Form 8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 27, 2019

 

Vaxart, Inc.

(Exact name of registrant as specified in its charter)

 






Delaware

 

001-35285

 

59-1212264

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)



290 Utah Ave. Suite 200

South San Francisco, California

 

94080

(Address of principal executive offices)

 

(Zip Code)

Registrants telephone number, including area code: (650) 550-3500

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 13(a) of the Exchange Act.

 



Item 8.01                          Other Events.

 

On March 27, 2019, Vaxart, Inc. issued a press release announcing the completion of dosing of the lead-in cohort in a bivalent norovirus vaccine Phase 1b clinical trial. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.

 


Item 9.01

Financial Statements and Exhibits.


(d) Exhibits.






Exhibit Number

 

Description

99.1*

 

Press release, dated March 27, 2019, titled “Vaxart Completes Dosing of the Lead-In Cohort in Bivalent Norovirus Vaccine Phase 1b Clinical Trial”.

*Filed herewith




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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.

 









 


 

Vaxart, Inc.





Dated: March 27, 2019

 


 







 


 

By:

 

/s/ WOUTER W. LATOUR, M.D.


 


 


 

Wouter W. Latour, M.D.


 


 


 

President and Chief Executive Officer




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Exhibit 99.1

Exhibit 99.1

[http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12801862&doc=3]

Vaxart Completes Dosing of the Lead-In Cohort in

Bivalent Norovirus Vaccine Phase 1b Clinical Trial


First Oral Norovirus GII.4 Tablet Vaccine Used in Clinical Trial


SOUTH SAN FRANCISCO, Calif., March 27, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced the completion of dosing of the lead-in cohort in the Phase 1b bivalent norovirus vaccine clinical trial with its oral norovirus GII.4 vaccine.  


The Vaxart bivalent norovirus vaccine consists of an oral norovirus GI.1 vaccine and an oral norovirus GII.4 vaccine administered concurrently by tablet. The bivalent norovirus Phase 1b trial consists of two parts, an open-label lead-in phase which has now been completed, and a randomized, double-blind, placebo-controlled phase which is expected to start in April, subject to final review by the FDA. Both portions of the trial are designed to evaluate safety and immunogenicity. The Company expects to receive topline data from the trial in the second half of 2019.


About Norovirus


Norovirus is recognized as a leading cause of acute gastroenteritis in the United States. It is a common intestinal infection that typically lasts three to five days and is marked by diarrhea, vomiting, abdominal cramps, nausea and sometimes fever. Symptoms can be more severe in older adults and young children and may lead to serious complications including death. Norovirus causes frequent and widespread outbreaks in the military, food industry, travel industry, child care facilities, elderly homes and healthcare facilities.


The U.S. Centers for Disease Control and Prevention (CDC) estimates that norovirus causes approximately 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among young children and older adults.  In a recent study by Johns Hopkins University and the CDC, researchers estimated the global economic impact of norovirus disease at $60 billion, $34 billion of which occurred in high income countries, including the United States, Europe and Japan.


About Vaxart


Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxarts vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer. Vaxarts vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tableted vaccines are easier to distribute and administer than injectable vaccines and have the potential to significantly increase vaccination rates. Vaxarts development programs include oral tablet vaccines that are designed to protect against norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, please visit www.vaxart.com.



Note Regarding Forward-Looking Statements


This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as believe, could, potential, will and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to the Vaxarts ability to develop and commercialize its product candidates and clinical results and trial data; the expected timing of the initiation of the second part of the Phase 1 bivalent norovirus vaccine clinical trial and the timing of expected receipt of top line data; and Vaxarts expectations with respect to the advantages it believes its oral vaccine platform can offer over  injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various factors could cause actual results or events to differ materially from these forward-looking statements, including Vaxarts ability to raise sufficient capital to fund the continued development of its product candidates and complete its planned studies and trials, that Vaxarts product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxarts product candidates may not achieve broad market acceptance; that Vaxart may experience manufacturing issues and delays; and other risks described in the Risk Factors sections of Vaxarts Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.


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CONTACT:


Carl Mauch

Stern Investor Relations

212-362-1200

vaxart@sternir.com