

enVVeno Medical (NVNO) rimane senza ricavi ma sta avanzando nel suo programma sulle valvole venose, nonostante l'aumento dei costi operativi. Nel secondo trimestre 2025 la società ha riportato una perdita netta di 6,7 milioni di dollari (-0,33 per azione), il 35% in aumento rispetto al Q2-24, a causa di un incremento del 58% delle spese generali e amministrative a 4,2 milioni di dollari (includendo indennità di fine rapporto, compensi azionari e una riserva di 0,6 milioni per costi clinici prepagati). Le spese per ricerca e sviluppo sono rimaste sostanzialmente stabili a 2,9 milioni di dollari.

La liquidità, comprensiva di contanti, equivalenti e titoli di Stato a breve termine, è scesa a 35,1 milioni di dollari dai 43,2 milioni di fine 2024; il consumo di cassa operativo è stato di 7,7 milioni nella prima metà dell'anno. Il capitale circolante ammonta a 32,6 milioni e il management ritiene che la liquidità sia sufficiente per almeno 12 mesi, anche se prevede un aumento del burn trimestrale a 5-7 milioni con l’avanzare delle sperimentazioni.

  • Pipeline: la presentazione della domanda PMA per VenoValve è stata completata a novembre 2024 ed è attualmente in revisione prioritaria FDA per breakthrough; la decisione è attesa nella seconda metà del 2025.
  • I dati intermedi a due anni (n=42) mostrano che l’83% dei pazienti della sperimentazione principale mantiene un miglioramento di almeno 3 punti nel rVCSS, una riduzione mediana del dolore del 74% e il 100% di pervietà valvolare (n=30).
  • La valvola transcatetere enVVe ha completato lo studio GLP; la presentazione IDE è prevista per il terzo trimestre 2025.
  • Le azioni in circolazione sono 19,2 milioni dopo l’esercizio di 1,7 milioni di warrant pre-finanziati.

Conclusioni chiave: I risultati clinici e il progresso regolatorio sono positivi, ma le perdite, il consumo di cassa e l’assenza di ricavi mantengono il rischio finanziario presente.

enVVeno Medical (NVNO) sigue sin generar ingresos pero avanza en su cartera de válvulas venosas mientras asume mayores costos operativos. En el segundo trimestre de 2025, la compañía reportó una pérdida neta de 6,7 millones de dólares (-0,33 por acción), un 35 % mayor que en el Q2-24, impulsada por un aumento del 58 % en gastos generales y administrativos a 4,2 millones (indemnizaciones, compensación en acciones y una reserva de 0,6 millones para costos clínicos prepagados). El gasto en I+D se mantuvo prácticamente estable en 2,9 millones.

El efectivo, equivalentes de efectivo y bonos del Tesoro a corto plazo disminuyeron a 35,1 millones desde 43,2 millones a fin de 2024; la quema operativa de efectivo fue de 7,7 millones en el primer semestre. El capital de trabajo totaliza 32,6 millones y la dirección considera que la liquidez es adecuada para ≥12 meses, aunque pronostica que la quema trimestral aumentará a 5-7 millones a medida que avancen los ensayos.

  • Cartera: La presentación PMA de VenoValve se completó en noviembre de 2024 y está bajo revisión prioritaria breakthrough de la FDA; se espera decisión en la segunda mitad de 2025.
  • Datos interinos a dos años (n=42) muestran que el 83 % de los pacientes del ensayo pivotal mantienen una mejora ≥3 puntos en rVCSS, una reducción mediana del dolor del 74 % y un 100 % de permeabilidad valvular (n=30).
  • La válvula transcatéter enVVe completó el estudio GLP; se apunta a la presentación IDE en el tercer trimestre de 2025.
  • Hay 19,2 millones de acciones en circulación tras ejercer 1,7 millones de warrants prefinanciados.

Puntos clave: Los resultados clínicos y el impulso regulatorio son positivos, pero las pérdidas, el consumo de efectivo y la ausencia de ingresos mantienen el riesgo financiero presente.

enVVeno Medical (NVNO)는 아직 매출이 없지만 정맥 판막 파이프라인을 진행하면서 운영 비용 증가를 흡수하고 있습니다. 2025년 2분기에 회사는 670만 달러(-주당 0.33달러)의 순손실을 보고했으며, 이는 2024년 2분기 대비 35% 확대된 수치로, 판매관리비가 58% 증가한 420만 달러(퇴직금, 주식 보상 및 선불 임상 비용 60만 달러 적립 포함)에 기인합니다. 연구개발 비용은 290만 달러로 거의 변동이 없었습니다.

현금, 현금성 자산 및 단기 국채는 2024년 말 4320만 달러에서 3510만 달러로 감소했으며, 상반기 운영 현금 소진액은 770만 달러였습니다. 운전자본은 3260만 달러이며 경영진은 유동성이 12개월 이상 충분하다고 보고 있으나, 임상시험 진행에 따라 분기별 현금 소진액이 500만~700만 달러로 증가할 것으로 예상합니다.

  • 파이프라인: VenoValve PMA 신청은 2024년 11월 완료되었으며 FDA의 혁신적 우선 심사 중이며, 2025년 하반기에 결정이 예상됩니다.
  • 중간 2년 데이터(n=42)는 주요 임상시험 환자의 83%가 rVCSS 3점 이상 개선을 유지하고, 통증은 중앙값 기준 74% 감소했으며, 판막 개방성은 100%(n=30)를 보였습니다.
  • enVVe 경피 판막은 GLP 연구를 완료했으며 IDE 제출은 2025년 3분기를 목표로 하고 있습니다.
  • 선행 자금 조달 워런트 170만 주 행사 후 발행 주식 수는 1920만 주입니다.

주요 시사점: 임상 결과와 규제 진전은 긍정적이나, 손실, 현금 소진 및 매출 부재로 인해 재무 위험이 여전히 존재합니다.

enVVeno Medical (NVNO) reste sans revenus mais progresse dans son pipeline de valves veineuses tout en absorbant des coûts opérationnels plus élevés. Au T2-25, la société a enregistré une perte nette de 6,7 M$ (-0,33$/action), soit une augmentation de 35 % par rapport au T2-24, due à une hausse de 58 % des frais SG&A à 4,2 M$ (indemnités de licenciement, rémunérations en actions et une provision de 0,6 M$ pour coûts cliniques prépayés). Les dépenses en R&D sont restées stables à 2,9 M$.

La trésorerie, équivalents de trésorerie et bons du Trésor à court terme ont diminué à 35,1 M$ contre 43,2 M$ à la fin 2024; la consommation de trésorerie opérationnelle s’est élevée à 7,7 M$ sur le premier semestre. Le fonds de roulement s’élève à 32,6 M$ et la direction estime que la liquidité est suffisante pour ≥12 mois, mais prévoit une augmentation de la consommation trimestrielle à 5-7 M$ avec l’avancement des essais.

  • Pipeline : Le dépôt PMA de VenoValve a été complété en novembre 2024 et est en cours d’examen prioritaire breakthrough par la FDA; une décision est attendue au second semestre 2025.
  • Les données intermédiaires à deux ans (n=42) montrent que 83 % des patients de l’essai pivot conservent une amélioration ≥3 points au rVCSS, une réduction médiane de la douleur de 74 % et une perméabilité valvulaire à 100 % (n=30).
  • La valve transcatheter enVVe a terminé l’étude GLP; le dépôt IDE est prévu au T3-25.
  • 19,2 M d’actions en circulation après exercice de 1,7 M de warrants préfinancés.

Points clés : Les résultats cliniques et l’élan réglementaire sont encourageants, mais les pertes, la consommation de trésorerie et l’absence de revenus maintiennent un risque de financement.

enVVeno Medical (NVNO) ist weiterhin vor Umsatz, macht jedoch Fortschritte bei seiner venösen Klappen-Pipeline und trägt dabei höhere Betriebskosten. Im zweiten Quartal 2025 meldete das Unternehmen einen Nettoverlust von 6,7 Mio. USD (-0,33 pro Aktie), was eine 35 %ige Zunahme gegenüber Q2-24 darstellt, bedingt durch einen 58 %igen Anstieg der Vertriebs- und Verwaltungskosten auf 4,2 Mio. USD (Abfindungen, Aktienvergütungen und eine Rückstellung von 0,6 Mio. USD für vorausbezahlte klinische Kosten). Die F&E-Ausgaben blieben mit 2,9 Mio. USD im Wesentlichen stabil.

Bargeld, Zahlungsmitteläquivalente und kurzfristige Staatsanleihen sanken von 43,2 Mio. USD zum Jahresende 2024 auf 35,1 Mio. USD; der operative Cash-Burn betrug in der ersten Jahreshälfte 7,7 Mio. USD. Das Working Capital beträgt 32,6 Mio. USD, und das Management hält die Liquidität für mindestens 12 Monate für ausreichend, prognostiziert jedoch einen Anstieg des vierteljährlichen Cash-Burns auf 5-7 Mio. USD mit dem Fortschreiten der Studien.

  • Pipeline: Die PMA-Einreichung für VenoValve wurde im November 2024 abgeschlossen und befindet sich in der FDA-Breakthrough-Prioritätsprüfung; eine Entscheidung wird für die zweite Hälfte 2025 erwartet.
  • Zwischenergebnisse nach zwei Jahren (n=42) zeigen, dass 83 % der Patienten der Schlüsselerhebung eine ≥3-Punkte-Verbesserung im rVCSS behalten, die mediane Schmerzlinderung beträgt 74 % und die Klappenöffnung liegt bei 100 % (n=30).
  • Das enVVe Transkatheter-Ventil hat die GLP-Studie abgeschlossen; die IDE-Einreichung ist für Q3-25 geplant.
  • 19,2 Mio. Aktien sind nach Ausübung von 1,7 Mio. vorfinanzierten Warrants ausstehend.

Wesentliche Erkenntnisse: Klinische Ergebnisse und regulatorischer Fortschritt sind positiv, aber Verluste, Cash-Verbrauch und fehlende Umsätze halten das Finanzierungsrisiko aufrecht.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2025

 

OR

 

☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to ___________________

 

Commission file number: 001-38325

 

enVVeno Medical Corporation

(Exact name of registrant as specified in its charter)

 

Delaware   33-0936180
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)

 

70 Doppler

Irvine, California 92618

(Address of principal executive offices)

 

(949) 261-2900

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class:   Name of Each Exchange on Which Registered:   Ticker Symbol
Common Stock, $0.00001 par value   The NASDAQ Stock Market LLC   NVNO

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

  Large accelerated filer ☐   Accelerated filer ☐
  Non-accelerated filer ☒   Smaller reporting company ☒
        Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

As of July 29, 2025, there were 19,247,141 shares of common stock outstanding.

 

 

 

 

 

 

ENVVENO MEDICAL CORPORATION

TABLE OF CONTENTS

 

PART I  
   
FINANCIAL INFORMATION  
   
ITEM 1. Financial Statements (unaudited) 1
   
Condensed Balance Sheets as of June 30, 2025 and December 31, 2024 1
   
Condensed Statements of Operations for the three and six months ended June 30, 2025 and 2024 2
   
Condensed Statements of Changes in Stockholders’ Equity for the six months ended June 30, 2025 and 2024 3
   
Condensed Statements of Cash Flows for the six months ended June 30, 2025 and 2024 4
   
Notes to Condensed Financial Statements 5
   
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 9
   
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 14
   
ITEM 4. Controls and Procedures 14
   
PART II  
   
OTHER INFORMATION 15
   
ITEM 1. Legal Proceedings 15
   
ITEM 1A. Risk Factors 15
   
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 15
   
ITEM 3. Defaults Upon Senior Securities 15
   
ITEM 4. Mine Safety Disclosures 15
   
ITEM 5. Other Information 15
   
ITEM 6. Exhibits 16
   
Signatures 17

 

i

 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1 – Financial Statements

 

ENVVENO MEDICAL CORPORATION

CONDENSED BALANCE SHEETS

(In thousands except par values, unless otherwise indicated)

(Unaudited)

 

  

June 30,

2025

  

December 31,

2024

 
    (Unaudited)      
Assets          
Current assets:          
Cash and cash equivalents  $2,044   $1,754 
Short-term investments   33,098    41,399 
Prepaid expenses and other current assets   462    581 
Total current assets   35,604    43,734 
Property and equipment, net   113    182 
Operating lease right-of-use assets, net   829    1,007 
Security deposits and other assets   31    31 
Total assets  $36,577   $44,954 
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable, accrued expenses and other current liabilities  $2,638   $1,731 
Current portion of operating lease liabilities   377    364 
Total current liabilities   3,015    2,095 
Long-term operating lease liabilities   505    700 
Total liabilities   3,520    2,795 
           
Commitments and Contingencies   -    - 
           
Stockholders’ Equity:          
Preferred stock, par value $0.00001, 10,000 shares authorized, no shares issued or outstanding   -    - 
Common stock, par value $0.00001, 250,000 shares authorized, 19,247 and 17,536 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively   -    - 
Additional paid-in capital   196,109    194,014 
Accumulated deficit   (163,052)   (151,855)
Total stockholders’ equity   33,057    42,159 
Total liabilities and stockholders’ equity  $36,577   $44,954 

 

See Notes to these Unaudited Condensed Financial Statements

 

1

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

             
  

For the Three Months Ended

June 30,

  

For the Six Months Ended

June 30,

 
   2025   2024   2025   2024 
Operating expenses:                    
Research and development expenses  $2,891   $2,825   $5,448   $5,877 
Selling, general and administrative expenses   4,158    2,629    6,555    5,080 
Loss from operations   (7,049)   (5,454)   (12,003)   (10,957)
                     
Other income:                    
Realized gains from sales of trading securities   239    379    665    787 
Unrealized gain (loss) from
trading securities		   (79)   46    (273)   90 
Interest income, net   195    73    414    132 
Total other income   355    498    806    1,009 
Net loss  $(6,694)  $(4,956)  $(11,197)  $(9,948)
                     

Net loss per basic and diluted

common share:

  $(0.33)  $(0.31)  $(0.55)  $(0.62)
                     

Weighted average number of

common shares outstanding:

                    
Basic and Diluted   20,352    16,067    20,352    16,062 

 

See Notes to these Unaudited Condensed Financial Statements

 

2

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(In thousands, unless otherwise indicated)

(Unaudited)

 

   Shares   Amount   Capital   Deficit   Equity 
   Three Months Ended June 30, 2025 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, April 1, 2025   17,536   $-   $194,665   $(156,358)  $38,307 
Common stock issued for exercise of pre-funded warrants   1,711    -    -    -    - 
Stock-based compensation   -    -    1,444    -    1,444 
Net loss   -    -    -    (6,694)   (6,694)
Balance, June 30, 2025   19,247   $-   $196,109   $(163,052)  $33,057 

 

   Three Months Ended June 30, 2024 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, April 1, 2024   13,330   $-   $177,397   $(135,028)  $42,369 
Stock-based compensation   -    -    1,005    -    1,005 
Net loss   -    -    -    (4,956)   (4,956)
Balance, June 30, 2024   13,330   $-   $178,402   $(139,984)  $38,418 

 

   Six Months Ended June 30, 2025 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, January 1, 2025   17,536   $-   $194,014   $(151,855)  $42,159 
Stock-based compensation   -    -    2,095    -    2,095 
Common stock issued for exercise of pre-funded warrants   1,711    -    -    -    - 
Net loss   -    -    -    (11,197)   (11,197)
Balance, June 30, 2025   19,247   $-   $196,109   $(163,052)  $33,057 

 

   Six Months Ended June 30, 2024 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, January 1, 2024   13,317   $-   $176,236   $(130,036)  $46,200 
                          
Stock-based compensation   -    -    2,120    -    2,120 
Options exercised   13    -    46    -    46 
Net loss   -    -    -    (9,948)   (9,948)
Balance, June 30, 2024   13,330   $-   $178,402   $(139,984)  $38,418 

 

See Notes to these Unaudited Condensed Financial Statements

 

3

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(In thousands, unless otherwise indicated)

(Unaudited)

 

       
   For the Six Months Ended June 30, 
   2025   2024 
Cash Flows from Operating Activities          
Net loss  $(11,197)  $(9,948)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation   2,095    2,120 
Depreciation and amortization   74    106 
Amortization of right-of-use assets   178    171 
Unrealized (gain) loss from investments   273    (90)
Changes in operating assets and liabilities:          
Prepaid expenses and other current assets   119    42 
Accounts payable, accrued expenses and other current liabilities   907    311 
Operating lease liabilities   (182)   (169)
Net cash used in operating activities   (7,733)   (7,457)
           
Cash Flows from Investing Activities          
Maturities of investments   24,835    31,263 
Purchase of property and equipment   (5)   (24)
Purchases of investments   (16,807)   (25,068)
Net cash provided by investing activities   8,023    6,171 
           
Cash Flows from Financing Activities          
Proceeds from stock option exercises   -    46 
Net cash provided by financing activities   -    46 
Net increase (decrease) in cash and cash equivalents   290    (1,240)
Cash and cash equivalents - Beginning of period   1,754    3,620 
Cash and cash equivalents - End of period  $2,044   $2,380 

 

See Notes to these Unaudited Condensed Financial Statements

 

4

 

 

ENVVENO MEDICAL CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 1 – Business Organization and Nature of Operations

 

enVVeno Medical Corporation (the “Company”) is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg.

 

The Company’s lead product is the VenoValve®, a potential first of its kind surgical replacement venous valve currently in post-enrollment follow-up of its U.S. pivotal study. The Company is also developing a second product called enVVe®, a next-generation, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

 

The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (“FDA”). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option.

 

Note 2 – Management’s Liquidity Plan

 

As of June 30, 2025, the Company had a cash and investment balance of $35.1 million and working capital of $32.6 million. Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, management believes that the Company’s capital resources are sufficient to meet its obligations as they become due within one year after the date of this Quarterly Report, and sustain operations.

 

Note 3 – Significant Accounting Policies

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company as of June 30, 2025 and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024.

 

The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K/A filed with the SEC on February 28, 2025. The accompanying condensed balance sheet as of December 31, 2024 has been derived from the Company’s audited financial statements.

 

5

 

 

Note 4 – Investments

 

The components of investments at June 30, 2025 and December 31, 2024 were as follows:

Schedule of Components of Investments 

   June 30, 2025   December 31, 2024 
(In thousands) 

Cash

Equivalents

  

Short-Term

Investments

  

Cash

Equivalents

  

Short-Term

Investments

 
Fair Value Level 1                
U.S. Government securities  $1,465   $33,098   $1,352   $41,399 
Total debt investments  $1,465   $33,098   $1,352   $41,399 

 

Unrealized and realized gains and losses on the accompanying statement of operations result from fixed-income securities and are primarily attributable to changes in interest rates. Management does not believe any remaining unrealized losses represent impairments based on its evaluation of available evidence.

 

Note 5 – Concentrations

 

The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $0.7 million and $0.9 million as of June 30, 2025 and December 31, 2024, respectively.

 

Note 6 – Accounts Payable Accrued Expenses and Other Current Liabilities

 

As of June 30, 2025, and December 31, 2024, accounts payable, accrued expenses and other current liabilities consist of the following:

Schedule of Accounts Payable, Accrued Expenses and Other Current Liabilities 

(In thousands) 

June 30,

2025

  

December 31,

2024

 
Accounts payable  $1,073   $1,006 
Accrued compensation costs   629    604 
Accrued clinical costs   576    - 
Accrued severance   257    - 
Other accrued expenses   103    121 
Total accounts payable, accrued expenses and other current liabilities  $2,638   $1,731 

 

Note 7 – Commitments and Contingencies

 

Litigations Claims and Assessments

 

In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

 

6

 

 

Note 8 –Stockholders’ Equity

 

Omnibus Incentive Plan

 

Stock Options

 

Stock-based compensation expense is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $1.4 million and $1.0 million during the three months ended June 30, 2025 and 2024, respectively, and $2.1 million during the six months ended June 30, 2025 and 2024. As of June 30, 2025, there was $4.4 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 2.02 years.

 

There were 600,000 and 423,000 options granted during the three and six months ended June 30, 2025 and 2024, respectively, in connection with entering into certain employment and consulting agreements.

 

There were approximately 529,000 option grants forfeited during the three and six months ended June 30, 2025. There were 19,000 and 42,000 option grants forfeited during the three and six months ended June 30, 2024.

 

There were no option grants exercised during the three and six months ended June 30, 2025. There were no option grants exercised during the three months ended June 30, 2024 and there were 13,000 option grants exercised during the six months ended June 30, 2024.

 

Restricted Stock Units

 

Restricted stock unit vesting is conditioned on achieving the Pre-Market Approval of the VenoValve milestone. During the three and six months ended June 30, 2025, there were 50,000 restricted stock units forfeited in connection with employment termination. No expense has been recorded as of June 30, 2025.

 

Warrants

 

Pre-funded warrants issued in 2023 and 2021 totaling approximately 861,000 and 850,000 units, respectively, were exercised during the three and six months ended June 30, 2025, at an exercise price of $0.0001 per share.

 

Note 9 – Net Loss per Share

 

The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of June 30, 2025 and 2024:

Schedule of Potentially Dilutive Common Stock Equivalents Excluded From Calculation of Diluted Net Loss Per Common Share 

       
(In thousands)  June 30, 
   2025   2024 
Shares of common stock issuable upon exercise of warrants   9,447    9,546 
Shares of common stock issuable upon exercise of options   6,343    5,554 
Potentially dilutive common stock equivalents excluded from diluted net loss per share   15,790    15,100 

 

Note 10 – Segment Reporting

 

The Company has determined that it currently operates in a single segment, Medical Device development, located in a single geographic location, the United States. The accounting policies of the segment are the same as those described in the summary of significant accounting policies set forth in the Company’s Form 10-K/A, filed with the SEC on February 28, 2025. Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively.

 

7

 

 

The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The CODM uses operating expenses to measure performance against progress in its clinical trials and its product development. The following table sets forth segment expenses.

 

(In thousands)                2025   2024 
  For the Three Months Ended
June 30,		    For the Six Months Ended
June 30,		 
(In thousands) 2025     2024   2025   2024 
Research and Development:                        
Employee expense $ 1,329     $ 1,211    $2,699   $2,364 
Clinical   960       1,198     1,832    2,657 
Product   403       273     548    576 
Other   199       143     369    280 
Total research and development   2,891       2,825     5,448    5,877 
Selling, General and Administrative Expense:                        
Employee expense   2,310       1,432     3,544    2,895 
Professional fees   308       517     888    932 
Reserve for uncollectible prepaid clinical costs   626       -     626    - 
Occupancy   151       156     314    309 
Insurance   157       164     320    329 
Other   606       360     863    615 
Total selling, general and administrative expense   4,158       2,629     6,555    5,080 
Loss from Operations   7,049       5,454     12,003    10,957 
Adjustments and reconciling items   (355 )     (498 )   (806)   (1,009)
Net Loss $ 6,694     $ 4,956    $11,197   $9,948 

 

Adjustments and reconciling items between loss from operations and net loss consist of interest income and realized and unrealized gains and losses related to the Company’s investments in US Treasury securities.

 

8

 

 

Item 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion should be read in conjunction with our unaudited condensed financial statements and notes thereto included herein. In connection with, and because we desire to take advantage of, the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, we caution readers regarding certain forward-looking statements in the following discussion and elsewhere in this Quarterly Report and in any other statement made by, or on our behalf, whether or not in future filings with the Securities and Exchange Commission. Forward-looking statements are statements not based on historical information and which relate to future operations, strategies, financial results or other developments. Such forward-looking statements involve significant risks and uncertainties. Forward looking statements are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our control and many of which, with respect to future business decisions, are subject to change. These uncertainties and contingencies can affect actual results and could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on our behalf. Words such as “anticipate,” “estimate,” “plan,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions are used to identify forward-looking statements. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

Unless the context requires otherwise, references in this document to “NVNO”, “we”, “our”, “us” or the “Company” are to enVVeno Medical Corporation

 

Overview

 

enVVeno Medical Corporation is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. Chronic Venous Disease (CVD) is the world’s most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S. Chronic Venous Insufficiency (CVI), is a large subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe CVI of the deep venous system of the leg.

 

The Company’s lead product is the VenoValve®, a potential first of its kind surgical replacement venous valve currently in post-enrollment follow-up of its U.S. pivotal study. The Company is also developing a second product called enVVe®, a potential next-generation, non-surgical, transcatheter based replacement venous valve. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

 

The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed approximately three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled “Risk Factors” in our Annual Report on Form 10-K/A, filed with the SEC on February 28, 2025). There are currently no devices FDA approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

 

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Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture our products in connection with our clinical trials in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.

 

CVI Background

 

Chronic venous disease (“CVD”) is the world’s most prevalent chronic disease. CVD is clinically classified using a standardized system known as CEAP (clinical, etiological, anatomical, and pathophysiological). The CEAP system consists of seven clinical classifications (C0 to C6) with C4, C5 and C6 being the most severe categories of CVD.

 

Chronic Venous Insufficiency (“CVI”) is a large subset of CVD and is generally used to describe patients with C4 to C6 CVD. CVI is a debilitating condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations.

 

The human leg contains three vein systems: the deep vein system, the superficial vein system, and the perforator vein system which connects the deep system to the superficial system. The deep venous system is located below the muscle and facia in the center portion of the leg and is responsible for approximately 90% of the blood flow. In order for blood to return to the heart from the foot, ankle, and lower leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves. Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve. CVI occurs when the one-way valves in the veins of the leg fail and become incompetent. When the valves fail, gravity causes the blood to flow backwards and in the wrong direction (reflux). As blood pools in the lower leg, pressure inside the veins increases (venous hypertension). Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases, venous ulcers.

 

Severe CVI sufferers experience a significantly reduced quality of life. Daily activities such as preparing meals, housework, and personal hygiene (washing and bathing) become difficult due to reduced mobility. For many severe CVI sufferers, intense pain, which frequently occurs at night, prevents them from getting adequate sleep. Severe CVI sufferers with venous leg ulcers (VLU) are known to miss approximately 40% more workdays than the average worker without the condition. A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge. Wound dressing changes, which occur several times a week, can be extremely painful. Venous ulcers from deep venous CVI are very difficult to heal, and a significant percentage of venous ulcers remain unhealed for more than a year. Even if healed, recurrence rates for venous ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years. Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation. As a result, studies have shown that patients with active venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%. Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe depressive symptoms.

 

Prevalence is generally defined as the portion of the population that has a given condition. Estimates indicate that the prevalence of people in the U.S. with severe, deep venous CVI (C4 to C6 disease) with reflux to be approximately 20 million. Incidence is generally defined as the number of new cases of an ailment that develop in a given time period. We estimate that approximately 3.5 million new patients with severe deep venous CVI are diagnosed each year in the U.S. including approximately 1.5 million patients that develop venous leg ulcers (C6 patients). The average patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous ulcer sufferers in the U.S. has been estimated to exceed $3 billion a year.

 

VenoValve

 

The VenoValve is a surgically implanted replacement venous valve developed by enVVeno Medical, designed for use in the deep veins of the leg to treat severe CVI caused by valvular incompetence. By lowering pressure (venous hypertension) within the deep venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal recurring venous leg ulcers. The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh. The surgical approach for implanting the VenoValve is referred to as the SAVVE® procedure, which enables physicians to implant the VenoValve to restore valve function in the deep veins of the leg. As our planned initial entrant to the replacement venous valve market, we estimate that approximately 2.5 million people each year with severe deep venous CVI in the U.S. would be candidates for the VenoValve, including approximately 1.5 million people with active venous ulcers. The VenoValve has been granted Breakthrough Device designation by the FDA.

 

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VenoValve Clinical Status

 

In March of 2021 we received IDE approval from the FDA to begin the VenoValve pivotal study. An investigational device exemption or IDE from the FDA is required before a medical device company can proceed with a pivotal trial for a Class III medical device. This approval allowed us to proceed with our U.S. pivotal study for the VenoValve, a prospective, non-blinded, single arm, multi-center clinical study. The seventy-five patient U.S. pivotal study reached full enrollment on September 1, 2023 and is now in the post-enrollment follow-up period.

 

The VenoValve is implanted using the SAVVE® procedure, an open surgical approach that enables precise placement of the device within the femoral vein to restore valve function. Efficacy endpoints for the U.S. pivotal study include rVCSS scores, which are used to provide evidence of clinically meaningful benefit, as well as reflux time measurements, VAS pain scores, quality of life measurements, ulcer healing (for CEAP class C6 patients), and intra-operative and one-year vein patency and valve functionality. Safety endpoints include device related events and procedure related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection and bleeding.

 

In November 2024, one year efficacy and safety data from the U.S. pivotal study was presented at the 51th Annual VEITH Symposium. The data indicated that eighty-five percent (85%) of the patients enrolled in the trial experienced a clinical meaningful benefit from the VenoValve, defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline. The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points. Patients in the study also experienced a seventy-five percent (75%) median reduction in pain and improvements in quality-of-life indicators. For patients with venous ulcers (CEAP C6 patients), ulcer area was reduced a median average of eighty-seven percent (87%). Over the course of the one (1) year period, there was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket hematomas, four (4) other bleeds, and seven (7) deep wound infections. Ninety-four percent (94%) of the patients that experienced a material safety event also went on to experience a clinically meaningful benefit from the VenoValve. Also, the reported target vein patency rates at thirty (30) days and one (1) year were ninety one percent (91%) and ninety seven percent (97%), respectively.

 

In June 2025, the Company announced that interim two-year follow-up data on forty-two (42) subjects from the seventy-five (75) patient VenoValve U.S. pivotal trial at the Society for Vascular Surgery 2025 Vascular Annual Meeting. The data indicated that eighty-three percent (83.3%) of patients enrolled in the trial (n=35/42) maintained a clinically meaningful benefit from the VenoValve, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS), at year two, compared to baseline. The average rVCSS improvement in the clinically meaningful responder cohort was 9.1 points. Patients in the study also experienced a seventy-four percent (74%) median reduction in leg pain, as measured by the Visual Analog Scale (VAS). For patients with venous ulcers, wound healing outcomes in seventeen (17) patients with twenty-five (25) ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym). Among the patients (n=30), a 100% valve patency rate was observed at the two-year follow up. All values were calculated comparing each patient’s baseline levels to the reported values at the patient’s 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases.

 

On November 19, 2024, the Company submitted the final module of its PMA application for review by the FDA. The VenoValve is designated as a breakthrough product and, as a result, its PMA application is subject to priority review. This may serve to shorten the PMA review process. Regardless, it is difficult to predict precisely how long the PMA process will take, and the Company’s best estimate is to expect an FDA decision during the second half of 2025.

 

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enVVe

 

On September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe®, for the treatment of CVI of the deep veins of the leg. Initial preliminary bench testing and pre-clinical testing for enVVe have been successfully completed.

 

On December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for enVVe. The first wave of implants, for the long-term subjects, was successfully completed in October 2024, and the final wave for the shorter-term subjects was completed in December 2024. The GLP study is a prerequisite to seeking IDE approval from the FDA to begin the enVVe U.S. pivotal study. The Company expects to file for IDE approval for the enVVe pivotal study in the third quarter of 2025.

 

Capital

 

We finished 2024 with approximately $43.2 million of cash and investments and had approximately $35.1 million of cash and investments as of June 30, 2025. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, related product development costs, and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per quarter as we conduct our clinical trials and work toward bringing our product candidates to market.

 

Results of Operations

 

Comparison of the three months ended June 30, 2025 and 2024

 

Overview

 

We reported net losses of $6.7 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.7 million, or 35%, due to an increase in operating expenses of $1.6 million and a decrease in other income of $0.1 million, as described in further detail below.

 

Revenues

 

As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate after receiving FDA approval, if ever.

 

Research and Development Expenses

 

For the three months ended June 30, 2025, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8 million for the three months ended June 30, 2024. This increase primarily resulted from $0.2 million in higher compensation costs from additional personnel, as well as higher professional fees, partially offset by $0.1 million in lower costs related the VenoValve pivotal study as the amount of follow-up for each participant decreases over time.

 

Selling, General and Administrative Expenses

 

For the three months ended June 30, 2025, selling, general and administrative expenses increased by $1.6 million or 58%, to $4.2 million from $2.6 million for the three months ended June 30, 2024. Of this increase, $0.4 million was due to compensation costs from the net effect of higher stock-based compensation from the issuance of additional option grants, a non-recurring severance expense of $0.3 million recorded in 2025, and $0.2 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required, and a net $0.1 million increase related to various other expenses.

 

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Other Income

 

For the three months ended June 30, 2025, other income decreased $0.1 million or 29% to $0.4 million from $0.5 million for the three months ended June 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in US Treasury bills.

 

Comparison of the six months ended June 30, 2025 and 2024

 

Overview

 

We reported net losses of $11.2 million and $10.0 million for the six months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.2 million or 13%, due to an increase in operating expenses of $1.0 million and a decrease in other income of $0.2 million, as described in further detail below.

 

Revenues

 

As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate after receiving FDA approval, if ever.

 

Research and Development Expenses

 

For the six months ended June 30, 2025, research and development expenses decreased by $0.5 million or 7%, to $5.4 million from $5.9 million for the six months ended June 30, 2024. This decrease primarily resulted from $0.9 million in lower costs related to the VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.4 million in higher compensation costs from additional personnel, as well as higher professional fees.

 

Selling, General and Administrative Expenses

 

For the six months ended June 30, 2025, selling, general and administrative expenses increased $1.5 million or 29%, to $6.6 million from $5.1 million for the six months ended June 30, 2024. Of this increase, $0.3 million was due to a non-recurring severance expense recorded in 2025 and $0.4 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required, and a net $0.2 million increase related to various other expenses.

 

Other (Income) Expense

 

For the six months ended June 30, 2025, other income decreased $0.2 million to $0.8 million from $1.0 million for the six months ended June 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in U.S. bills.

 

Liquidity and Capital Resources

 

For the six months ended June 30, 2025, the Company incurred losses from operations of $12.0 million and used $7.7 million cash in operating activities. The net cash used in operating activities during the 2025 period increased by $0.2 million from $7.5 million for the period ended June 30, 2024.

 

The losses and the uses of cash are primarily due to our product research and development activities, including clinical studies, and administrative activities. Research and development activities are for continued product development and clinical studies for our product candidates, currently the VenoValve and enVVe. Administrative functions relate to costs to support our public reporting and investor relations activities, internal administrative functions and, starting in 2024, costs to prepare for commercialization of the VenoValve. The Company will continue to incur these costs, and we anticipate these costs will increase, as we work to complete our clinical studies, enhance products, develop new products, bring those products to market, and operate as a public company.

 

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We are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product candidates after receiving FDA approval, if ever.

 

We do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue clinical studies, plan for commercialization of the VenoValve and continue development of enVVe.

 

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to between $5 million and $7 million per quarter as we conduct our clinical studies and work toward bringing our product candidates to market.

 

We have historically funded our operations through financing activities, such as the capital raise completed in 2024, and will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.

 

Based on our cash and working capital as of June 30, 2025, we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Quarterly Report and sustain operations.

 

Critical Accounting Estimates

 

The preparation of our consolidated financial statements requires management to make judgments, estimates and assumptions that affect the reported amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent liabilities, if any. Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in outcomes that require a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes differ from estimates.

 

We do not have any matters that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next fiscal year.

 

Off-Balance Sheet Arrangements

 

None.

 

Contractual Obligations

 

As a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.

 

Item 3. Quantitative and Qualitative Disclosure About Market Risk

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item.

 

Item 4: Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is our Principal Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting Officer), of the effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e) or 15d-15(e)) as of June 30, 2025, pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2025.

 

Changes in Internal Control over Financial Reporting

 

During the six months ended June 30, 2025, there were no changes in our internal controls over financial reporting, or in other factors that could significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Inherent Limitations of Controls

 

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. 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, within 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 a simple error or 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 the 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, controls may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

14

 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

None.

 

Item 1A. Risk Factors

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item. Our current risk factors are set forth in our Form 10-K/A, filed with the SEC on February 28, 2025.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults upon Senior Securities

 

None.

 

Item 4. Mine and Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

Reference is made to our Current Report on Form 8-K filed on May 20, 2025 reporting the appointment of Jennifer Bright as Chief Financial Officer of the Company. Attached hereto as Exhibit 10.1 and Exhibit 99.1 are the employment agreement, dated May 19, 2025, between the Company and Ms. Bright and the Officer Indemnity Agreement entered into by and between the Company and Ms. Bright.

 

Trading Arrangements

 

On June 12, 2025, Dr. Francis Duhay, a director of the Company, adopted a “Rule 10b5-1 trading arrangement” (as defined in Item 408 of Regulation S-K of the Exchange Act) (with the first trade under the new plan not to be made prior to September 15, 2025). The trading plan will be effective until September 30, 2026 and provides for the sale of 20,000 shares of common stock.

 

15

 

 

Item 6. Exhibits

 

The following is a complete list of exhibits filed as part of this Form 10-Q. Exhibit numbers correspond to the numbers in the Exhibit Table of Item 601 of Regulation S-K.

 

Exhibit   Description
10.1   Employment Agreement, dated as of May 19, 2025, by and between enVVeno Medical Corporation and Jennifer Bright*
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act*
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Sarbanes-Oxley Act*
32   Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act**
99.1   Officer Indemnity Agreement, dated July 26, 2025, by and between enVVeno Medical Corporation and Jennifer Bright*
101.INS   Inline XBRL Instance Document*
101.SCH   Inline XBRL Taxonomy Extension Schema Document*
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith.
** These certifications are furnished to the SEC pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

 

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SIGNATURES

 

Pursuant to the requirements of Section 12 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.

 

Date: July 31, 2025 ENVVENO MEDICAL CORPORATION
     
  By: /s/ Robert Berman
    Robert Berman
    Chief Executive Officer
    (Principal Executive Officer)
     
  By: /s/ Jennifer Bright
    Jennifer Bright
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

17

 

Source: View Original Filing on SEC EDGAR

FAQ

What was enVVeno Medical’s (NVNO) net loss for Q2 2025?

The company reported a net loss of $6.7 million, or $0.33 per share, for the quarter ended June 30 2025.

How much cash does NVNO have and how long will it last?

Cash and short-term investments totaled $35.1 million on June 30 2025, which management believes funds operations for at least the next 12 months.

What is the status of the VenoValve FDA approval process?

NVNO submitted the final PMA module in November 2024; with breakthrough priority review, an FDA decision is expected in the second half of 2025.

What were the key two-year clinical results for VenoValve?

Interim data showed 83 % of patients retained ≥3-point rVCSS improvement, 74 % median pain reduction, and 100 % valve patency (n=30).

When will the enVVe transcatheter valve enter pivotal trials?

The company plans to file an IDE in Q3 2025; pivotal study timing depends on FDA clearance.

Did operating expenses change significantly year-over-year?

Yes. SG&A rose 58 % YoY to $4.2 million due to stock compensation, severance, and a reserve for uncollectible prepaid clinical costs.
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Envveno Medical Corporation

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Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
May 19, 2025
enVVeno Medical Appoints Jennifer Bright as Chief Financial Officer
May 13, 2025
Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery

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