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STOCK TITAN

[8-K] Tivic Health Systems, Inc. Reports Material Event

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

Tectonic Therapeutic, Inc. (Nasdaq: TECX) has filed a Form S-3 shelf registration that allows the company to issue up to $400 million of common stock, preferred stock, debt securities and/or warrants. The filing also includes a dedicated $100 million at-the-market (ATM) sales agreement with TD Securities (USA) LLC, giving management flexibility to raise capital "from time to time" as clinical milestones approach.

The prospectus reiterates Tectonic’s strategy of developing biologics that modulate GPCRs via its proprietary GEODeâ„� platform. Lead asset TX45 (Fc-relaxin fusion) has completed a Phase 1a study showing good tolerability and a favourable PK/PD profile. In Part A of an ongoing Phase 1b hemodynamic trial in PH-HFpEF patients, TX45 achieved a 19% reduction in pulmonary capillary wedge pressure and a >30% PVR reduction in a severe sub-population, with no serious adverse events. Recruitment is under way for Part B (PH-HFrEF), and the 24-week placebo-controlled Phase 2 APEX trial dosed its first patient in October 2024; topline data are expected in 2026.

Second program TX2100, a VHH-Fc fusion for Hereditary Hemorrhagic Telangiectasia, entered IND-enabling studies in Q2 2025, with a Phase 1 start targeted for late 2025/early 2026. The company completed a reverse-merger with Legacy Tectonic in June 2024 and now qualifies as a smaller reporting company. Proceeds from any sales under the shelf will fund pipeline advancement, working capital and potential in-licensing.

As of 3 July 2025 the stock traded at $21.34 per share. While the registration itself is not a financing event, it signals possible future dilution balanced by improved funding optionality ahead of multiple clinical catalysts.

Tectonic Therapeutic, Inc. (Nasdaq: TECX) ha depositato una registrazione Form S-3 che consente all'azienda di emettere fino a 400 milioni di dollari in azioni ordinarie, azioni privilegiate, titoli di debito e/o warrant. La registrazione include anche un accordo di vendita at-the-market (ATM) dedicato da 100 milioni di dollari con TD Securities (USA) LLC, offrendo alla direzione la flessibilità di raccogliere capitali "di volta in volta" in prossimità dei traguardi clinici.

Il prospetto ribadisce la strategia di Tectonic di sviluppare biologici che modulano i GPCR attraverso la sua piattaforma proprietaria GEODe�. Il candidato principale, TX45 (fusione Fc-relaxina), ha completato uno studio di Fase 1a dimostrando buona tollerabilità e un profilo PK/PD favorevole. Nella Parte A di uno studio emodinamico di Fase 1b in pazienti con PH-HFpEF, TX45 ha ottenuto una riduzione del 19% della pressione capillare polmonare a cuneo e una riduzione >30% della PVR in una sottopopolazione grave, senza eventi avversi seri. È in corso il reclutamento per la Parte B (PH-HFrEF), e lo studio controllato con placebo di Fase 2 APEX di 24 settimane ha dosato il primo paziente a ottobre 2024; i dati principali sono attesi nel 2026.

Il secondo programma, TX2100, una fusione VHH-Fc per la Telangiectasia Emorragica Ereditaria, è entrato negli studi abilitanti IND nel secondo trimestre 2025, con inizio della Fase 1 previsto per fine 2025/inizi 2026. La società ha completato una fusione inversa con Legacy Tectonic a giugno 2024 e ora rientra nella categoria di smaller reporting company. I proventi derivanti da eventuali vendite nell’ambito della registrazione finanzieranno l’avanzamento della pipeline, il capitale circolante e potenziali licenze in ingresso.

Al 3 luglio 2025 il titolo quotava a 21,34 dollari per azione. Sebbene la registrazione non costituisca un evento di finanziamento, segnala una possibile diluizione futura bilanciata da una maggiore flessibilità finanziaria in vista di molteplici catalizzatori clinici.

Tectonic Therapeutic, Inc. (Nasdaq: TECX) ha presentado un registro Form S-3 que permite a la compañía emitir hasta 400 millones de dólares en acciones comunes, acciones preferentes, valores de deuda y/o warrants. La presentación también incluye un acuerdo de ventas at-the-market (ATM) dedicado de 100 millones de dólares con TD Securities (USA) LLC, brindando a la dirección flexibilidad para recaudar capital "de vez en cuando" conforme se acercan los hitos clínicos.

El prospecto reafirma la estrategia de Tectonic de desarrollar biológicos que modulan los GPCR mediante su plataforma propietaria GEODe�. El activo principal, TX45 (fusión Fc-relaxina), completó un estudio de Fase 1a mostrando buena tolerabilidad y un perfil PK/PD favorable. En la Parte A de un ensayo hemodinámico de Fase 1b en pacientes con PH-HFpEF, TX45 logró una reducción del 19% en la presión capilar pulmonar en cuña y una reducción >30% en la resistencia vascular pulmonar (PVR) en una subpoblación severa, sin eventos adversos graves. Está en marcha el reclutamiento para la Parte B (PH-HFrEF), y el ensayo controlado con placebo de Fase 2 APEX de 24 semanas dosificó a su primer paciente en octubre de 2024; se esperan datos principales en 2026.

El segundo programa, TX2100, una fusión VHH-Fc para la Telangiectasia Hemorrágica Hereditaria, inició estudios para la habilitación IND en el segundo trimestre de 2025, con inicio de Fase 1 previsto para finales de 2025/principios de 2026. La compañía completó una fusión inversa con Legacy Tectonic en junio de 2024 y ahora califica como una smaller reporting company. Los ingresos de cualquier venta bajo el registro financiarán el avance de la cartera, capital de trabajo y posibles licencias entrantes.

Al 3 de julio de 2025, la acción cotizaba a 21,34 dólares por acción. Aunque el registro en sí no es un evento de financiamiento, indica una posible dilución futura equilibrada con una mejor opción de financiamiento ante múltiples catalizadores clínicos.

Tectonic Therapeutic, Inc. (나스ë‹�: TECX)ëŠ� 최대 4ì–� 달러 규모ì� 보통ì£�, ìš°ì„ ì£�, 채무 ì¦ê¶Œ ë°�/ë˜ëŠ” 워런트를 발행í•� ìˆ� 있는 Form S-3 ì„ ë°˜ 등ë¡ì� 제출했습니다. ì� 등ë¡ì—는 TD Securities (USA) LLC와ì� ì „ìš© 1ì–� 달러 규모ì� ATM(시장가ê²� 매출) íŒë§¤ 계약ë� í¬í•¨ë˜ì–´ 있어 ìž„ìƒ ì´ì •표가 다가ì˜� 때마ë‹� ìžë³¸ 조달ì—� ìœ ì—°ì„±ì„ ì œê³µí•©ë‹ˆë‹�.

설명서ì—ëŠ� Tectonicì� ë…ìžì ì¸ GEODeâ„� 플랫í¼ì„ 통해 GPCRì� 조절하는 ìƒë¬¼í•™ì  제제ë¥� 개발하는 ì „ëžµì� 다시 í•� ë²� ê°•ì¡°ë˜ì–´ 있습니다. 주요 ìžì‚°ì� TX45(Fc-릴렉ì‹� 융합ì²�)ëŠ� ë‚´ì•½ì„±ì´ ìš°ìˆ˜í•˜ê³  PK/PD 프로파ì¼ì� 양호í•� 1aìƒ� 시험ì� 완료했습니다. ì§„í–‰ ì¤‘ì¸ PH-HFpEF í™˜ìž ëŒ€ìƒ� 1bìƒ� 혈류역학 시험ì� Aë¶€ì—서 TX45ëŠ� í모세혈관 ìê¸°ì••ì„ 19% ê°ì†Œì‹œí‚¤ê³� ì¤‘ì¦ í•˜ìœ„êµ°ì—ì„� PVRì� 30% ì´ìƒ ê°ì†Œì‹œì¼°ìœ¼ë©° 심ê°í•� ë¶€ìž‘ìš©ì€ ì—†ì—ˆìŠµë‹ˆë‹�. Bë¶€(PH-HFrEF) 모집ì� ì§„í–‰ 중ì´ë©�, 24주간 위약 대ì¡� 2ìƒ� APEX ì‹œí—˜ì€ 2024ë…� 10ì›� ì²� í™˜ìž íˆ¬ì—¬ë¥� 완료했으ë©�, 주요 ê²°ê³¼ëŠ� 2026ë…„ì— ë‚˜ì˜¬ 예정입니ë‹�.

ë‘� 번째 프로그램ì� TX2100ì€ ìœ ì „ì„� 출혈ì„� 모세혈관확장ì¦ì„ 위한 VHH-Fc 융합체로 2025ë…� 2분기ì—� IND ìŠ¹ì¸ ì¤€ë¹� 연구ì—� 들어갔으ë©�, 2025ë…� ë§~2026ë…� ì´ˆì— 1ìƒ� 시험 시작ì� 목표ë¡� 하고 있습니다. 회사ëŠ� 2024ë…� 6ì›� Legacy Tectonicê³� ì—­í•©ë³‘ì„ ì™„ë£Œí–ˆìœ¼ë©� 현재 소규ëª� ë³´ê³  회사 ìžê²©ì� ê°–ì¶”ê³� 있습니다. ì„ ë°˜ 등ë¡ì—� 따른 매출 수ìµì€ 파ì´í”„ë¼ì� 개발, ìš´ì „ìžë³¸ ë°� 잠재ì � ë¼ì´ì„ ìФ ë„ìž…ì—� 사용ë� 예정입니ë‹�.

2025ë…� 7ì›� 3ì� 기준 주가ëŠ� 주당 21.34달러ì—� 거래ë˜ì—ˆìŠµë‹ˆë‹�. ë“±ë¡ ìžì²´ëŠ� ìžê¸ˆ 조달 ì´ë²¤íŠ¸ëŠ” 아니지ë§�, 다수ì� ìž„ìƒ ì´‰ë§¤ì œë¥¼ 앞ë‘ê³� ìžê¸ˆ 조달 ì„ íƒê¶Œì´ 개선ë˜ëŠ” ë™ì‹œì—� 미래 í¬ì„ 가능성ì� 시사합니ë‹�.

Tectonic Therapeutic, Inc. (Nasdaq : TECX) a déposé un enregistrement de type Form S-3 permettant à la société d’émettre jusqu’� 400 millions de dollars d’actions ordinaires, d’actions privilégiées, de titres de dette et/ou de bons de souscription. Le dépôt comprend également un accord de vente at-the-market (ATM) dédié de 100 millions de dollars avec TD Securities (USA) LLC, offrant à la direction la flexibilité de lever des fonds "de temps à autre" à l’approche des jalons cliniques.

Le prospectus réaffirme la stratégie de Tectonic visant à développer des produits biologiques modulant les GPCR via sa plateforme propriétaire GEODe�. Le principal actif, TX45 (fusion Fc-relaxine), a achevé une étude de Phase 1a montrant une bonne tolérance et un profil PK/PD favorable. Dans la Partie A d’un essai hémodynamique de Phase 1b en cours chez des patients PH-HFpEF, TX45 a obtenu une réduction de 19 % de la pression capillaire pulmonaire en coin et une réduction >30 % de la RVP dans une sous-population sévère, sans événement indésirable grave. Le recrutement est en cours pour la Partie B (PH-HFrEF), et l’essai contrôlé par placebo de Phase 2 APEX de 24 semaines a traité son premier patient en octobre 2024 ; les données principales sont attendues en 2026.

Le second programme, TX2100, une fusion VHH-Fc pour la télangiectasie hémorragique héréditaire, a entamé des études préparatoires IND au T2 2025, avec un démarrage de Phase 1 prévu fin 2025/début 2026. La société a finalisé une fusion inversée avec Legacy Tectonic en juin 2024 et est désormais qualifiée de smaller reporting company. Les fonds issus de toute vente sous l’enregistrement serviront à faire progresser le pipeline, au fonds de roulement et à d’éventuelles licences entrantes.

Au 3 juillet 2025, l’action se négociait à 21,34 dollars par action. Bien que l’enregistrement ne constitue pas un événement de financement, il annonce une possible dilution future compensée par une meilleure flexibilité financière avant plusieurs catalyseurs cliniques.

Tectonic Therapeutic, Inc. (Nasdaq: TECX) hat eine Form S-3 Shelf-Registrierung eingereicht, die dem Unternehmen erlaubt, bis zu 400 Millionen US-Dollar an Stammaktien, Vorzugsaktien, Schuldverschreibungen und/oder Warrants auszugeben. Die Einreichung beinhaltet auch eine dedizierte 100-Millionen-Dollar At-the-Market (ATM) Verkaufsvereinbarung mit TD Securities (USA) LLC, die der Geschäftsleitung Flexibilität gibt, "von Zeit zu Zeit" Kapital zu beschaffen, wenn klinische Meilensteine näher rücken.

Der Prospekt bekräftigt Tectonics Strategie, Biologika zu entwickeln, die GPCRs über die firmeneigene GEODe� Plattform modulieren. Das Leitprodukt TX45 (Fc-Relaxin-Fusion) hat eine Phase-1a-Studie mit guter Verträglichkeit und einem günstigen PK/PD-Profil abgeschlossen. In Teil A einer laufenden Phase-1b-hemodynamischen Studie bei PH-HFpEF-Patienten erzielte TX45 eine 19%ige Reduktion des pulmonalen Kapillarkeildrucks und eine >30%ige Senkung des PVR in einer schweren Subpopulation, ohne schwerwiegende Nebenwirkungen. Die Rekrutierung für Teil B (PH-HFrEF) läuft, und die 24-wöchige placebokontrollierte Phase-2-APEX-Studie dosierte ihren ersten Patienten im Oktober 2024; Topline-Daten werden 2026 erwartet.

Das zweite Programm, TX2100, eine VHH-Fc-Fusion für hereditäre hämorrhagische Teleangiektasie, begann im 2. Quartal 2025 mit IND-erlaubenden Studien, mit einem Zielstart der Phase 1 Ende 2025/Anfang 2026. Das Unternehmen schloss im Juni 2024 eine Reverse-Merger mit Legacy Tectonic ab und qualifiziert sich nun als smaller reporting company. Erlöse aus Verkäufen unter der Shelf-Registrierung werden zur Pipeline-Weiterentwicklung, Betriebskapital und potenziellen In-Lizenzierungen verwendet.

Am 3. Juli 2025 wurde die Aktie zu 21,34 US-Dollar pro Aktie gehandelt. Obwohl die Registrierung selbst kein Finanzierungsereignis darstellt, signalisiert sie eine mögliche zukünftige Verwässerung, die durch verbesserte Finanzierungsmöglichkeiten vor mehreren klinischen Katalysatoren ausgeglichen wird.

Positive
  • None.
Negative
  • None.

Insights

TL;DR: $400 M shelf plus $100 M ATM strengthen liquidity options before Phase 2 data; dilution risk offsets financing flexibility—net neutral.

Impact assessment: The universal shelf is impactful because it pre-positions management to access meaningful capital for the costly APEX Phase 2 and upcoming TX2100 trials. However, no securities are being sold today, and utilisation will depend on market conditions. Investors should weigh:

  • Positive: Additional runway could support pivotal-enabling data without a larger, more dilutive follow-on.
  • Negative: The authorised amount (~19% of current market cap at $21.34) implies potential dilution if fully issued.

Valuation view: Shelf filings are standard for pre-commercial biotechs; I view the news as neutral (rating 0) with upside tied to forthcoming clinical read-outs rather than the registration itself.

Tectonic Therapeutic, Inc. (Nasdaq: TECX) ha depositato una registrazione Form S-3 che consente all'azienda di emettere fino a 400 milioni di dollari in azioni ordinarie, azioni privilegiate, titoli di debito e/o warrant. La registrazione include anche un accordo di vendita at-the-market (ATM) dedicato da 100 milioni di dollari con TD Securities (USA) LLC, offrendo alla direzione la flessibilità di raccogliere capitali "di volta in volta" in prossimità dei traguardi clinici.

Il prospetto ribadisce la strategia di Tectonic di sviluppare biologici che modulano i GPCR attraverso la sua piattaforma proprietaria GEODe�. Il candidato principale, TX45 (fusione Fc-relaxina), ha completato uno studio di Fase 1a dimostrando buona tollerabilità e un profilo PK/PD favorevole. Nella Parte A di uno studio emodinamico di Fase 1b in pazienti con PH-HFpEF, TX45 ha ottenuto una riduzione del 19% della pressione capillare polmonare a cuneo e una riduzione >30% della PVR in una sottopopolazione grave, senza eventi avversi seri. È in corso il reclutamento per la Parte B (PH-HFrEF), e lo studio controllato con placebo di Fase 2 APEX di 24 settimane ha dosato il primo paziente a ottobre 2024; i dati principali sono attesi nel 2026.

Il secondo programma, TX2100, una fusione VHH-Fc per la Telangiectasia Emorragica Ereditaria, è entrato negli studi abilitanti IND nel secondo trimestre 2025, con inizio della Fase 1 previsto per fine 2025/inizi 2026. La società ha completato una fusione inversa con Legacy Tectonic a giugno 2024 e ora rientra nella categoria di smaller reporting company. I proventi derivanti da eventuali vendite nell’ambito della registrazione finanzieranno l’avanzamento della pipeline, il capitale circolante e potenziali licenze in ingresso.

Al 3 luglio 2025 il titolo quotava a 21,34 dollari per azione. Sebbene la registrazione non costituisca un evento di finanziamento, segnala una possibile diluizione futura bilanciata da una maggiore flessibilità finanziaria in vista di molteplici catalizzatori clinici.

Tectonic Therapeutic, Inc. (Nasdaq: TECX) ha presentado un registro Form S-3 que permite a la compañía emitir hasta 400 millones de dólares en acciones comunes, acciones preferentes, valores de deuda y/o warrants. La presentación también incluye un acuerdo de ventas at-the-market (ATM) dedicado de 100 millones de dólares con TD Securities (USA) LLC, brindando a la dirección flexibilidad para recaudar capital "de vez en cuando" conforme se acercan los hitos clínicos.

El prospecto reafirma la estrategia de Tectonic de desarrollar biológicos que modulan los GPCR mediante su plataforma propietaria GEODe�. El activo principal, TX45 (fusión Fc-relaxina), completó un estudio de Fase 1a mostrando buena tolerabilidad y un perfil PK/PD favorable. En la Parte A de un ensayo hemodinámico de Fase 1b en pacientes con PH-HFpEF, TX45 logró una reducción del 19% en la presión capilar pulmonar en cuña y una reducción >30% en la resistencia vascular pulmonar (PVR) en una subpoblación severa, sin eventos adversos graves. Está en marcha el reclutamiento para la Parte B (PH-HFrEF), y el ensayo controlado con placebo de Fase 2 APEX de 24 semanas dosificó a su primer paciente en octubre de 2024; se esperan datos principales en 2026.

El segundo programa, TX2100, una fusión VHH-Fc para la Telangiectasia Hemorrágica Hereditaria, inició estudios para la habilitación IND en el segundo trimestre de 2025, con inicio de Fase 1 previsto para finales de 2025/principios de 2026. La compañía completó una fusión inversa con Legacy Tectonic en junio de 2024 y ahora califica como una smaller reporting company. Los ingresos de cualquier venta bajo el registro financiarán el avance de la cartera, capital de trabajo y posibles licencias entrantes.

Al 3 de julio de 2025, la acción cotizaba a 21,34 dólares por acción. Aunque el registro en sí no es un evento de financiamiento, indica una posible dilución futura equilibrada con una mejor opción de financiamiento ante múltiples catalizadores clínicos.

Tectonic Therapeutic, Inc. (나스ë‹�: TECX)ëŠ� 최대 4ì–� 달러 규모ì� 보통ì£�, ìš°ì„ ì£�, 채무 ì¦ê¶Œ ë°�/ë˜ëŠ” 워런트를 발행í•� ìˆ� 있는 Form S-3 ì„ ë°˜ 등ë¡ì� 제출했습니다. ì� 등ë¡ì—는 TD Securities (USA) LLC와ì� ì „ìš© 1ì–� 달러 규모ì� ATM(시장가ê²� 매출) íŒë§¤ 계약ë� í¬í•¨ë˜ì–´ 있어 ìž„ìƒ ì´ì •표가 다가ì˜� 때마ë‹� ìžë³¸ 조달ì—� ìœ ì—°ì„±ì„ ì œê³µí•©ë‹ˆë‹�.

설명서ì—ëŠ� Tectonicì� ë…ìžì ì¸ GEODeâ„� 플랫í¼ì„ 통해 GPCRì� 조절하는 ìƒë¬¼í•™ì  제제ë¥� 개발하는 ì „ëžµì� 다시 í•� ë²� ê°•ì¡°ë˜ì–´ 있습니다. 주요 ìžì‚°ì� TX45(Fc-릴렉ì‹� 융합ì²�)ëŠ� ë‚´ì•½ì„±ì´ ìš°ìˆ˜í•˜ê³  PK/PD 프로파ì¼ì� 양호í•� 1aìƒ� 시험ì� 완료했습니다. ì§„í–‰ ì¤‘ì¸ PH-HFpEF í™˜ìž ëŒ€ìƒ� 1bìƒ� 혈류역학 시험ì� Aë¶€ì—서 TX45ëŠ� í모세혈관 ìê¸°ì••ì„ 19% ê°ì†Œì‹œí‚¤ê³� ì¤‘ì¦ í•˜ìœ„êµ°ì—ì„� PVRì� 30% ì´ìƒ ê°ì†Œì‹œì¼°ìœ¼ë©° 심ê°í•� ë¶€ìž‘ìš©ì€ ì—†ì—ˆìŠµë‹ˆë‹�. Bë¶€(PH-HFrEF) 모집ì� ì§„í–‰ 중ì´ë©�, 24주간 위약 대ì¡� 2ìƒ� APEX ì‹œí—˜ì€ 2024ë…� 10ì›� ì²� í™˜ìž íˆ¬ì—¬ë¥� 완료했으ë©�, 주요 ê²°ê³¼ëŠ� 2026ë…„ì— ë‚˜ì˜¬ 예정입니ë‹�.

ë‘� 번째 프로그램ì� TX2100ì€ ìœ ì „ì„� 출혈ì„� 모세혈관확장ì¦ì„ 위한 VHH-Fc 융합체로 2025ë…� 2분기ì—� IND ìŠ¹ì¸ ì¤€ë¹� 연구ì—� 들어갔으ë©�, 2025ë…� ë§~2026ë…� ì´ˆì— 1ìƒ� 시험 시작ì� 목표ë¡� 하고 있습니다. 회사ëŠ� 2024ë…� 6ì›� Legacy Tectonicê³� ì—­í•©ë³‘ì„ ì™„ë£Œí–ˆìœ¼ë©� 현재 소규ëª� ë³´ê³  회사 ìžê²©ì� ê°–ì¶”ê³� 있습니다. ì„ ë°˜ 등ë¡ì—� 따른 매출 수ìµì€ 파ì´í”„ë¼ì� 개발, ìš´ì „ìžë³¸ ë°� 잠재ì � ë¼ì´ì„ ìФ ë„ìž…ì—� 사용ë� 예정입니ë‹�.

2025ë…� 7ì›� 3ì� 기준 주가ëŠ� 주당 21.34달러ì—� 거래ë˜ì—ˆìŠµë‹ˆë‹�. ë“±ë¡ ìžì²´ëŠ� ìžê¸ˆ 조달 ì´ë²¤íŠ¸ëŠ” 아니지ë§�, 다수ì� ìž„ìƒ ì´‰ë§¤ì œë¥¼ 앞ë‘ê³� ìžê¸ˆ 조달 ì„ íƒê¶Œì´ 개선ë˜ëŠ” ë™ì‹œì—� 미래 í¬ì„ 가능성ì� 시사합니ë‹�.

Tectonic Therapeutic, Inc. (Nasdaq : TECX) a déposé un enregistrement de type Form S-3 permettant à la société d’émettre jusqu’� 400 millions de dollars d’actions ordinaires, d’actions privilégiées, de titres de dette et/ou de bons de souscription. Le dépôt comprend également un accord de vente at-the-market (ATM) dédié de 100 millions de dollars avec TD Securities (USA) LLC, offrant à la direction la flexibilité de lever des fonds "de temps à autre" à l’approche des jalons cliniques.

Le prospectus réaffirme la stratégie de Tectonic visant à développer des produits biologiques modulant les GPCR via sa plateforme propriétaire GEODe�. Le principal actif, TX45 (fusion Fc-relaxine), a achevé une étude de Phase 1a montrant une bonne tolérance et un profil PK/PD favorable. Dans la Partie A d’un essai hémodynamique de Phase 1b en cours chez des patients PH-HFpEF, TX45 a obtenu une réduction de 19 % de la pression capillaire pulmonaire en coin et une réduction >30 % de la RVP dans une sous-population sévère, sans événement indésirable grave. Le recrutement est en cours pour la Partie B (PH-HFrEF), et l’essai contrôlé par placebo de Phase 2 APEX de 24 semaines a traité son premier patient en octobre 2024 ; les données principales sont attendues en 2026.

Le second programme, TX2100, une fusion VHH-Fc pour la télangiectasie hémorragique héréditaire, a entamé des études préparatoires IND au T2 2025, avec un démarrage de Phase 1 prévu fin 2025/début 2026. La société a finalisé une fusion inversée avec Legacy Tectonic en juin 2024 et est désormais qualifiée de smaller reporting company. Les fonds issus de toute vente sous l’enregistrement serviront à faire progresser le pipeline, au fonds de roulement et à d’éventuelles licences entrantes.

Au 3 juillet 2025, l’action se négociait à 21,34 dollars par action. Bien que l’enregistrement ne constitue pas un événement de financement, il annonce une possible dilution future compensée par une meilleure flexibilité financière avant plusieurs catalyseurs cliniques.

Tectonic Therapeutic, Inc. (Nasdaq: TECX) hat eine Form S-3 Shelf-Registrierung eingereicht, die dem Unternehmen erlaubt, bis zu 400 Millionen US-Dollar an Stammaktien, Vorzugsaktien, Schuldverschreibungen und/oder Warrants auszugeben. Die Einreichung beinhaltet auch eine dedizierte 100-Millionen-Dollar At-the-Market (ATM) Verkaufsvereinbarung mit TD Securities (USA) LLC, die der Geschäftsleitung Flexibilität gibt, "von Zeit zu Zeit" Kapital zu beschaffen, wenn klinische Meilensteine näher rücken.

Der Prospekt bekräftigt Tectonics Strategie, Biologika zu entwickeln, die GPCRs über die firmeneigene GEODe� Plattform modulieren. Das Leitprodukt TX45 (Fc-Relaxin-Fusion) hat eine Phase-1a-Studie mit guter Verträglichkeit und einem günstigen PK/PD-Profil abgeschlossen. In Teil A einer laufenden Phase-1b-hemodynamischen Studie bei PH-HFpEF-Patienten erzielte TX45 eine 19%ige Reduktion des pulmonalen Kapillarkeildrucks und eine >30%ige Senkung des PVR in einer schweren Subpopulation, ohne schwerwiegende Nebenwirkungen. Die Rekrutierung für Teil B (PH-HFrEF) läuft, und die 24-wöchige placebokontrollierte Phase-2-APEX-Studie dosierte ihren ersten Patienten im Oktober 2024; Topline-Daten werden 2026 erwartet.

Das zweite Programm, TX2100, eine VHH-Fc-Fusion für hereditäre hämorrhagische Teleangiektasie, begann im 2. Quartal 2025 mit IND-erlaubenden Studien, mit einem Zielstart der Phase 1 Ende 2025/Anfang 2026. Das Unternehmen schloss im Juni 2024 eine Reverse-Merger mit Legacy Tectonic ab und qualifiziert sich nun als smaller reporting company. Erlöse aus Verkäufen unter der Shelf-Registrierung werden zur Pipeline-Weiterentwicklung, Betriebskapital und potenziellen In-Lizenzierungen verwendet.

Am 3. Juli 2025 wurde die Aktie zu 21,34 US-Dollar pro Aktie gehandelt. Obwohl die Registrierung selbst kein Finanzierungsereignis darstellt, signalisiert sie eine mögliche zukünftige Verwässerung, die durch verbesserte Finanzierungsmöglichkeiten vor mehreren klinischen Katalysatoren ausgeglichen wird.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 30, 2025

 

 

Tivic Health Systems, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-41052

81-4016391

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

47685 Lakeview Blvd.

 

Fremont, California

 

94538

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 888 276-6888

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

TIVC

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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.

 


Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Lisa Wolf as Permanent Chief Financial Officer

On July 3, 2025, the board of directors (the “Board”) of Tivic Health Systems, Inc. (the “Company”) appointed Lisa Wolf to serve as the Company’s permanent Chief Financial Officer, effective July 7, 2025. She has been serving as the Company’s Interim Chief Financial Officer as a non-employee consultant since October 2024, prior to which she played a key role in supporting the Company’s accounting and Securities and Exchange Commission reporting functions on an out-sourced basis since June 2022. In connection with her appointment as permanent Chief Financial Officer of the Company, Ms. Wolf will become an employee of the Company and will no longer continue to serve as a consultant.

In connection with Ms. Wolf’s appointment as permanent Chief Financial Officer, on July 4, 2025, the Company and Ms. Wolf entered into an executive employment agreement (the “Wolf Employment Agreement”), which has an effective date of July 7, 2025. Pursuant to the Wolf Employment Agreement, Ms. Wolf (i) is entitled to receive a base salary of $240,000 per annum (subject to review and adjustment in accordance with the Company’s normal performance review practices); (ii) will be eligible to receive, at the sole discretion of the Board, an annual end-of-year incentive bonus in an amount up to 35% of her base salary; and (iii) may be eligible to receive annual focal grants, as determined by the Board or the Compensation Committee of the Board, pursuant to the Company’s Amended and Restated 2021 Equity Incentive Plan (the “2021 Plan”). Additionally, the Company’s Chief Executive Officer shall recommend to the Board, at the next meeting thereof, that the Board grant Ms. Wolf an equity incentive award, in line with similarly situated executives of the Company, in connection with her appointment as permanent Chief Financial Officer.

Pursuant to the Wolf Employment Agreement, Ms. Wolf’s employment is “at will,” meaning that either she or the Company are entitled to terminate Ms. Wolf’s employment at any time and for any reason, with or without cause. In the event that her employment with the Company is terminated for any reason before December 31 of any given year, she will not be entitled to receive an annual end-of-year incentive bonus. In the event that (i) Ms. Wolf elects to terminate her employment with the Company other than for good reason, (ii) the Company terminates her employment for cause, or (iii) her employment is terminated as a result of her death or disability, then Ms. Wolf will not be entitled to receive any separation benefits. In the event that Ms. Wolf terminates her employment for good reason or the Company terminates her employment without cause, then she shall be entitled to receive severance in an amount equal to 1/12 of her base salary for a period of six months after termination, payable in accordance with the Company’s standard payroll procedures, and the Company shall pay her COBRA coverage for a period of six months after termination.

The foregoing summary of the Wolf Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Wolf Employment Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.

There is no arrangement or understanding between Ms. Wolf and any other person pursuant to which Ms. Wolf was appointed as the permanent Chief Financial Officer of the Company. There are no family relationships between Ms. Wolf and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive officer. Ms. Wolf has not engaged in any related-person transactions required to be disclosed by Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended.

Transition of Blake Gurfein from Chief Scientific Officer to Consultant

On June 30, 2025, Blake Gurfein notified the Company of his decision to step down as Chief Scientific Officer of the Company, effective July 4, 2025, to pursue other opportunities. Commencing July 4, 2025, and for a period of no less than six months (subject to certain limitations), Dr. Gurfein will continue to provide part-time services to the Company as a consultant and will aid in the further development of the Company’s vagus nerve stimulation program. During the term of his consultancy, he will be entitled to receive $20,000 per month as compensation for services rendered to the Company.

Dr. Gurfein’s decision to step down was not based on any disagreement with the Company on any matter relating to its operations, policies or practices.

As a result of Dr. Gurfein’s transition from Chief Scientific Officer to a consultant, that offer letter entered into by and between the Company and Dr. Gurfein in 2018, as amended, terminated effective July 4, 2025. In connection with the termination of his employment, subject to his execution and non-revocation of a waiver and release of claims agreement, (i) Dr. Gurfein will be entitled to receive a lump sum cash payment of $45,938, less standard deductions; (ii) he will have the right to continue his medical, dental or vision benefits, at his sole expense, should he timely elect COBRA coverage; and (iii) his outstanding unvested equity awards granted under the 2021 Plan or the Company’s predecessor equity incentive plan will continue to vest for so long as he continues to provide services to the Company as a consultant.

Amendment to the Company’s Amended and Restated 2021 Equity Incentive Plan


As described in Item 5.07 below, on June 30, 2025, at the Company’s 2025 Annual Meeting of Stockholders (the “Annual Meeting”), the Company’s stockholders approved an amendment (the “Plan Amendment”) to the Company’s 2021 Plan to increase the number of shares of common stock authorized for issuance thereunder by 425,000 shares. The Plan Amendment was previously approved by the Board, subject to stockholder approval, on May 14, 2025. The Plan Amendment became effective on June 30, 2025 following receipt of stockholder approval.

Additional information regarding the Plan Amendment is set forth in the Company’s Definitive Proxy Statement on Schedule 14A (the “Proxy Statement”) filed by the Company with the Securities and Exchange Commission on June 2, 2025, which information is incorporated herein by reference. Such information and the foregoing description of the Plan Amendment do not purport to be complete and are qualified in their entirety by reference to the full text of the Amendment No. 1 to Amended and Restated 2021 Equity Incentive Plan of the Company, a copy of which is attached to this Current Report Exhibit 10.2 and is incorporated herein by reference.

Item 5.07 Submission of Matters to a Vote of Security Holders.

On June 30, 2025, the Company held the Annual Meeting in a virtual format. As of the close of business on May 14, 2025, the record date for the Annual Meeting (the “Record Date”), there were 878,341 shares of Company common stock issued and outstanding. Holders of outstanding shares of the Company’s Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”) as of the Record Date were not entitled to vote such shares on any of the matters presented to stockholders for approval at the Annual Meeting. Accordingly, only stockholders of record of shares of the Company’s common stock as of the close of business on the Record Date were entitled to vote at the Annual Meeting. At the Annual Meeting, 360,210 of the Company’s 878,341 outstanding shares of common stock entitled to vote as of the Record Date, or approximately 41.0%, were represented by proxy or in person (virtually), and, therefore, a quorum was present.

As discussed in additional detail in the Proxy Statement, for purposes of the listing rules of the Nasdaq Stock Market, (i) holders of an aggregate of 111,339 shares of common stock as of the Record Date were not entitled to vote on Proposal No. 4, and (ii) the holder of 29,800 shares of common stock as of the Record Date was not entitled to vote on Proposal No. 6. Therefore, a total of 111,339 votes cast in favor of Proposal No. 4 and 29,800 votes cast in favor of Proposal No. 6 have been excluded from the voting results set forth below due to the fact that they were not entitled to be voted on such proposals in accordance with Nasdaq rules.

The proposals voted on at the Annual Meeting are more fully described in the Proxy Statement, which information is incorporated herein by reference.

The final voting results on the proposals presented for stockholder approval at the Annual Meeting were as follows:

Proposal No. 1: The Company’s stockholders elected one Class I director, to hold office until the Company’s 2028 annual meeting of stockholders, or until her successor is duly elected and qualified, subject to prior death, resignation or removal, as follows:

Name of Director

Votes For

Withhold

Broker Non-Votes

Christina Valauri

135,373

1,632

223,205

Proposal No. 2: The Company’s stockholders approved the Plan Amendment to increase the number of shares of the Company’s common stock authorized for issuance under the 2021 Plan by 425,000 shares, pursuant to the terms and conditions of the 2021 Plan, as follows:

Votes For

Votes Against

Abstentions

Broker Non-Votes

131,428

5,355

222

223,205

Proposal No. 3: The Company’s stockholders ratified the selection of Rosenberg Rich Baker Berman, P.A. as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2025, as follows:

Votes For

Votes Against

Abstentions

Broker Non-Votes

336,770

11,063

12,377

0

Proposal No. 4: The Company’s stockholders approved, in accordance with Nasdaq Listing Rule 5635(a) and Nasdaq Listing Rule 5635(d), the issuance of shares of the Company’s common stock, including upon conversion of shares of its Series A Preferred Stock that have been, or may in the future be, issued pursuant to that Exclusive License Agreement entered into by and between the Company and Statera Biopharma, Inc. on February 11, 2025, as may be amended from time to time, as follows:

Votes For

Votes Against

Abstentions

Broker Non-Votes

23,539*

1,801

326

223,205


* As noted above, excludes an aggregate of 111,339 votes cast in favor of Proposal No. 4, in accordance with Nasdaq listing rules.

Proposal No. 5: The Company’s stockholders approved, in accordance with Nasdaq Listing Rule 5635(d), the issuance of shares of the Company’s common stock upon conversion of those shares of its Series B Non-Voting Convertible Preferred Stock and exercise of those warrants to purchase shares of its common stock that the Company may in the future issue to an investor pursuant to that Securities Purchase Agreement entered into by and between the Company and such investor on April 29, 2025, as follows:

Votes For

Votes Against

Abstentions

Broker Non-Votes

134,864

1,815

326

223,205

Proposal No. 6: The Company’s stockholders approved, in accordance with Nasdaq Listing Rule 5635(d), the sale and issuance of shares of the Company’s common stock pursuant to that Equity Purchase Agreement entered into by and between the Company and Mast Hill Fund, L.P. on March 18, 2025, as follows:

Votes For

Votes Against

Abstentions

Broker Non-Votes

105,081*

1,814

310

223,205

* As noted above, excludes an aggregate of 29,800 votes cast in favor of Proposal No. 4, in accordance with Nasdaq listing rules.

Proposal No. 7: The Company’s stockholders approved the adjournment of the Annual Meeting to another place, or a later date or dates, if necessary or appropriate, to solicit additional proxies in the event the Company did not receive sufficient votes in favor of any of the foregoing proposals, as follows:

Votes For

Votes Against

Abstentions

Broker Non-Votes

355,002

4,563

645

0

Although Proposal No. 7 was approved by the Company’s stockholders, the Chair of the Annual Meeting did not elect to adjourn the meeting, as all of the foregoing proposals were also approved.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit No.

 

Description

10.1

 

Executive Employment Agreement, by and between Tivic Health Systems, Inc. and Lisa Wolf, effective July 7, 2025.

10.2

First Amendment to Tivic Health Systems, Inc. Amended and Restated 2021 Equity Incentive Plan, dated June 30, 2025.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


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 hereunto duly authorized.

 

 

 

TIVIC HEALTH SYSTEMS, INC.

 

 

 

 

Date:

July 7, 2025

By:

/s/ Jennifer Erst

 

 

 

Name: Jennifer Ernst
Title: Chief Executive Officer

 


Tivic Health Systems Inc

NASDAQ:TIVC

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4.01M
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5.29%
Medical Devices
Electromedical & Electrotherapeutic Apparatus
United States
FREMONT