Grant from the Bill & Melinda Gates Foundation
On November 18, 2022, Vaxart, Inc. (the “Company”) entered into a Grant Agreement (the “Grant Agreement”) with the Bill & Melinda Gates Foundation (“BMGF”), pursuant to which the Company expects to receive approximately $3.46 million (the “Grant”) to partially fund a new study of the Company’s oral pill norovirus vaccine candidate focused on protecting breastfeeding mothers and their infants (the “Study”). Under the Grant Agreement, the Company agreed to a global access commitment for use of its vaccine candidate, if proven effective and approved, in breastfeeding mothers from low- and middle-income countries. The Grant Agreement is set to expire on September 15, 2024. Receipt by the Company of the Grant is subject to all of the terms and conditions of the Grant Agreement.
On December 1, 2022, the Company issued a press release discussing the commencement of the Study and the Grant. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”) and incorporated by reference herein.
Notice Regarding Conclusion of SEC Inquiry
As previously disclosed, the Securities and Exchange Commission (the “SEC”) advised the Company that it was the subject of an informal, non-public fact-finding inquiry by the SEC (the “Inquiry”). Additional information regarding the Inquiry can be found in the Company’s prior filings, including the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and filed with the SEC on February 24, 2022.
On November 29, 2022, the Company’s legal counsel received a notice from the SEC (the “Notice”) stating: “We have concluded the investigation as to your client Vaxart, Inc. Based on the information we have as of this date, we do not intend to recommend an enforcement action by the Commission against Vaxart, Inc.” The Notice was provided under the guidelines set forth in the final paragraph of Securities Act Release No. 5310.
Forward-Looking Statements
Statements contained or incorporated by reference in this Form 8-K which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies are forward-looking statements. The words “believe,” “expect,” “intend,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date of this Current Report on Form 8-K. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, whether any or all of the funding from the Grant is received by the Company, the Company’s continuing contractual and common law indemnity obligations to current and former officers and directors, the Company’s continuing operating losses, the possibility that the Company’s product candidates may not be approved by the U.S. Food and Drug Administration or non-U.S. regulatory authorities, uncertainty of market acceptance if the Company eventually produces a commercially viable vaccine, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, the Company’s ability to meet anticipated clinical endpoints, commencement dates, and/or completion dates for clinical trials, competition, limited marketing and manufacturing experience, and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other filings with the SEC. The Company undertakes no obligation to publicly update or revise any forward-looking statements.