Scinai Immunotherapeutics Ltd. current report, 04 June 2023

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Business Context and Reporting Period

This Form 8-K was filed by BiondVax Pharmaceuticals Ltd. (not Scinai Immunotherapeutics Ltd.) on June 8, 2023, reporting events occurring on June 4, 2023. The Company is an emerging growth company incorporated in Israel, with its principal executive offices in Jerusalem. The filing details the entry into a Material Definitive Agreement regarding the development of VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17).

Key Financial Metrics

The filing does not provide specific revenue, profit, cash flow, margin, debt, or liquidity figures. The financial implications of the agreement are as follows:

  • Equity Issuance: The Company must issue 17,000 American Depositary Shares (ADSs) to the counterparties within 45 days of June 4, 2023.
  • Milestone Payments: Future payments are due upon achieving specific milestones, such as the submission of a New Drug Application (IND) and the initiation of clinical studies.
  • Royalties: The Company will pay percentage-based royalties on net sales of pharmaceutical products containing the licensed NanoAbs.
  • Extension Fees: The Company may extend development deadlines by paying EUR 500,000 per 12-month extension.

Material Changes

The primary material change is the execution of an exclusive worldwide license agreement with Max-Planck-Innovation GmbH (MI) and the University Medical Center Gottingen (UMG). This agreement grants BiondVax rights to develop and commercialize NanoAbs targeting IL-17 for all potential indications. No prior comparable period data is provided in this specific filing to assess year-over-year financial changes.

Guidance, Outlook, and Risks

Outlook and Timeline:

  • BiondVax plans to initiate a preclinical in vivo efficacy study in 2024.
  • The Company has a deadline of June 30, 2025, to submit an IND.
  • If the June 30, 2025 deadline is missed, the Company has 45 days to submit a development plan to achieve submission by June 30, 2026.
Risks and Contingencies:
  • Termination Risk: If the IND is not submitted by June 30, 2026 (or an extended date), the License Agreement will terminate prior to December 31, 2026.
  • Lock-up Period: Recipients of the 17,000 ADSs have agreed not to sell the shares until June 4, 2024.
Management Commentary:

The filing states that the description of the agreement is qualified by reference to the full text of the License Agreement, which will be filed as an exhibit to the periodic report for the period ended June 30, 2023.

Investor Verification Checklist

  • Verify the exact allocation of the 17,000 ADSs between MI and the trustee for UMG once notified.
  • Confirm the specific percentage-based royalty rates and milestone payment amounts in the full License Agreement exhibit.
  • Monitor the Company's progress toward the June 30, 2025 IND submission deadline.
  • Review the upcoming periodic report for the period ended June 30, 2023, for the full text of the agreement and updated financial statements.