Novavax Files 8-K Report

TL;DR

Novavax filed an 8-K on Oct 16, 2024, expect more info soon.

AI Summary

On October 16, 2024, Novavax, Inc. filed an 8-K report detailing a Regulation FD Disclosure and Other Events. The filing also includes financial statements and exhibits, but specific financial details or significant events beyond the filing itself are not elaborated upon in the provided text.

Why It Matters

This filing indicates Novavax is providing updated information to the SEC, which could include material disclosures relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard procedural disclosure and does not contain specific negative or positive news.

Key Numbers

• 0-26770 — SEC File Number (Identifies Novavax's filing with the SEC)
• 22-2816046 — I.R.S. Employer Identification No. (Tax identification number for Novavax)

Key Players & Entities

• NOVAVAX, INC. (company) — Registrant
• October 16, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of Incorporation
• 240-268-2000 (phone_number) — Registrant's telephone number
• Gaithersburg, Maryland (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.01 — registered Common Stock, Par Value $0.01 per share NVAX The Nasdaq Global Se

Filing Documents

• tm2426249d1_8k.htm (8-K) — 33KB
• tm2426249d1_ex99-1.htm (EX-99.1) — 10KB
• tm2426249d1_ex99-1img001.jpg (GRAPHIC) — 13KB
• 0001104659-24-108950.txt ( ) — 234KB
• nvax-20241016.xsd (EX-101.SCH) — 3KB
• nvax-20241016_lab.xml (EX-101.LAB) — 33KB
• nvax-20241016_pre.xml (EX-101.PRE) — 22KB
• tm2426249d1_8k_htm.xml (XML) — 3KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On October 16, 2024, Novavax, Inc. ("Novavax") issued the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference. The information in Item 7.01 is being furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such filing. In addition, the contents of Novavax's website are not incorporated by reference into this Current Report on Form 8-K and you should not consider information provided on Novavax's website to be part of this Current Report on Form 8-K.

01. Other Events

Item 8.01. Other Events. On October 11, 2024, the U.S. Food and Drug Administration ("FDA") notified Novavax that the FDA has placed a clinical hold on Novavax's Investigational New Drug Application ("IND") for its COVID-19-Influenza Combination ("CIC") and standalone influenza vaccine candidates. The clinical hold is due to a spontaneous report of a serious adverse event ("SAE") of motor neuropathy in a single CIC Phase 2 trial participant outside of the U.S. who received the vaccine in January 2023. The trial completed in July 2023 and the participant reported the SAE in September 2024. The FDA indicated they will provide an official clinical hold letter to Novavax within 30 days. The clinical hold may impact the timing of the initiation of, and data for, the Phase 3 immunogenicity trial for its CIC and standalone influenza vaccine candidate. Cautionary Note Regarding Forward-Looking Statements This Current Report on Form 8-K includes forward-looking statements, including statements related to the potential resolution of the clinical hold placed on Novavax's IND for its CIC and standalone influenza vaccine candidates and the timing of the initiation of, and data for, the Phase 3 immunogenicity trial for Novavax's CIC and standalone influenza vaccine candidates. Generally, forward-looking "will," "would," "possible," "can," "estimate," "continue," "ongoing," "consider," "anticipate," "intend," "seek," "plan," "project," "expect," "should," "would," "aim," or "assume," the negative of these terms, or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking beliefs and expectations about the future of its business, future plans and strategies, projections, anticipated events and trend

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press release, dated October 16, 2024 104 Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

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. NOVAVAX, INC. Date: October 16, 2024 By: /s/ Mark J. Casey Name: Mark J. Casey Title: Executive Vice President, Chief Legal Officer and Corporate Secretary

View Full Filing

View this 8-K filing on SEC EDGAR