0001437749-23-030004.txt : 20231102 0001437749-23-030004.hdr.sgml : 20231102 20231102161119 ACCESSION NUMBER: 0001437749-23-030004 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231102 DATE AS OF CHANGE: 20231102 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Vaxart, Inc. CENTRAL INDEX KEY: 0000072444 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 591212264 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35285 FILM NUMBER: 231372411 BUSINESS ADDRESS: STREET 1: 170 HARBOR WAY, SUITE 300 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: (650) 550-3500 MAIL ADDRESS: STREET 1: 170 HARBOR WAY, SUITE 300 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 FORMER COMPANY: FORMER CONFORMED NAME: Aviragen Therapeutics, Inc. DATE OF NAME CHANGE: 20160413 FORMER COMPANY: FORMER CONFORMED NAME: Biota Pharmaceuticals, Inc. DATE OF NAME CHANGE: 20121113 FORMER COMPANY: FORMER CONFORMED NAME: NABI BIOPHARMACEUTICALS DATE OF NAME CHANGE: 20100719 8-K 1 vxrt20230824_8k.htm FORM 8-K vxrt20230824_8k.htm
false 0000072444 0000072444 2023-11-02 2023-11-02
 
 
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):  November 2, 2023
 
 
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.)
   
170 Harbor Way, Suite 300, South San Francisco, California
  
94080
(Address of principal executive offices)
  
(Zip Code)
 
Registrant’s 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)) 
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
  
Trading symbol
  
Name of each exchange on which registered
Common Stock, $0.0001 par value
  
VXRT
  
The Nasdaq Capital Market
 
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 2.02
Results of Operations and Financial Condition.
 
On November 2, 2023, Vaxart, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2023. A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
 
The information in this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying Exhibit 99.1 shall not be deemed incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Vaxart, Inc., whether made before or after the date hereof regardless of any general incorporation language in such filing.
 
 
Item 9.01
Financial Statements and Exhibits.
 
(d) Exhibits
 
     
Exhibit
  
Description
   
99.1
  
     
104
  
Cover Page Interactive Data File (embedded within Inline XBRL document)
 
 
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
       
Vaxart, Inc.
         
         
Dated: November 2, 2023
        
       
By:
  
/s/ ANDREI FLOROIU
  
           
Andrei Floroiu
           
President and Chief Executive Officer
 
 
 EX-99.1 2 ex_564419.htm EXHIBIT 99.1_ITEM 2.02 FINANCIAL RESULTS ex_564419.htm

 

Exhibit 99.1

Vaxart Provides Business Update and Reports Third Quarter 2023 Financial Results

 

 

 

Norovirus challenge study topline results indicate the potential of Vaxart's oral pill vaccine candidate to reduce rates of norovirus infection, norovirus acute gastroenteritis and viral shedding

Clinical proof of concept for the Company's oral pill vaccine platform now established in two human challenge studies for norovirus and influenza

Conference call today at 4:30 p.m. ET

 

SOUTH SAN FRANCISCO, Calif., November 2, 2023 — Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the third quarter of 2023.

 

“During the third quarter, we took important steps toward validating our mucosal vaccine platform with the release of topline data from two Phase 2 trials of our norovirus program,” said Andrei Floroiu, Vaxart’s Chief Executive Officer. “Data from our Phase 2 challenge study indicated that our monovalent norovirus candidate has the potential to reduce norovirus infection, norovirus acute gastroenteritis, and viral shedding and also stimulates norovirus-specific antibody responses and neutralizing antibodies.

 

“With the rise in norovirus infections this year, we believe the totality of our norovirus vaccine data highlights the potential to address this need and the significant disease burden that norovirus causes,” Floroiu added. “We are currently conducting additional analyses of our norovirus data with the objectives of defining the timing of a larger Phase 2b study and identifying ways to reduce the size and duration of a subsequent Phase 3 registration study.”

 

Recent Business Highlights

 

Norovirus Vaccine Developments

  ● In October 2023, Vaxart dosed the first subject in its Phase 1 clinical trial evaluating the Company’s oral pill norovirus vaccine candidate focused on lactating mothers. The study is designed to investigate immunity in the breastmilk of nursing mothers who have received vaccine.
  ● In October 2023, Vaxart senior management presented at the World Vaccine Congress Europe 2023 in Barcelona, Spain.
 

o

Dr. Sean Tucker, Vaxart’s Founder and Chief Scientific Officer, presented on transmission-blocking strategies via oral pill vaccination and mucosal immune induction.
 

o

 Dr. James F. Cummings, Vaxart’s Chief Medical Officer, discussed protection against norovirus infection from an oral pill vaccine candidate in humans.
 

●

In September 2023, Vaxart announced topline data from the Phase 2 challenge study of its monovalent norovirus oral pill vaccine candidate.
 

o

The study met five of six primary endpoints.
 

o

The results showed a statistically significant 29% relative reduction in the rate of norovirus infection, a 21% relative reduction in the rate of norovirus acute gastroenteritis that was not statistically significant, and an 85% relative reduction in viral shedding. The latter was a prespecified study endpoint in the vaccinated cohort compared with placebo.
 

o

Vaxart believes this reduction in shedding could potentially have an impact on transmission and have important public health benefits.
 

●

In July 2023, Vaxart reported preliminary positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate.
 

●

Vaxart now has demonstrated robust immunogenicity data in eight clinical trials including both young adults and elderly populations.
 

●

The Company’s norovirus oral vaccine candidate has shown an attractive safety profile in trials and has been well tolerated with no vaccine-related serious adverse events.

 

COVID-19 Vaccine Developments

 

●

 Vaxart continues to progress its COVID-19 vaccine program and believes the cross-reactivity of the current constructs suggests a pathway for developing a pan-betacoronavirus vaccine. The Company is assessing next steps.

 

Financial Results for the Three Months Ended September 30, 2023

 

●

Vaxart ended the third quarter of 2023 with cash, cash equivalents, restricted cash and marketable securities of $53.0 million, compared to $67.9 million as of June 30, 2023. The Company continues to anticipate it has cash runway into the third quarter of 2024.
 

●

 Vaxart reported a net loss of $17.4 million for the third quarter of 2023, compared to $29.3 million for the third quarter of 2022. Net loss per share for the third quarter of 2023 was $0.11 per share, compared to a net loss of $0.23 per share in the third quarter of 2022.
 

●

 Revenue for the third quarter of 2023 was $2.1 million, compared to no revenue in the third quarter of 2022. Revenue in the third quarter of 2023 was primarily from revenue recognized for work performed under Vaxart’s grant from the Bill & Melinda Gates Foundation and non-cash royalty revenue from increased sales of Inavir in Japan.
 

●

 Research and development expenses were $15.0 million for the third quarter of 2023, compared to $22.5 million for the third quarter of 2022. The decrease is primarily due to decreases in manufacturing costs, personnel related costs and clinical trial expenses related to our COVID-19 vaccine candidates, partially offset by increased depreciation expense.
 

●

General and administrative expenses were $4.9 million for the third quarter of 2023, compared to $7.0 million for the third quarter of 2022. The decrease is primarily due to a decrease in legal and professional fees, directors' and officers' insurance and personnel related costs, partially offset by an increase in personnel stock-based costs.

 

Conference Call

 

The Vaxart senior management team will host a conference call to discuss the business update and financial results for the third quarter of 2023 today, beginning at 4:30 p.m. ET.

 

The conference call can be accessed using the following information:

 

Webcast: Click here

Date: Thursday, November 2, 2023 – 4:30 p.m. ET

Domestic: 877-407-0832

International: 201-689-8433

Conference ID: 13741880

 

Investors may submit written questions in advance of the conference call to ir@vaxart.com.

 

A replay of the webcast will be available for 30 days on Vaxart’s website at www.vaxart.com following the conclusion of the event.

 

About Vaxart

 

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, and seasonal influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and constructs for oral vaccination using adenovirus and TLR3 agonists.

 

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 Vaxart's strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," “anticipate,” "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the 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 important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's 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, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's 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.

     

Contacts                

    

Vaxart Media Relations:  

Investor Relations:       

Mark Herr     

Andrew Blazier

Vaxart, Inc.  

Finn Partners

mherr@vaxart.com    

IR@Vaxart.com   

(203) 517-8957      

(646) 871-8486   

 

 

 

 
 

 

Vaxart, Inc.

Condensed Consolidated Balance Sheets

 

   

September 30,

    

December 31,

  
    2023       2022  
   

(Unaudited)

       (1)  
   

(in thousands)

  

Assets

                

Cash, cash equivalents and restricted cash (2)

   $ 33,238     $ 46,013  

Investments in marketable debt securities

     19,799       49,704  

Accounts receivable

     424       20  

Prepaid expenses and other assets

     4,522       7,282  

Property and equipment, net

     12,926       15,585  

Right-of-use assets, net

     25,753       25,715  

Intangible assets, net

     4,472       5,020  

Goodwill

     4,508       4,508  

Total assets

   $ 105,642       153,847  
                 

Liabilities and stockholders’ equity

                

Accounts payable

   $ 1,339     $ 5,514  

Deferred grant revenue

     79       2,000  

Accrued and other liabilities

     6,269       8,315  

Operating lease liability

     20,459       21,705  

Liability related to sale of future royalties

     5,975       5,716  

Total liabilities

     34,121       43,250  

Stockholders’ equity

     71,521       110,597  

Total liabilities and stockholders’ equity

   $ 105,642     $ 153,847  

 

(1)

Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2022, included on the Form 10-K filed with the Securities and Exchange Commission on March 15, 2023.
 

 

(2)

Cash, cash equivalents and restricted cash includes $79,000 and $2.0 million of restricted cash as of September 30, 2023 and December 31, 2022, respectively.

 

 
 

 

Vaxart, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

   

3 Months Ended September 30,

   

9 Months Ended September 30,

 
   

2023

    

2022

    

2023

    

2022

  
   

(in thousands, except share and per share amounts)

  
                                 

Revenue

   $ 2,101     $ —     $ 4,134     $ 85  

Operating expenses:

                                

Research and development

     15,002       22,466       53,437       60,595  

General and administrative

     4,921       6,960       17,144       22,939  

Total operating expenses

     19,923       29,426       70,581       83,534  

Loss from operations

     (17,822 )     (29,426 )     (66,447 )     (83,449 )

Other income (expense), net

     461       133       1,444       (340 )

Loss before income taxes

     (17,361 )     (29,293 )     (65,003 )     (83,789 )

Provision for income taxes

     39       16       87       51  

Net loss

   $ (17,400 )   $ (29,309 )   $ (65,090 )   $ (83,840 )

Net loss per share, basic and diluted

   $ (0.11 )   $ (0.23 )   $ (0.45 )   $ (0.66 )

Shares used in computing net loss per share, basic and diluted

     152,026,112       126,889,718       145,810,175       126,374,424  

  

 
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