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[S-3/A] Kaival Brands Innovations Group, Inc Amended Shelf Registration Statement

Filing Impact
(Low)
Filing Sentiment
(Neutral)
Form Type
S-3/A
Rhea-AI Filing Summary

BioVie Inc. (Nasdaq: BIVI) has filed Amendment No. 1 to its Form S-1 to complete a firm-commitment public offering that will roughly double the company’s share count and strengthen short-term liquidity.

  • Size & structure: 1,456,310 Units (one post-split Class A share + one 5-year warrant) or, for investors breaching the 4.99 %/9.99 % ownership caps, an equal number of Pre-funded Units (one pre-funded warrant + one warrant). Gross proceeds at the assumed $10.30 price equal ≈ $15.0 million; net ≈ $13.8 million after 7 % underwriting fees and estimated offering costs (exact expenses not yet disclosed). Underwriters hold a 45-day over-allotment option for 15 % additional securities.
  • Pricing metrics: Warrants strike at $12.875 (125 % of the assumed offer price) and will be listed on Nasdaq as “BIVIW” (listing application pending). Pre-funded warrants exercise at $0.0001 and will not be listed.
  • Capitalisation impact: Shares outstanding rise from 1,860,086 (6-30-25) to 3,316,396 before any warrant exercise—or 3,534,843 if the green-shoe is exercised in full—representing ≈ 78 % immediate dilution to existing holders. Potential dilution is greater when considering 960,098 legacy warrants (avg. $35.02 strike), 84,872 options (avg. $286.20 strike) and the new offering warrants (1.46 M) and banker warrants (≈ 0.15 M).
  • Reverse split executed: A 1-for-10 split became effective 7-7-25 to meet Nasdaq minimum bid requirements; all share figures reflect the split.
  • Use of proceeds: “Working capital and general corporate purposes” – presumed funding of ongoing clinical trials (bezisterim/NE3107 for Alzheimer’s, Parkinson’s and Long COVID; BIV201 terlipressin for ascites). No debt repayment or acquisition earmarked.
  • Pipeline status: – Phase 3 AD study unblinded but undermined by cGCP violations at 15 sites, leaving an under-powered data set (81 mITT / 57 per-protocol patients). Company evaluating additional enrolment or a new Phase 3. – Phase 2b Parkinson’s study green-lit by FDA and began April 2025. – DOD-funded Phase 2 Long COVID trial (ADDRESS-LC) commenced May 2025; $13.1 M grant with $2.9 M reimbursed YTD. – BIV201 Phase 3 protocol being finalised after recent FDA guidance. Orphan Drug & Fast-Track designations remain in force.
  • Litigation disclosure: Consolidated securities-fraud class action (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) survived a motion to dismiss on 3-27-25 and is now in discovery; insurer deductible is $2 M.
  • Risk highlights: continuing losses, need for repeated capital raises, substantial clinical and regulatory uncertainty, concentration of cash in one bank above FDIC limits, potential Nasdaq compliance issues if this offering is not deemed “public,” and broad indemnification/blank-check preferred provisions.

The filing positions BioVie to secure modest near-term funds but materially dilutes shareholders and does not address the more costly, pivotal trials still required for commercialization. Strategic success now hinges on swift resolution of AD data integrity questions, execution of new PD/Long-COVID trials, and eventual Phase 3 initiation for BIV201.

BioVie Inc. (Nasdaq: BIVI) ha presentato l'Emendamento n. 1 al suo Modulo S-1 per completare un'offerta pubblica a sottoscrizione garantita che raddoppierà approssimativamente il numero di azioni della società e rafforzerà la liquidità a breve termine.

  • Dimensioni e struttura: 1.456.310 Unità (una azione Classe A post-split + un warrant quinquennale) oppure, per gli investitori che superano i limiti di possesso del 4,99%/9,99%, un numero equivalente di Unità Pre-finanziate (un warrant pre-finanziato + un warrant). I proventi lordi al prezzo presunto di 10,30 $ ammontano a circa 15,0 milioni di dollari; netti circa 13,8 milioni dopo il 7% di commissioni di collocamento e i costi stimati dell'offerta (spese esatte non ancora comunicate). Gli underwriter detengono un'opzione di sovrallocazione del 15% per ulteriori titoli per 45 giorni.
  • Metriche di prezzo: I warrant hanno un prezzo di esercizio di 12,875 $ (125% del prezzo presunto dell'offerta) e saranno quotati al Nasdaq come "BIVIW" (domanda di quotazione in attesa). I warrant pre-finanziati si esercitano a 0,0001 $ e non saranno quotati.
  • Impatto sulla capitalizzazione: Le azioni in circolazione aumentano da 1.860.086 (30-06-25) a 3.316.396 prima di qualsiasi esercizio di warrant — o 3.534.843 se viene esercitata completamente l'opzione green-shoe — rappresentando una diluizione immediata di circa il 78% per gli azionisti esistenti. La diluizione potenziale è maggiore considerando 960.098 warrant legacy (prezzo medio di esercizio 35,02 $), 84.872 opzioni (prezzo medio 286,20 $), i warrant della nuova offerta (1,46 M) e quelli dei banchieri (circa 0,15 M).
  • Split inverso eseguito: Un frazionamento 1-per-10 è diventato effettivo il 7-7-25 per soddisfare i requisiti minimi di offerta del Nasdaq; tutti i dati azionari riflettono il frazionamento.
  • Utilizzo dei proventi: "Capitale circolante e scopi aziendali generali" – presumibilmente per finanziare gli studi clinici in corso (bezisterim/NE3107 per Alzheimer, Parkinson e Long COVID; BIV201 terlipressina per ascite). Nessun rimborso di debito o acquisizione prevista.
  • Stato della pipeline: – Studio di Fase 3 sull’AD svelato ma compromesso da violazioni cGCP in 15 siti, con un set di dati sottodimensionato (81 mITT / 57 pazienti per protocollo). La società valuta un eventuale arruolamento aggiuntivo o un nuovo studio di Fase 3. – Studio di Fase 2b per Parkinson approvato dalla FDA e iniziato ad aprile 2025. – Studio di Fase 2 sul Long COVID finanziato dal DOD (ADDRESS-LC) iniziato a maggio 2025; sovvenzione di 13,1 milioni di dollari con 2,9 milioni rimborsati finora. – Protocollo di Fase 3 per BIV201 in fase di finalizzazione dopo le recenti indicazioni FDA. Le designazioni Orphan Drug e Fast-Track rimangono valide.
  • Divulgazione legale: La causa collettiva consolidata per frode sui titoli (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) ha superato una mozione di rigetto il 27-3-25 ed è ora in fase di scoperta; la franchigia assicurativa è di 2 milioni di dollari.
  • Rischi principali: perdite continue, necessità di raccolte di capitale ripetute, sostanziale incertezza clinica e regolatoria, concentrazione di liquidità in una sola banca oltre i limiti FDIC, potenziali problemi di conformità Nasdaq se l’offerta non sarà considerata “pubblica” e ampie clausole di indennizzo/preferenze azionarie a discrezione.

La presentazione posiziona BioVie per assicurarsi fondi modesti a breve termine ma diluisce significativamente gli azionisti e non affronta gli studi più costosi e cruciali ancora necessari per la commercializzazione. Il successo strategico dipende ora dalla rapida risoluzione delle questioni di integrità dei dati sull’AD, dall’esecuzione dei nuovi studi su PD/Long COVID e dall’avvio finale della Fase 3 per BIV201.

BioVie Inc. (Nasdaq: BIVI) ha presentado la Enmienda N.º 1 a su Formulario S-1 para completar una oferta pública con compromiso firme que aproximadamente duplicará el número de acciones de la compañía y fortalecerá la liquidez a corto plazo.

  • Tamaño y estructura: 1.456.310 Unidades (una acción Clase A posterior a la división + un warrant a 5 años) o, para inversores que superen los límites de propiedad del 4,99 %/9,99 %, un número igual de Unidades Pre-financiadas (un warrant prefinanciado + un warrant). Los ingresos brutos al precio suponiendo 10,30 $ equivalen a ≈ 15,0 millones; netos ≈ 13,8 millones tras un 7 % de comisiones de suscripción y costos estimados de la oferta (gastos exactos aún no revelados). Los suscriptores tienen una opción de sobreasignación del 15 % para valores adicionales durante 45 días.
  • Métricas de precio: Los warrants tienen un precio de ejercicio de 12,875 $ (125 % del precio supuesto de la oferta) y se listarán en Nasdaq como "BIVIW" (solicitud de listado pendiente). Los warrants prefinanciados se ejercen a 0,0001 $ y no se listarán.
  • Impacto en la capitalización: Las acciones en circulación aumentan de 1.860.086 (30-06-25) a 3.316.396 antes de cualquier ejercicio de warrants — o a 3.534.843 si se ejerce completamente la opción green-shoe — representando ≈ 78 % de dilución inmediata para los accionistas actuales. La dilución potencial es mayor considerando 960.098 warrants heredados (precio medio de ejercicio 35,02 $), 84.872 opciones (precio medio 286,20 $), los warrants de la nueva oferta (1,46 M) y los warrants de los banqueros (≈ 0,15 M).
  • Split inverso ejecutado: Se hizo efectivo un split 1 por 10 el 7-7-25 para cumplir con los requisitos mínimos de cotización de Nasdaq; todas las cifras de acciones reflejan el split.
  • Uso de los ingresos: "Capital de trabajo y propósitos corporativos generales" – se presume que financiará los ensayos clínicos en curso (bezisterim/NE3107 para Alzheimer, Parkinson y Long COVID; BIV201 terlipresina para ascitis). No se destina para pago de deuda ni adquisiciones.
  • Estado de la cartera de productos: – Estudio de Fase 3 para AD desenmascarado pero afectado por violaciones cGCP en 15 sitios, dejando un conjunto de datos con poca potencia (81 mITT / 57 pacientes por protocolo). La compañía evalúa inscripciones adicionales o un nuevo estudio de Fase 3. – Estudio de Fase 2b para Parkinson aprobado por la FDA y comenzado en abril de 2025. – Ensayo de Fase 2 para Long COVID financiado por DOD (ADDRESS-LC) iniciado en mayo de 2025; subvención de 13,1 millones con 2,9 millones reembolsados hasta la fecha. – Protocolo de Fase 3 para BIV201 en finalización tras recientes orientaciones de la FDA. Las designaciones Orphan Drug y Fast-Track permanecen vigentes.
  • Divulgación legal: La demanda colectiva consolidada por fraude de valores (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) superó una moción para desestimar el 27-3-25 y está en fase de descubrimiento; deducible del seguro es de 2 millones.
  • Aspectos de riesgo: pérdidas continuas, necesidad de levantamientos de capital repetidos, incertidumbre clínica y regulatoria sustancial, concentración de efectivo en un solo banco por encima de los límites FDIC, posibles problemas de cumplimiento con Nasdaq si esta oferta no se considera "pública", e indemnizaciones amplias y provisiones preferentes tipo cheque en blanco.

La presentación posiciona a BioVie para asegurar fondos modestos a corto plazo pero diluye materialmente a los accionistas y no aborda los ensayos más costosos y cruciales aún necesarios para la comercialización. El éxito estratégico ahora depende de la rápida resolución de las dudas sobre la integridad de los datos de AD, la ejecución de nuevos ensayos para PD/Long COVID y el inicio eventual de la Fase 3 para BIV201.

BioVie Inc. (나스닥: BIVI)는 회사의 주식 수를 대략 두 배로 늘리고 단기 유동성을 강화하기 위한 확정 인수 공모를 완료하기 위해 Form S-1의 수정안 1호를 제출했습니다.

  • 규모 및 구조: 1,456,310 단위 (1주 포스트 스플릿 클래스 A 주식 + 5년 만기 워런트 1개) 또는 4.99%/9.99% 소유 한도를 초과하는 투자자에게는 동일 수량의 선납 워런트 단위(선납 워런트 1개 + 워런트 1개). 가정 가격 $10.30 기준 총 수익은 약 1,500만 달러, 7% 인수 수수료 및 예상 발행 비용(정확한 비용 미공개) 차감 후 순수익은 약 1,380만 달러입니다. 인수인은 45일간 추가 15% 증권에 대한 초과배정권을 보유합니다.
  • 가격 지표: 워런트 행사가격은 $12.875 (가정 공모가의 125%)이며, 나스닥에 “BIVIW”로 상장 예정(상장 신청 중). 선납 워런트 행사가격은 $0.0001이며 상장되지 않습니다.
  • 자본 구조 영향: 발행 주식 수는 2025년 6월 30일 기준 1,860,086주에서 워런트 행사 전 3,316,396주로 증가하며, 그린슈 옵션이 전량 행사되면 3,534,843주가 됩니다. 이는 기존 주주에게 약 78%의 즉각적인 희석을 의미합니다. 잠재적 희석은 960,098개의 기존 워런트(평균 행사가 $35.02), 84,872개의 옵션(평균 행사가 $286.20), 신규 공모 워런트(146만 개) 및 인수인 워런트(약 15만 개)를 포함할 경우 더 큽니다.
  • 역분할 시행: 2025년 7월 7일 나스닥 최저가 요건 충족을 위해 1대 10 역분할이 시행되었으며, 모든 주식 수치는 이를 반영합니다.
  • 자금 사용 목적: "운전자본 및 일반 기업 목적" – 진행 중인 임상시험(알츠하이머, 파킨슨, 롱코비드용 bezisterim/NE3107; 복수 치료용 BIV201 테를리프레신) 자금 조달로 추정됩니다. 부채 상환이나 인수 목적은 없습니다.
  • 파이프라인 현황: – 3상 AD 연구는 공개되었으나 15개 사이트에서 cGCP 위반으로 데이터 세트가 부족(81명 mITT / 57명 per-protocol). 추가 등록 또는 새로운 3상 시험을 검토 중입니다. – FDA 승인받은 2b상 파킨슨 연구는 2025년 4월 시작. – 국방부(DOD) 지원 2상 롱코비드 시험(ADDRESS-LC)은 2025년 5월 개시; 1,310만 달러 보조금 중 290만 달러가 올해 상환됨. – 최근 FDA 지침 후 BIV201 3상 프로토콜 최종 조율 중. 희귀의약품 및 패스트트랙 지정 유지.
  • 소송 공시: 통합된 증권 사기 집단 소송(In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035)은 2025년 3월 27일 기각 신청을 통과했고 현재 증거 개시 단계에 있으며, 보험 공제액은 200만 달러입니다.
  • 위험 요약: 지속적인 손실, 반복적인 자본 조달 필요성, 상당한 임상 및 규제 불확실성, FDIC 한도를 초과하는 단일 은행에 현금 집중, 본 공모가 "공개"로 간주되지 않을 경우 나스닥 규정 준수 문제 가능성, 광범위한 면책 및 백지 수표 우선주 조항 등.

이번 제출은 BioVie가 단기적으로 소규모 자금을 확보할 수 있도록 하지만 주주 희석이 크고 상업화를 위해 여전히 필요한 더 비용이 많이 드는 중대한 임상시험 문제는 해결하지 못합니다. 전략적 성공은 AD 데이터 무결성 문제의 신속한 해결, 신규 PD/롱코비드 시험의 실행, BIV201 3상 개시에 달려 있습니다.

BioVie Inc. (Nasdaq : BIVI) a déposé l’Amendement n°1 à son formulaire S-1 afin de finaliser une offre publique ferme qui va environ doubler le nombre d’actions de la société et renforcer la liquidité à court terme.

  • Taille et structure : 1 456 310 unités (une action de Classe A post-split + un warrant de 5 ans) ou, pour les investisseurs dépassant les plafonds de détention de 4,99 %/9,99 %, un nombre égal d’unités préfinancées (un warrant préfinancé + un warrant). Les produits bruts au prix supposé de 10,30 $ s’élèvent à environ 15,0 millions ; nets environ 13,8 millions après 7 % de frais de souscription et coûts estimés de l’offre (dépenses exactes non encore divulguées). Les souscripteurs détiennent une option de surallocation de 15 % supplémentaire pendant 45 jours.
  • Paramètres de tarification : Les warrants ont un prix d’exercice de 12,875 $ (125 % du prix supposé de l’offre) et seront cotés au Nasdaq sous le symbole « BIVIW » (demande de cotation en cours). Les warrants préfinancés s’exercent à 0,0001 $ et ne seront pas cotés.
  • Impact sur la capitalisation : Le nombre d’actions en circulation passe de 1 860 086 (30-06-25) à 3 316 396 avant tout exercice de warrant — ou 3 534 843 si l’option green-shoe est entièrement exercée — représentant une dilution immédiate d’environ 78 % pour les détenteurs actuels. La dilution potentielle est plus importante en tenant compte de 960 098 warrants anciens (prix d’exercice moyen 35,02 $), 84 872 options (prix moyen 286,20 $), des nouveaux warrants de l’offre (1,46 M) et des warrants des banquiers (≈ 0,15 M).
  • Fractionnement inversé effectué : Un fractionnement 1 pour 10 est entré en vigueur le 07-07-25 pour répondre aux exigences minimales de cotation Nasdaq ; tous les chiffres d’actions reflètent ce fractionnement.
  • Utilisation des fonds : « Fonds de roulement et objectifs généraux de l’entreprise » – présumé financer les essais cliniques en cours (bezisterim/NE3107 pour Alzheimer, Parkinson et Long COVID ; BIV201 terlipressine pour ascite). Aucun remboursement de dette ni acquisition prévu.
  • Statut du pipeline : – Étude de phase 3 sur la maladie d’Alzheimer dévoilée mais compromise par des violations des bonnes pratiques cliniques (cGCP) sur 15 sites, laissant un jeu de données sous-puissant (81 mITT / 57 patients per-protocole). La société évalue un recrutement supplémentaire ou une nouvelle phase 3. – Étude de phase 2b Parkinson approuvée par la FDA et commencée en avril 2025. – Essai de phase 2 Long COVID financé par le DOD (ADDRESS-LC) débuté en mai 2025 ; subvention de 13,1 M$ avec 2,9 M$ remboursés à ce jour. – Protocole de phase 3 pour BIV201 en finalisation après les récentes directives de la FDA. Les désignations Orphan Drug et Fast-Track restent en vigueur.
  • Divulgation judiciaire : Action collective consolidée pour fraude sur titres (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) a survécu à une requête en rejet le 27-03-25 et est désormais en phase de découverte ; franchise d’assurance de 2 M$.
  • Principaux risques : pertes continues, besoin de levées de fonds répétées, incertitudes cliniques et réglementaires importantes, concentration de trésorerie dans une seule banque au-delà des limites FDIC, problèmes potentiels de conformité Nasdaq si cette offre n’est pas considérée comme « publique », et larges dispositions d’indemnisation/actions privilégiées à chèque en blanc.

Le dépôt permet à BioVie d’obtenir des fonds modestes à court terme mais dilue considérablement les actionnaires et ne traite pas des essais plus coûteux et cruciaux encore nécessaires à la commercialisation. Le succès stratégique dépend désormais de la résolution rapide des questions d’intégrité des données sur la maladie d’Alzheimer, de l’exécution des nouveaux essais PD/Long COVID et du lancement final de la phase 3 pour BIV201.

BioVie Inc. (Nasdaq: BIVI) hat Änderungsantrag Nr. 1 zu seinem Formular S-1 eingereicht, um ein festverpflichtetes öffentliches Angebot abzuschließen, das die Anzahl der Aktien des Unternehmens etwa verdoppeln und die kurzfristige Liquidität stärken wird.

  • Größe & Struktur: 1.456.310 Einheiten (je eine nach Aktiensplit ausgegebene Klasse-A-Aktie + ein 5-Jahres-Warrant) oder für Investoren, die die Besitzgrenzen von 4,99 %/9,99 % überschreiten, eine gleiche Anzahl von vorfinanzierten Einheiten (ein vorfinanzierter Warrant + ein Warrant). Bruttoerlöse beim angenommenen Preis von 10,30 $ betragen ca. 15,0 Mio. $; netto ca. 13,8 Mio. $ nach 7 % Underwriting-Gebühren und geschätzten Angebotskosten (exakte Ausgaben noch nicht bekannt). Underwriter halten eine 45-tägige Mehrzuteilungsoption für zusätzliche 15 % der Wertpapiere.
  • Preiskennzahlen: Die Warrants haben einen Ausübungspreis von 12,875 $ (125 % des angenommenen Angebotspreises) und werden unter dem Symbol „BIVIW“ an der Nasdaq gelistet (Notierungsantrag läuft). Vorfinanzierte Warrants werden zu 0,0001 $ ausgeübt und nicht gelistet.
  • Kapitalisierungsauswirkung: Die ausstehenden Aktien steigen von 1.860.086 (30.06.25) auf 3.316.396 vor Ausübung von Warrants – oder auf 3.534.843 bei vollständiger Ausübung der Greenshoe-Option – was eine sofortige Verwässerung von ca. 78 % für bestehende Aktionäre bedeutet. Die potenzielle Verwässerung ist höher, wenn man 960.098 Alt-Warrants (durchschnittlicher Ausübungspreis 35,02 $), 84.872 Optionen (durchschnittlicher Ausübungspreis 286,20 $), die neuen Angebots-Warrants (1,46 Mio.) und Banker-Warrants (ca. 0,15 Mio.) berücksichtigt.
  • Reverse Split durchgeführt: Ein 1-zu-10-Split wurde am 07.07.25 wirksam, um die Mindestkursanforderungen der Nasdaq zu erfüllen; alle Aktienzahlen spiegeln den Split wider.
  • Verwendung der Erlöse: „Betriebskapital und allgemeine Unternehmenszwecke“ – vermutlich zur Finanzierung laufender klinischer Studien (bezisterim/NE3107 für Alzheimer, Parkinson und Long COVID; BIV201 Terlipressin für Aszites). Keine Tilgung von Schulden oder Akquisitionen vorgesehen.
  • Status der Pipeline: – Phase-3-AD-Studie wurde entblindet, ist jedoch durch cGCP-Verstöße an 15 Standorten beeinträchtigt, was zu einem unterdimensionierten Datensatz führt (81 mITT / 57 per Protokoll). Das Unternehmen prüft eine zusätzliche Rekrutierung oder eine neue Phase-3-Studie. – Phase-2b-Parkinson-Studie von der FDA genehmigt und im April 2025 gestartet. – DOD-finanzierte Phase-2-Long-COVID-Studie (ADDRESS-LC) begann im Mai 2025; 13,1 Mio. $ Zuschuss, davon 2,9 Mio. $ bisher erstattet. – Phase-3-Protokoll für BIV201 wird nach jüngster FDA-Anleitung finalisiert. Orphan-Drug- und Fast-Track-Designationen bleiben bestehen.
  • Rechtsstreitigkeiten: Konsolidierte Sammelklage wegen Wertpapierbetrugs (In re BioVie Inc. Securities Litigation, D.Nev. Nr. 3:24-cv-00035) überstand am 27.03.25 einen Abweisungsantrag und befindet sich nun in der Beweisaufnahme; Selbstbehalt der Versicherung beträgt 2 Mio. $.
  • Risikohighlights: anhaltende Verluste, Bedarf an wiederholten Kapitalerhöhungen, erhebliche klinische und regulatorische Unsicherheit, Konzentration von Bargeld bei einer Bank über FDIC-Grenzen hinaus, potenzielle Nasdaq-Compliance-Probleme, falls dieses Angebot nicht als „öffentlich“ gilt, sowie umfangreiche Entschädigungs- und Blankoscheck-Vorzugsbestimmungen.

Die Einreichung versetzt BioVie in die Lage, kurzfristig bescheidene Mittel zu sichern, verwässert jedoch die Aktionäre erheblich und adressiert nicht die teureren, entscheidenden Studien, die für die Kommerzialisierung noch erforderlich sind. Der strategische Erfolg hängt nun von der schnellen Klärung der AD-Datenintegritätsfragen, der Durchführung der neuen PD-/Long-COVID-Studien und dem letztendlichen Start der Phase 3 für BIV201 ab.

Positive
  • Reverse stock split successfully restored Nasdaq bid-price compliance, avoiding imminent delisting.
  • $15 million gross capital infusion (≈ $14 M net) extends cash runway and funds ongoing trials.
  • DoD grant of $13.1 million fully finances the Phase 2 Long-COVID study, reducing out-of-pocket R&D spend.
  • Fast-Track & Orphan Drug designations for BIV201 could accelerate review and provide marketing exclusivity if approved.
Negative
  • Immediate dilution of ~78 % to existing shareholders, with additional over-allotment and warrant overhang.
  • Phase 3 Alzheimer’s trial data integrity issues leave the lead indication underpowered and delay regulatory pathway.
  • Securities-fraud class action survived dismissal; potential liabilities and $2 M deductible may strain cash.
  • Offering proceeds are insufficient to fund pivotal trials, implying further dilution-inducing raises will be needed.
  • Reverse split risk: reduced float may heighten volatility and potential price erosion post-offering.

Insights

TL;DR – Capital raise improves runway but comes with 78 % dilution; pipeline catalysts remain high-risk.

The S-1/A reveals an offer sized to bring in roughly $14 M net, extending cash life by an estimated 2-3 quarters based on FY-24 burn rates. The simultaneous 1-for-10 reverse split restored Nasdaq bid-price compliance but shrank the public float, making dilution mathematically severe. Warrants priced at a 25 % premium may cap near-term upside while adding 1.46 M potential shares. Importantly, management has not yet resolved the data-integrity overhang in its Phase 3 Alzheimer’s program; without an expanded or new trial, FDA approval is implausible. Positive signals include a fully funded $13.1 M DoD Long-COVID study and ongoing PD Phase 2b. Nonetheless, with no commercial product and ongoing securities litigation, risk remains elevated. I view the amendment as neutral overall (rating 0): necessary financing achieved, but no change to fundamental outlook.

TL;DR – Offering meets compliance goals but amplifies overhangs: warrants, litigation, Nasdaq risk.

Post-split share price near $8.50 implies the bookrunner must discount meaningfully to clear the book, raising the possibility the unit price prices below assumed $10.30. If so, exercise prices and warrant strikes reset lower, increasing dilution. The underwriter’s over-allotment and 5 % representative warrants further pressure cap-table optics. While proceeds cover day-to-day ops, they are insufficient for a full Phase 3 (~$50-70 M), guaranteeing additional raises. The securities class action, now in discovery, may sap management bandwidth and cash (first $2 M uninsured). Should the deal fail Nasdaq’s “public offering” test, BIVI must seek alternative shareholder-approval solutions. Net impact: financing is incrementally helpful but does not materially de-risk the longer-term funding gap; I assign a neutral rating 0.

BioVie Inc. (Nasdaq: BIVI) ha presentato l'Emendamento n. 1 al suo Modulo S-1 per completare un'offerta pubblica a sottoscrizione garantita che raddoppierà approssimativamente il numero di azioni della società e rafforzerà la liquidità a breve termine.

  • Dimensioni e struttura: 1.456.310 Unità (una azione Classe A post-split + un warrant quinquennale) oppure, per gli investitori che superano i limiti di possesso del 4,99%/9,99%, un numero equivalente di Unità Pre-finanziate (un warrant pre-finanziato + un warrant). I proventi lordi al prezzo presunto di 10,30 $ ammontano a circa 15,0 milioni di dollari; netti circa 13,8 milioni dopo il 7% di commissioni di collocamento e i costi stimati dell'offerta (spese esatte non ancora comunicate). Gli underwriter detengono un'opzione di sovrallocazione del 15% per ulteriori titoli per 45 giorni.
  • Metriche di prezzo: I warrant hanno un prezzo di esercizio di 12,875 $ (125% del prezzo presunto dell'offerta) e saranno quotati al Nasdaq come "BIVIW" (domanda di quotazione in attesa). I warrant pre-finanziati si esercitano a 0,0001 $ e non saranno quotati.
  • Impatto sulla capitalizzazione: Le azioni in circolazione aumentano da 1.860.086 (30-06-25) a 3.316.396 prima di qualsiasi esercizio di warrant — o 3.534.843 se viene esercitata completamente l'opzione green-shoe — rappresentando una diluizione immediata di circa il 78% per gli azionisti esistenti. La diluizione potenziale è maggiore considerando 960.098 warrant legacy (prezzo medio di esercizio 35,02 $), 84.872 opzioni (prezzo medio 286,20 $), i warrant della nuova offerta (1,46 M) e quelli dei banchieri (circa 0,15 M).
  • Split inverso eseguito: Un frazionamento 1-per-10 è diventato effettivo il 7-7-25 per soddisfare i requisiti minimi di offerta del Nasdaq; tutti i dati azionari riflettono il frazionamento.
  • Utilizzo dei proventi: "Capitale circolante e scopi aziendali generali" – presumibilmente per finanziare gli studi clinici in corso (bezisterim/NE3107 per Alzheimer, Parkinson e Long COVID; BIV201 terlipressina per ascite). Nessun rimborso di debito o acquisizione prevista.
  • Stato della pipeline: – Studio di Fase 3 sull’AD svelato ma compromesso da violazioni cGCP in 15 siti, con un set di dati sottodimensionato (81 mITT / 57 pazienti per protocollo). La società valuta un eventuale arruolamento aggiuntivo o un nuovo studio di Fase 3. – Studio di Fase 2b per Parkinson approvato dalla FDA e iniziato ad aprile 2025. – Studio di Fase 2 sul Long COVID finanziato dal DOD (ADDRESS-LC) iniziato a maggio 2025; sovvenzione di 13,1 milioni di dollari con 2,9 milioni rimborsati finora. – Protocollo di Fase 3 per BIV201 in fase di finalizzazione dopo le recenti indicazioni FDA. Le designazioni Orphan Drug e Fast-Track rimangono valide.
  • Divulgazione legale: La causa collettiva consolidata per frode sui titoli (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) ha superato una mozione di rigetto il 27-3-25 ed è ora in fase di scoperta; la franchigia assicurativa è di 2 milioni di dollari.
  • Rischi principali: perdite continue, necessità di raccolte di capitale ripetute, sostanziale incertezza clinica e regolatoria, concentrazione di liquidità in una sola banca oltre i limiti FDIC, potenziali problemi di conformità Nasdaq se l’offerta non sarà considerata “pubblica” e ampie clausole di indennizzo/preferenze azionarie a discrezione.

La presentazione posiziona BioVie per assicurarsi fondi modesti a breve termine ma diluisce significativamente gli azionisti e non affronta gli studi più costosi e cruciali ancora necessari per la commercializzazione. Il successo strategico dipende ora dalla rapida risoluzione delle questioni di integrità dei dati sull’AD, dall’esecuzione dei nuovi studi su PD/Long COVID e dall’avvio finale della Fase 3 per BIV201.

BioVie Inc. (Nasdaq: BIVI) ha presentado la Enmienda N.º 1 a su Formulario S-1 para completar una oferta pública con compromiso firme que aproximadamente duplicará el número de acciones de la compañía y fortalecerá la liquidez a corto plazo.

  • Tamaño y estructura: 1.456.310 Unidades (una acción Clase A posterior a la división + un warrant a 5 años) o, para inversores que superen los límites de propiedad del 4,99 %/9,99 %, un número igual de Unidades Pre-financiadas (un warrant prefinanciado + un warrant). Los ingresos brutos al precio suponiendo 10,30 $ equivalen a ≈ 15,0 millones; netos ≈ 13,8 millones tras un 7 % de comisiones de suscripción y costos estimados de la oferta (gastos exactos aún no revelados). Los suscriptores tienen una opción de sobreasignación del 15 % para valores adicionales durante 45 días.
  • Métricas de precio: Los warrants tienen un precio de ejercicio de 12,875 $ (125 % del precio supuesto de la oferta) y se listarán en Nasdaq como "BIVIW" (solicitud de listado pendiente). Los warrants prefinanciados se ejercen a 0,0001 $ y no se listarán.
  • Impacto en la capitalización: Las acciones en circulación aumentan de 1.860.086 (30-06-25) a 3.316.396 antes de cualquier ejercicio de warrants — o a 3.534.843 si se ejerce completamente la opción green-shoe — representando ≈ 78 % de dilución inmediata para los accionistas actuales. La dilución potencial es mayor considerando 960.098 warrants heredados (precio medio de ejercicio 35,02 $), 84.872 opciones (precio medio 286,20 $), los warrants de la nueva oferta (1,46 M) y los warrants de los banqueros (≈ 0,15 M).
  • Split inverso ejecutado: Se hizo efectivo un split 1 por 10 el 7-7-25 para cumplir con los requisitos mínimos de cotización de Nasdaq; todas las cifras de acciones reflejan el split.
  • Uso de los ingresos: "Capital de trabajo y propósitos corporativos generales" – se presume que financiará los ensayos clínicos en curso (bezisterim/NE3107 para Alzheimer, Parkinson y Long COVID; BIV201 terlipresina para ascitis). No se destina para pago de deuda ni adquisiciones.
  • Estado de la cartera de productos: – Estudio de Fase 3 para AD desenmascarado pero afectado por violaciones cGCP en 15 sitios, dejando un conjunto de datos con poca potencia (81 mITT / 57 pacientes por protocolo). La compañía evalúa inscripciones adicionales o un nuevo estudio de Fase 3. – Estudio de Fase 2b para Parkinson aprobado por la FDA y comenzado en abril de 2025. – Ensayo de Fase 2 para Long COVID financiado por DOD (ADDRESS-LC) iniciado en mayo de 2025; subvención de 13,1 millones con 2,9 millones reembolsados hasta la fecha. – Protocolo de Fase 3 para BIV201 en finalización tras recientes orientaciones de la FDA. Las designaciones Orphan Drug y Fast-Track permanecen vigentes.
  • Divulgación legal: La demanda colectiva consolidada por fraude de valores (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) superó una moción para desestimar el 27-3-25 y está en fase de descubrimiento; deducible del seguro es de 2 millones.
  • Aspectos de riesgo: pérdidas continuas, necesidad de levantamientos de capital repetidos, incertidumbre clínica y regulatoria sustancial, concentración de efectivo en un solo banco por encima de los límites FDIC, posibles problemas de cumplimiento con Nasdaq si esta oferta no se considera "pública", e indemnizaciones amplias y provisiones preferentes tipo cheque en blanco.

La presentación posiciona a BioVie para asegurar fondos modestos a corto plazo pero diluye materialmente a los accionistas y no aborda los ensayos más costosos y cruciales aún necesarios para la comercialización. El éxito estratégico ahora depende de la rápida resolución de las dudas sobre la integridad de los datos de AD, la ejecución de nuevos ensayos para PD/Long COVID y el inicio eventual de la Fase 3 para BIV201.

BioVie Inc. (나스닥: BIVI)는 회사의 주식 수를 대략 두 배로 늘리고 단기 유동성을 강화하기 위한 확정 인수 공모를 완료하기 위해 Form S-1의 수정안 1호를 제출했습니다.

  • 규모 및 구조: 1,456,310 단위 (1주 포스트 스플릿 클래스 A 주식 + 5년 만기 워런트 1개) 또는 4.99%/9.99% 소유 한도를 초과하는 투자자에게는 동일 수량의 선납 워런트 단위(선납 워런트 1개 + 워런트 1개). 가정 가격 $10.30 기준 총 수익은 약 1,500만 달러, 7% 인수 수수료 및 예상 발행 비용(정확한 비용 미공개) 차감 후 순수익은 약 1,380만 달러입니다. 인수인은 45일간 추가 15% 증권에 대한 초과배정권을 보유합니다.
  • 가격 지표: 워런트 행사가격은 $12.875 (가정 공모가의 125%)이며, 나스닥에 “BIVIW”로 상장 예정(상장 신청 중). 선납 워런트 행사가격은 $0.0001이며 상장되지 않습니다.
  • 자본 구조 영향: 발행 주식 수는 2025년 6월 30일 기준 1,860,086주에서 워런트 행사 전 3,316,396주로 증가하며, 그린슈 옵션이 전량 행사되면 3,534,843주가 됩니다. 이는 기존 주주에게 약 78%의 즉각적인 희석을 의미합니다. 잠재적 희석은 960,098개의 기존 워런트(평균 행사가 $35.02), 84,872개의 옵션(평균 행사가 $286.20), 신규 공모 워런트(146만 개) 및 인수인 워런트(약 15만 개)를 포함할 경우 더 큽니다.
  • 역분할 시행: 2025년 7월 7일 나스닥 최저가 요건 충족을 위해 1대 10 역분할이 시행되었으며, 모든 주식 수치는 이를 반영합니다.
  • 자금 사용 목적: "운전자본 및 일반 기업 목적" – 진행 중인 임상시험(알츠하이머, 파킨슨, 롱코비드용 bezisterim/NE3107; 복수 치료용 BIV201 테를리프레신) 자금 조달로 추정됩니다. 부채 상환이나 인수 목적은 없습니다.
  • 파이프라인 현황: – 3상 AD 연구는 공개되었으나 15개 사이트에서 cGCP 위반으로 데이터 세트가 부족(81명 mITT / 57명 per-protocol). 추가 등록 또는 새로운 3상 시험을 검토 중입니다. – FDA 승인받은 2b상 파킨슨 연구는 2025년 4월 시작. – 국방부(DOD) 지원 2상 롱코비드 시험(ADDRESS-LC)은 2025년 5월 개시; 1,310만 달러 보조금 중 290만 달러가 올해 상환됨. – 최근 FDA 지침 후 BIV201 3상 프로토콜 최종 조율 중. 희귀의약품 및 패스트트랙 지정 유지.
  • 소송 공시: 통합된 증권 사기 집단 소송(In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035)은 2025년 3월 27일 기각 신청을 통과했고 현재 증거 개시 단계에 있으며, 보험 공제액은 200만 달러입니다.
  • 위험 요약: 지속적인 손실, 반복적인 자본 조달 필요성, 상당한 임상 및 규제 불확실성, FDIC 한도를 초과하는 단일 은행에 현금 집중, 본 공모가 "공개"로 간주되지 않을 경우 나스닥 규정 준수 문제 가능성, 광범위한 면책 및 백지 수표 우선주 조항 등.

이번 제출은 BioVie가 단기적으로 소규모 자금을 확보할 수 있도록 하지만 주주 희석이 크고 상업화를 위해 여전히 필요한 더 비용이 많이 드는 중대한 임상시험 문제는 해결하지 못합니다. 전략적 성공은 AD 데이터 무결성 문제의 신속한 해결, 신규 PD/롱코비드 시험의 실행, BIV201 3상 개시에 달려 있습니다.

BioVie Inc. (Nasdaq : BIVI) a déposé l’Amendement n°1 à son formulaire S-1 afin de finaliser une offre publique ferme qui va environ doubler le nombre d’actions de la société et renforcer la liquidité à court terme.

  • Taille et structure : 1 456 310 unités (une action de Classe A post-split + un warrant de 5 ans) ou, pour les investisseurs dépassant les plafonds de détention de 4,99 %/9,99 %, un nombre égal d’unités préfinancées (un warrant préfinancé + un warrant). Les produits bruts au prix supposé de 10,30 $ s’élèvent à environ 15,0 millions ; nets environ 13,8 millions après 7 % de frais de souscription et coûts estimés de l’offre (dépenses exactes non encore divulguées). Les souscripteurs détiennent une option de surallocation de 15 % supplémentaire pendant 45 jours.
  • Paramètres de tarification : Les warrants ont un prix d’exercice de 12,875 $ (125 % du prix supposé de l’offre) et seront cotés au Nasdaq sous le symbole « BIVIW » (demande de cotation en cours). Les warrants préfinancés s’exercent à 0,0001 $ et ne seront pas cotés.
  • Impact sur la capitalisation : Le nombre d’actions en circulation passe de 1 860 086 (30-06-25) à 3 316 396 avant tout exercice de warrant — ou 3 534 843 si l’option green-shoe est entièrement exercée — représentant une dilution immédiate d’environ 78 % pour les détenteurs actuels. La dilution potentielle est plus importante en tenant compte de 960 098 warrants anciens (prix d’exercice moyen 35,02 $), 84 872 options (prix moyen 286,20 $), des nouveaux warrants de l’offre (1,46 M) et des warrants des banquiers (≈ 0,15 M).
  • Fractionnement inversé effectué : Un fractionnement 1 pour 10 est entré en vigueur le 07-07-25 pour répondre aux exigences minimales de cotation Nasdaq ; tous les chiffres d’actions reflètent ce fractionnement.
  • Utilisation des fonds : « Fonds de roulement et objectifs généraux de l’entreprise » – présumé financer les essais cliniques en cours (bezisterim/NE3107 pour Alzheimer, Parkinson et Long COVID ; BIV201 terlipressine pour ascite). Aucun remboursement de dette ni acquisition prévu.
  • Statut du pipeline : – Étude de phase 3 sur la maladie d’Alzheimer dévoilée mais compromise par des violations des bonnes pratiques cliniques (cGCP) sur 15 sites, laissant un jeu de données sous-puissant (81 mITT / 57 patients per-protocole). La société évalue un recrutement supplémentaire ou une nouvelle phase 3. – Étude de phase 2b Parkinson approuvée par la FDA et commencée en avril 2025. – Essai de phase 2 Long COVID financé par le DOD (ADDRESS-LC) débuté en mai 2025 ; subvention de 13,1 M$ avec 2,9 M$ remboursés à ce jour. – Protocole de phase 3 pour BIV201 en finalisation après les récentes directives de la FDA. Les désignations Orphan Drug et Fast-Track restent en vigueur.
  • Divulgation judiciaire : Action collective consolidée pour fraude sur titres (In re BioVie Inc. Securities Litigation, D.Nev. No. 3:24-cv-00035) a survécu à une requête en rejet le 27-03-25 et est désormais en phase de découverte ; franchise d’assurance de 2 M$.
  • Principaux risques : pertes continues, besoin de levées de fonds répétées, incertitudes cliniques et réglementaires importantes, concentration de trésorerie dans une seule banque au-delà des limites FDIC, problèmes potentiels de conformité Nasdaq si cette offre n’est pas considérée comme « publique », et larges dispositions d’indemnisation/actions privilégiées à chèque en blanc.

Le dépôt permet à BioVie d’obtenir des fonds modestes à court terme mais dilue considérablement les actionnaires et ne traite pas des essais plus coûteux et cruciaux encore nécessaires à la commercialisation. Le succès stratégique dépend désormais de la résolution rapide des questions d’intégrité des données sur la maladie d’Alzheimer, de l’exécution des nouveaux essais PD/Long COVID et du lancement final de la phase 3 pour BIV201.

BioVie Inc. (Nasdaq: BIVI) hat Änderungsantrag Nr. 1 zu seinem Formular S-1 eingereicht, um ein festverpflichtetes öffentliches Angebot abzuschließen, das die Anzahl der Aktien des Unternehmens etwa verdoppeln und die kurzfristige Liquidität stärken wird.

  • Größe & Struktur: 1.456.310 Einheiten (je eine nach Aktiensplit ausgegebene Klasse-A-Aktie + ein 5-Jahres-Warrant) oder für Investoren, die die Besitzgrenzen von 4,99 %/9,99 % überschreiten, eine gleiche Anzahl von vorfinanzierten Einheiten (ein vorfinanzierter Warrant + ein Warrant). Bruttoerlöse beim angenommenen Preis von 10,30 $ betragen ca. 15,0 Mio. $; netto ca. 13,8 Mio. $ nach 7 % Underwriting-Gebühren und geschätzten Angebotskosten (exakte Ausgaben noch nicht bekannt). Underwriter halten eine 45-tägige Mehrzuteilungsoption für zusätzliche 15 % der Wertpapiere.
  • Preiskennzahlen: Die Warrants haben einen Ausübungspreis von 12,875 $ (125 % des angenommenen Angebotspreises) und werden unter dem Symbol „BIVIW“ an der Nasdaq gelistet (Notierungsantrag läuft). Vorfinanzierte Warrants werden zu 0,0001 $ ausgeübt und nicht gelistet.
  • Kapitalisierungsauswirkung: Die ausstehenden Aktien steigen von 1.860.086 (30.06.25) auf 3.316.396 vor Ausübung von Warrants – oder auf 3.534.843 bei vollständiger Ausübung der Greenshoe-Option – was eine sofortige Verwässerung von ca. 78 % für bestehende Aktionäre bedeutet. Die potenzielle Verwässerung ist höher, wenn man 960.098 Alt-Warrants (durchschnittlicher Ausübungspreis 35,02 $), 84.872 Optionen (durchschnittlicher Ausübungspreis 286,20 $), die neuen Angebots-Warrants (1,46 Mio.) und Banker-Warrants (ca. 0,15 Mio.) berücksichtigt.
  • Reverse Split durchgeführt: Ein 1-zu-10-Split wurde am 07.07.25 wirksam, um die Mindestkursanforderungen der Nasdaq zu erfüllen; alle Aktienzahlen spiegeln den Split wider.
  • Verwendung der Erlöse: „Betriebskapital und allgemeine Unternehmenszwecke“ – vermutlich zur Finanzierung laufender klinischer Studien (bezisterim/NE3107 für Alzheimer, Parkinson und Long COVID; BIV201 Terlipressin für Aszites). Keine Tilgung von Schulden oder Akquisitionen vorgesehen.
  • Status der Pipeline: – Phase-3-AD-Studie wurde entblindet, ist jedoch durch cGCP-Verstöße an 15 Standorten beeinträchtigt, was zu einem unterdimensionierten Datensatz führt (81 mITT / 57 per Protokoll). Das Unternehmen prüft eine zusätzliche Rekrutierung oder eine neue Phase-3-Studie. – Phase-2b-Parkinson-Studie von der FDA genehmigt und im April 2025 gestartet. – DOD-finanzierte Phase-2-Long-COVID-Studie (ADDRESS-LC) begann im Mai 2025; 13,1 Mio. $ Zuschuss, davon 2,9 Mio. $ bisher erstattet. – Phase-3-Protokoll für BIV201 wird nach jüngster FDA-Anleitung finalisiert. Orphan-Drug- und Fast-Track-Designationen bleiben bestehen.
  • Rechtsstreitigkeiten: Konsolidierte Sammelklage wegen Wertpapierbetrugs (In re BioVie Inc. Securities Litigation, D.Nev. Nr. 3:24-cv-00035) überstand am 27.03.25 einen Abweisungsantrag und befindet sich nun in der Beweisaufnahme; Selbstbehalt der Versicherung beträgt 2 Mio. $.
  • Risikohighlights: anhaltende Verluste, Bedarf an wiederholten Kapitalerhöhungen, erhebliche klinische und regulatorische Unsicherheit, Konzentration von Bargeld bei einer Bank über FDIC-Grenzen hinaus, potenzielle Nasdaq-Compliance-Probleme, falls dieses Angebot nicht als „öffentlich“ gilt, sowie umfangreiche Entschädigungs- und Blankoscheck-Vorzugsbestimmungen.

Die Einreichung versetzt BioVie in die Lage, kurzfristig bescheidene Mittel zu sichern, verwässert jedoch die Aktionäre erheblich und adressiert nicht die teureren, entscheidenden Studien, die für die Kommerzialisierung noch erforderlich sind. Der strategische Erfolg hängt nun von der schnellen Klärung der AD-Datenintegritätsfragen, der Durchführung der neuen PD-/Long-COVID-Studien und dem letztendlichen Start der Phase 3 für BIV201 ab.

 

 

As filed with the Securities and Exchange Commission on July 11, 2025

 

Registration No. 333-288091

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

AMENDMENT NO. 1 TO

 

FORM S-3

 

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

KAIVAL BRANDS INNOVATIONS GROUP, INC.
(Exact name of registrant as specified in its charter)

 

Delaware   5960   83-3492907

(State or Other Jurisdiction of

Incorporation or Organization)

 

(Primary Standard Industrial

Classification Code Number)

(I.R.S. Employer

Identification No.)

 

460 Old Dixie Highway

Grant-Valkaria, Florida 32949

(833) 452-4825

(Address, including zip code, and telephone number, including area code,

of registrant’s principal executive offices)

 

Mark Thoenes

Chief Executive Officer

460 Old Dixie Highway

Grant-Valkaria, Florida 32949

(833) 452-4825

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

Copies to:

 

Ross D. Carmel, Esq.
Jeffrey P. Wofford, Esq.
Sichenzia Ross Ference Carmel LLP
1185 Avenue of the Americas, 31st Floor
New York, New York 10036
Telephone: (212) 930-9700

 

Approximate date of commencement of proposed sale to the public: From time to time after this registration statement becomes effective.

 

If the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.

 

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”), other than securities offered only in connection with dividend or interest reinvestment plans, check the following box.

 

 

 

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

 

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.

 

If this form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, please check the following box.

 

If this form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, please check the following box.

 

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 7(a)(2)(B) of the Securities Act.

 

 

 

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

EXPLANATION OF THE FILING

 

This shelf registration statement will provide our company with the flexibility to issue and sell securities if and when deemed appropriate and in the best interest of our stockholders. We may or may not issue and sell any securities under this registration statement. Filing this registration statement merely gives us flexibility to issue registered securities if and when we deem doing so is appropriate and in the best interest of our stockholders, without any unnecessary delays. This registration statement helps us maintain an optimal state of readiness at all times.

 

This pre-effective Amendment No. 1 to the Registration Statement on Form S-3 (File No. 333-288091) is being filed solely to file the form of trust indenture as Exhibit 4.6. Accordingly, this Amendment No. 1 consists solely of the facing page, this explanatory note, Part II of the Registration Statement, the signature page to the Registration Statement, the exhibit index and the filed Exhibit 4.6. The prospectus contained in Part I of the Registration Statement is unchanged and has been omitted from this filing.

 

 

 

PART II

 

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 14. Other Expenses of Issuance and Distribution

 

The following table sets forth the various expenses in connection with the registration of the securities offered hereby. We will bear all of these expenses. All amounts are estimated except for the SEC registration fee:

 

Item  Amount
SEC registration fee  $15,310 
FINRA filing fee  $15,500 
Legal fees and expenses  $100,000 
Accounting fees and expenses  $20,000 
Printing and related expenses  $5,000 
Miscellaneous  $10,000 
Total  $165,810 

  

Item 15. Indemnification of Directors and Officers

 

Section 102 of the General Company Law of the State of Delaware (“DGCL”) permits a Company to eliminate the personal liability of directors of a Company to the Company or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. Our charter, as amended provides that no director of the Company shall be personally liable to it or its stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability, except to the extent that the DGCL prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty.

 

Section 145 of the DGCL provides that a Company has the power to indemnify a director, officer, employee, or agent of the Company, or a person serving at the request of the Company for another Company, partnership, joint venture, trust or other enterprise in related capacities against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with an action, suit or proceeding to which he was or is a party or is threatened to be made a party to any threatened, ending or completed action, suit or proceeding by reason of such position, if such person acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company, and, in any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful, except that, in the case of actions brought by or in the right of the Company, no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liable to the Company unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.

 

Our charter and bylaws provide for the indemnification, to the fullest extent permitted from time to time by the DGCL or any other applicable laws as presently or hereafter in effect, any person who was or is made a party or is threatened to be made a party or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or she, or a person for whom he or she is the legal representative, is or was a director or officer of the Company or, while a director or officer of the Company, is or was serving at the request of the Company as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust, enterprise or nonprofit entity, including service with respect to employee benefit plans, against all liability and loss suffered and reasonably incurred by such person.

 

Our bylaws provide that if an indemnification claim made by an officer or director of the Company is not paid in full by the Company within thirty (30) days after a written claim has been received by the Company, the claimant may at any time thereafter bring suit against the Company to recover the unpaid amount of the claim and, if successful in whole or in part, the claimant shall also be entitled to be paid the expense of prosecuting such claim. It shall be a defense to any such action (other than an action brought to enforce a claim for expenses incurred in defending any proceeding in advance of its final disposition where any required undertaking has been tendered to the Company) that the claimant has not met the standards of conduct which make it permissible under the DGCL for the Company to indemnify the claimant for the amount claimed, but the burden of proving such defense shall be on the Company. Neither the failure of the Company (including its board of directors (“Board”), legal counsel, or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he or she has met the applicable standard of conduct set forth in the DGCL, nor an actual determination by the Company (including its Board, legal counsel, or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that the claimant has not met the applicable standard of conduct.

 

II-1

 

 

The right of our directors and officers to indemnification under our charter and bylaws is not exclusive of any other right which they may have or hereafter acquire under any statute, our charter, our bylaws, any agreement, vote of stockholders or disinterested directors or otherwise.

 

The Company may also maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Company or another corporation, partnership, joint venture, trust or other enterprise against any such expense, liability or loss, whether or not the Company would have the power to indemnify such person against such expense, liability or loss under the DGCL or under the provisions of our bylaws.

 

In any underwriting agreement we enter into in connection with the sale of common stock being registered hereby, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act of 1933, as amended, or the Securities Act, against certain liabilities.

 

These indemnification provisions may be sufficiently broad to permit indemnification of our directors and officers for liabilities (including reimbursement of expenses incurred) arising under the Securities Act.

 

Item 16. Exhibits

 

The following Exhibits are filed herewith or incorporated herein by reference:

 

II-2

 

 

EXHIBIT INDEX

 

No.   Exhibit No.
1.1**   Form of Underwriting Agreement or Purchase Agreement
3.1   Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Kaival Brands Innovations Group, Inc.’s Registration Statement on Form 10-12G filed with the Securities and Exchange Commission on March 25, 2019).
3.2   Bylaws, which were filed as Exhibit 3.2 to our Registration Statement on Form 10-12G filed with the Securities and Exchange Commission on February 19, 2019, and are incorporated herein by reference thereto.
3.3   Certificate of Ownership and Merger, as filed with the Secretary of State of the State of Delaware on June 20, 2019, which was filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 15, 2019, and is incorporated herein by reference thereto.
3.4   Certificate of Correction, as filed with the Secretary of State of the State of Delaware on July 15, 2019, which was filed as Exhibit 3.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 15, 2019, and is incorporated herein by reference thereto.
3.5   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Kaival Brands Innovations Group, Inc., effective July 20, 2021, which was filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 20, 2021, and is incorporated herein by reference thereto.
3.6   Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Preferred Stock, dated May 30, 2023, which was filed as Exhibit 3.1 to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on June 14, 2023, and is incorporated herein by reference thereto.
3.7   Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Kaival Brands Innovations Group, Inc., effective January 22, 2024, which was filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 26, 2024, and is incorporated herein by reference thereto.
4.1   Form of Indenture
4.2**   Form of Certificate of Designation
4.3**   Form of Deposit Agreement
4.4**   Form of Depositary Agreement
4.5**   Form of Warrant Agreement
4.6**   Form of Warrant
4.7**   Form of Rights Agreement
4.8**   Form of Unit Agreement
5.1*   Opinion of Sichenzia Ross Ference Carmel LLP relating to the base prospectus
23.1*  

Consent of MaloneBailey, LLP

23.2*   Consent of Counsel to Registrant (included in Exhibit 5.1).
24.1*   Powers of Attorney (included on the signature page of Registration Statement)
25.1***   Form T-1 Statement of Eligibility to act as trustee under Indenture
107*   Filing Fees

 

* Previously filed.
   
** To be filed, if necessary, by post-effective amendment to this registration statement or as an exhibit to a current report of the registrant on Form 8-K and incorporated herein by reference.
   
*** To be filed separately pursuant to Section 305(b)(2) of the Trust Indenture Act of 1939 under the electronic form type 305B2.

 

II-3

 

  

Item 17. Undertakings

 

The undersigned registrant hereby undertakes:

 

(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

 

(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;

 

(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in this registration statement;

 

Provided, however, that Paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the registration statement is on Form S-3 or Form F-3 and the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

 

(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

(4) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

 

(i) If the registrant is relying on Rule 430B:

 

(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

 

(B) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415 (a)(1)(i), (vii) or (x) for the purpose of providing the information required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

II-4

 

 

Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

 

(5) That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:

 

The undersigned registrant undertakes that in an offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

(iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

 

(iv) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

 

The undersigned registrant hereby further undertakes that, for the purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933 and will be governed by the final adjudication of such issue.

 

The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of section 310 of the Trust Indenture Act (“Act”) in accordance with the rules and regulations prescribed by the Commission under section 305(b)(2) of the Act.

 

II-5

 

 

SIGNATURES

  

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Amendment No. 1 to the Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized in City of Grant, State of Florida, on July 11 2025.

 

Kaival Brands Innovations Group, Inc..  
   
By: /s/Mark Thoenes  
  Mark Thoenes  
 

Interim Chief Executive Officer

(Principal Executive Officer)

 

 

Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities and on the dates indicated.

 

    Name   Position   Date
         
/s/ Mark Thoenes   Interim Chief Executive Officer and Director   July 11, 2025 
Mark Thoenes   (Principal Executive Officer)    
         
/s/ *Eric Morris   Interim Chief Financial Officer   July 11, 2025 
Eric Morris   (Principal Accounting Officer)    
         
/s/ *David Worner   Director   July 11, 2025 
David Worner        
         
/s/ *Ketankumar Patel   Director   July 11, 2025 
Ketankumar Patel        
         
/s/ *Ashesh Modi   Director   July 11, 2025 
Ashesh Modi        

   

*Signed by Mark Thoenes, his attorney-in-fact.

 

II-6

 

 

FAQ

Why is BioVie (BIVI) conducting a public offering now?

To raise ≈ $14 M net for working capital and fund ongoing clinical programs after executing a 1-for-10 reverse split.

How much will the BioVie offering dilute existing shareholders?

Post-offering shares rise from 1.86 M to 3.32 M (up 78 %), plus 1.46 M 5-year warrants and possible over-allotment.

What is the exercise price and term of the new warrants (ticker BIVIW)?

Each warrant strikes at $12.875 (125 % of assumed $10.30 offer price) and expires five years after issuance.

Will the pre-funded warrants be tradeable?

No. Pre-funded warrants (exercise price $0.0001) will not be listed on any exchange and are expected to be illiquid.

How does the reverse stock split affect BioVie’s shares?

Every 10 pre-split shares became 1 new share on 7-7-25, boosting price above $5 but reducing the public float.

What are the key pipeline catalysts after this filing?

1) Resolution or redesign of the Alzheimer’s Phase 3 program; 2) Enrollment progress in the Phase 2b Parkinson’s trial; 3) ADDRESS-LC Long-COVID Phase 2 readouts; 4) Finalization of BIV201 Phase 3 protocol for ascites.

Does BioVie face any significant legal risks?

Yes. A consolidated securities class action (In re BioVie Inc.) is in discovery; defense costs up to $2 M are uninsured.
Kaival Brnds Innovatns Grp Inc

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