Kaival Brnds Innovatns Grp Inc SEC Filings

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.