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Table of Contents



 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2024

 

OR

 

 

 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                      to                     

 

Commission file number: 001-35285

 

  

Vaxart, Inc.

  

  

(Exact Name of Registrant as Specified in its Charter)

  

 

  

Delaware

  

59-1212264

  

  

(State or other jurisdiction of incorporation or organization)

  

(IRS Employer Identification No.)

  

 

  

170 Harbor Way, Suite 300South San Francisco, CA 94080

  

(650) 550-3500

  

  

(Address of principal executive offices, including zip code)

  

(Registrant’s telephone number, including area code)

  

 

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes ☑   No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes ☑   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☑

Smaller reporting company 

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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes    No ☑

 

The Registrant had 176,838,011 shares of common stock, $0.0001 par value, outstanding as of May 6, 2024.

 



 

 

 

 

FORM 10-Q

FOR THE QUARTER ENDED March 31, 2024

TABLE OF CONTENTS

 

 

   

Page

Part I

FINANCIAL INFORMATION

1
         
   

Item 1.

Financial Statements (Unaudited)

1
         
     

Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023

1
         
     

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2024 and 2023

2
         
     

Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2024 and 2023

3
         
     

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 2023

5
         
     

Notes to the Condensed Consolidated Financial Statements

6
         
   

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

18
         
   

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

27
         
   

Item 4.

Controls and Procedures

28
         
         

Part II

OTHER INFORMATION

29
         
   

Item 1.

Legal Proceedings

29
         
   

Item 1A.

Risk Factors

29
         
   

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

30
         
   

Item 3.

Defaults Upon Senior Securities

30
         
   

Item 4.

Mine Safety Disclosures

30
         
   

Item 5.

Other Information

30
         
   

Item 6.

Exhibits

31
         

SIGNATURES

  33

 

 

 

FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (this “Quarterly Report”) for the quarterly period ended March 31, 2024, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are subject to the “safe harbor” created by those sections, concerning our business, operations, and financial performance and condition as well as our plans, objectives, and expectations for business operations and financial performance and condition. Any statements contained herein that are not of historical facts may be deemed to be forward-looking statements. You can identify these statements by words such as “anticipate,” “assume,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “should,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business and the industry in which we operate and management’s beliefs and assumptions and are not guarantees of future performance or development and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this Quarterly Report may turn out to be inaccurate. Factors that could materially affect our business operations and financial performance and condition include, but are not limited to, those risks and uncertainties described herein under “Item 1A. Risk Factors.” and those described in our Annual Report on Form 10-K for the year ended December 31, 2023, under “Item 1A. Risk Factors.” You are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are based on information available to us as of the filing date of this Quarterly Report. Unless required by law, we do not intend to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise. You should, however, review the risk factors we describe in the reports we will file from time to time with the Securities and Exchange Commission (the “SEC”) after the date of this Quarterly Report.

 

This Quarterly Report also contains market data related to our business and industry. These market data include projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may harm our business, results of operations, financial condition and the market price of our common stock.

 

 

 

PART I FINANCIAL INFORMATION

 

Item 1.  Financial Statements

 

 

VAXART, INC.

 

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

  

March 31, 2024

  

December 31, 2023

 

Assets

        

Current assets:

        

Cash and cash equivalents 

 $26,735  $34,755 

Short-term investments

  9,929   4,958 

Accounts receivable

  556   3,008 

Prepaid expenses and other current assets

  7,064   2,815 
         

Total current assets

  44,284   45,536 
         

Property and equipment, net

  11,102   11,731 

Right-of-use assets, net

  23,753   24,840 

Intangible assets, net

  4,106   4,289 

Goodwill

  4,508   4,508 

Other long-term assets

  917   926 
         

Total assets

 $88,670  $91,830 
         

Liabilities and StockholdersEquity

        

Current liabilities:

        

Accounts payable

 $3,978  $1,584 

Other accrued current liabilities

  4,980   5,634 

Current portion of operating lease liability

  2,799   2,703 

Current portion of liability related to sale of future royalties

  2,360   3,803 
         

Total current liabilities

  14,117   13,724 
         

Operating lease liability, net of current portion

  16,691   17,385 

Liability related to sale of future royalties, net of current portion

  1,863   2,623 

Other long-term liabilities

  309   293 
         

Total liabilities

  32,980   34,025 
         

Commitments and contingencies (Note 8)

          
         

Stockholders’ equity:

        

Preferred stock: $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2024 and December 31, 2023

      

Common stock: $0.0001 par value; 250,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 177,187,965 shares issued and 176,523,042 shares outstanding as of March 31, 2024 and 153,959,853 shares issued and 153,452,833 shares outstanding as of December 31, 2023

  18   15 

Additional paid-in capital

  490,221   467,731 

Treasury stock at cost, 664,923 shares as of March 31, 2024 and 507,020 shares as of December 31, 2023

  (548)  (366)

Accumulated deficit

  (433,991)  (409,574)

Accumulated other comprehensive loss

  (10)  (1)
         

Total stockholders’ equity

  55,690   57,805 
         

Total liabilities and stockholders’ equity

 $88,670  $91,830 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

 

VAXART, INC.

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 

Revenue:

               

Non-cash royalty revenue related to sale of future royalties

  $ 585     $ 278  

Revenue from government contracts

    1,596        

Grant revenue

          397  
                 

Total revenue

    2,181       675  
                 

Operating expenses:

               

Research and development

    19,013       19,622  

General and administrative

    7,238       6,625  
                 

Total operating expenses

    26,251       26,247  
                 

Operating loss

    (24,070 )     (25,572 )
                 

Other income (expense):

               

Interest income

    503       642  

Non-cash interest expense related to sale of future royalties

    (804 )     (178 )

Other expense, net

    (1 )     (3 )
                 

Loss before income taxes

    (24,372 )     (25,111 )
                 

Provision for income taxes

    45       29  
                 

Net loss

  $ (24,417 )   $ (25,140 )
                 

Net loss per share - basic and diluted

  $ (0.14 )   $ (0.19 )
                 

Shares used to compute net loss per share - basic and diluted

    168,811,095       135,213,196  
                 

Comprehensive loss:

               

Net loss

  $ (24,417 )   $ (25,140 )

Unrealized (loss) gain on available-for-sale investments, net of tax

    (9 )     229  

Comprehensive loss

  $ (24,426 )   $ (24,911 )

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC.

 

 

Condensed Consolidated Statements of Stockholders’ Equity

For the Three Months Ended March 31, 2024

(In thousands, except share amounts)

(Unaudited)

 

                          

Accumulated

     
                  

Additional

      

Other

  

Total

 
  

Common Stock

  

Treasury Stock

  

Paid-in

  

Accumulated

  

Comprehensive

  

Stockholders’

 

Three Months Ended March 31, 2024

 

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

(Loss) Gain

  

Equity

 
                                 

Balances as of December 31, 2023

  153,959,853  $15   (507,020) $(366) $467,731  $(409,574) $(1) $57,805 
                                 

Issuance of common stock under the September 2021 ATM, net of offering costs of $227

  7,404,672   1         8,424         8,425 
                                 

Issuance of common stock under the 2024 Securities Purchase Agreement, net of offering costs of $55

  15,384,615   2         9,943         9,945 
                                 

Issuance of common stock upon exercise of stock options

  8,865            7         7 
                                 

Release of common stock for vested restricted stock units

  429,960                      
                                 

Repurchase of common stock to satisfy tax withholding

        (157,903)  (182)           (182)
                                 

Stock-based compensation

              4,116         4,116 
                                 

Unrealized loss on available-for-sale investments

                    (9)  (9)
                                 

Net loss

                 (24,417)     (24,417)
                                 

Balances as of March 31, 2024

  177,187,965  $18   (664,923) $(548) $490,221  $(433,991) $(10) $55,690 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC.

 

Condensed Consolidated Statements of Stockholders’ Equity

For the Three Months Ended March 31, 2023

(In thousands, except share amounts)

(Unaudited)

 

                         Accumulated  

 

 
                  

Additional

      Other  Total 
  

Common Stock

  

Treasury Stock

  

Paid-in

  

Accumulated

  Comprehensive  Stockholders’ 

Three Months Ended March 31, 2023

 

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  (Loss) Gain  Equity 
                                 

Balances as of December 31, 2022

  134,199,429  $13     $  $437,992  $(327,109) $(299) $110,597 
                                 

Issuance of common stock under the September 2021 ATM, net of offering costs of $103

  1,362,220   1         1,429         1,430 
                                 

Release of common stock for vested restricted stock units

  49,220                      
                                 

Repurchase of common stock to satisfy tax withholding

        (13,553)  (10)           (10)
                                 

Stock-based compensation

              2,647         2,647 
                                 

Unrealized gain on available-for-sale investments

                    229   229 
                                 

Net loss

                 (25,140)     (25,140)
                                 

Balances as of March 31, 2023

  135,610,869  $14   (13,553) $(10) $442,068  $(352,249) $(70) $89,753 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC.

 

 

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Cash flows from operating activities:

               

Net loss

  $ (24,417 )   $ (25,140 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation and amortization

    2,177       2,062  

Amortization of discount on investments, net

    (87 )     (144 )

Stock-based compensation

    4,116       2,647  

Non-cash interest expense related to sale of future royalties

    804       178  

Non-cash revenue related to sale of future royalties

    (3,007 )     (20 )

Change in operating assets and liabilities:

               

Accounts receivable

    2,452       (244 )

Prepaid expenses and other assets

    (4,240 )     1,067  

Accounts payable

    2,314       (270 )

Deferred grant revenue

          (397 )

Other accrued liabilities

    (1,303 )     (4,199 )
                 

Net cash used in operating activities

    (21,191 )     (24,460 )
                 

Cash flows from investing activities:

               

Purchases of property and equipment

    (131 )     (1,239 )

Purchases of investments

    (9,893 )      

Proceeds from maturities of investments

    5,000       26,700  
                 

Net cash (used in) provided by investing activities

    (5,024 )     25,461  
                 

Cash flows from financing activities:

               

Net proceeds from issuance of common stock through at-the-market facilities

    8,425       1,430  

Net proceeds from issuance of common stock through the 2024 Securities Purchase Agreement

    9,945        

Proceeds from issuance of common stock upon exercise of stock options

    7        

Shares acquired to settle employee tax withholding liabilities

    (182 )     (10 )
                 

Net cash provided by financing activities

    18,195       1,420  
                 

Net (decrease) increase in cash, cash equivalents and restricted cash

    (8,020 )     2,421  
                 

Cash, cash equivalents and restricted cash at beginning of the period

    34,755       46,013  
                 

Cash, cash equivalents and restricted cash at end of the period

  $ 26,735     $ 48,434  

 

 

Supplemental reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets:                

Cash and cash equivalents

  $ 26,735     $ 46,831  

Restricted cash

          1,603  

Cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows at the end of the period

  $ 26,735     $ 48,434  

 

 

Supplemental disclosure of non-cash investing and financing activity:

               

Operating lease liabilities arising from obtaining right-of-use assets

  $     $ 296  

Acquisition of property and equipment included in accounts payable and accrued expenses

  $ 151     $ 246  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 1.  Organization and Nature of Business

 

General 

 

Vaxart Biosciences, Inc. was originally incorporated in California in March 2004, under the name West Coast Biologicals, Inc. The Company changed its name to Vaxart, Inc. (“Private Vaxart”) in July 2007, and reincorporated in the state of Delaware. In February 2018, Private Vaxart completed a business combination with Aviragen Therapeutics, Inc. (“Aviragen”), pursuant to which Aviragen merged with Private Vaxart, with Private Vaxart surviving as a wholly-owned subsidiary of Aviragen (the “Merger”). Pursuant to the terms of the Merger, Aviragen changed its name to Vaxart, Inc. (together with its subsidiaries, the “Company” or “Vaxart”) and Private Vaxart changed its name to Vaxart Biosciences, Inc.

 

In January 2024, the Company entered into a securities purchase agreement (the “2024 Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-270671) (the “2023 Shelf Registration”). The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

 

On September 15, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “September 2021 ATM”), pursuant to which it may offer and sell, from time to time through sales agents, shares of its common stock having an aggregate offering price of up to $100 million. The Company filed a prospectus supplement with the SEC on September 16, 2021, a subsequent prospectus supplement with the SEC on May 9, 2023 and will pay sales commissions of up to 3.0% of gross proceeds from the sale of shares. In the three months ended March 31, 2024, 7,404,672 shares were issued and sold under the September 2021 ATM for gross proceeds of $8.7 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $8.4 million.

 

The Company’s principal operations are based in South San Francisco, California, and it operates in one reportable segment, which is the discovery and development of oral recombinant protein vaccines, based on its proprietary oral vaccine platform. 

 

NOTE 2.  Summary of Significant Accounting Policies

 

Basis of Presentation, Liquidity and Going Concern – The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the accounting and disclosure rules and regulations of the SEC assuming the Company will continue as a going concern. 

 

The Company is a clinical-stage biotechnology company with no product sales. Its primary source of capital is from the sale and issuance of common stock and common stock warrants. As of March 31, 2024, the Company had cash, cash equivalents and investments of $36.7 million. The Company’s cash, cash equivalents and investments are not sufficient to fund the Company’s planned operations for a period of 12 months from the date the financial statements are issued. The Company will be dependent upon raising additional capital through placement of its common stock, notes or other securities, borrowings, or entering into a partnership with a strategic party in order to implement its business plan.

 

Based on management's current plan, the Company expects to have enough cash runway into late fourth quarter of 2024. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, management’s plans include further reducing or delaying operating expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

The condensed consolidated balance sheet as of December 31, 2023, included in this filing, was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in consolidated financial statements have been condensed or omitted pursuant to these rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 14, 2024 (the “Annual Report”). Unless noted below, there have been no material changes to the Company’s significant accounting policies described in Note 2 to the consolidated financial statements included in the Annual Report. In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year or any future periods.

 

Basis of Consolidation – The unaudited condensed consolidated financial statements include the financial statements of Vaxart, Inc. and its subsidiaries. All significant transactions and balances between Vaxart, Inc. and its subsidiaries have been eliminated in consolidation.

 

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities in the financial statements and accompanying notes. Actual results and outcomes could differ from these estimates and assumptions.

 

Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents, available-for-sale investments and accounts receivable. The Company places its cash, cash equivalents and available-for-sale investments at financial institutions that management believes are of high credit quality. The Company is exposed to credit risk in the event of default by the financial institutions holding the cash and cash equivalents to the extent such amounts are in excess of the federally insured limits. Losses incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

 

The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer or sector and establishing a minimum allowable credit rating.

 

6

 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

Recent Accounting Pronouncements

 

The Company has reviewed all significant newly-issued accounting pronouncements that are not yet effective and concluded that they are either not applicable to its operations or their adoption is not expected to have a material impact on its financial position or results of operations.

 

NOTE 3.  Fair Value of Financial Instruments

 

Fair value accounting is applied for all financial assets and liabilities and nonfinancial assets and liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued liabilities that approximate fair value due to their relatively short maturities.

 

Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with inputs used to measure their fair values. The accounting guidance for fair value provides a framework for measuring fair value and requires certain disclosures about how fair value is determined. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance also establishes a three-level valuation hierarchy that prioritizes the inputs to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity.

 

The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:

 

Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

 

Level 2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

 

Level 3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

 

The following table sets forth the fair value of the Company’s financial assets that are measured on a recurring basis as of March 31, 2024 and  December 31, 2023 (in thousands):

 

  

Level 1

  

Level 2

  

Level 3

  

Total

 

March 31, 2024

                

Financial assets:

                

Money market funds

 $17,710  $  $  $17,710 

U.S. Treasury securities

     14,876      14,876 

Total assets

 $17,710  $14,876  $  $32,586 

 

  

Level 1

  

Level 2

  

Level 3

  

Total

 

December 31, 2023

                

Financial assets:

                

Money market funds

 $31,403  $  $  $31,403 

U.S. Treasury securities

     4,958      4,958 

Total assets

 $31,403  $4,958  $  $36,361 

 

The Company held no financial liabilities measured on a recurring basis as of  March 31, 2024 or December 31, 2023.

 

 

7

 
 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 4.  Balance Sheet Components

 

 

(a)

Cash, Cash Equivalents and Investments

 

Cash, cash equivalents and investments consisted of the following (in thousands):

 

  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

Cash Equivalents

  

Investments

 

March 31, 2024

                        

Cash at banks

 $4,078  $  $  $4,078  $4,078  $ 

Money market funds

  17,710         17,710   17,710    

U.S. Treasury securities

  14,886      (10)  14,876   4,947   9,929 

Total

 $36,674  $  $(10) $36,664  $26,735  $9,929 

 

  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and 

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

Cash Equivalents

  

Investments

 

December 31, 2023

                        

Cash at banks

 $3,352  $  $  $3,352  $3,352    

Money market funds

  31,403         31,403   31,403    

U.S. Treasury securities

  4,959      (1)  4,958      4,958 

Total

 $39,714  $  $(1) $39,713  $34,755  $4,958 

  

As of March 31,2024 and December 31, 2023, all investments were available-for-sale debt securities with remaining maturities of 12 months or less.

 

 

(b)

Accounts Receivable

 

Accounts receivable comprises royalties receivable of $0.6 million and $3.0 million as of March 31, 2024 and December 31, 2023, respectively. The Company has provided no allowance for credit losses as of March 31, 2024 and December 31, 2023, based on past events and subsequent receipts.

 

 

(c)

Prepaid Expenses and Other Current Assets

 

Prepaid expenses and other current assets consists of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Prepaid clinical and manufacturing expenses

 $1,762  $984 

Unbilled revenue from government contracts

  

1,596

    
Prepaid insurance  933   258 
Prepaid rent  528   488 
Interest receivable  140   127 
Other  2,105   958 

Prepaid expenses and other current assets

 $7,064  $2,815 

 

 

(d)

Property and Equipment, Net

 

Property and equipment, net consists of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Laboratory equipment

 $13,507  $13,448 

Office and computer equipment

  1,105   1,105 

Leasehold improvements

  3,998   3,985 

Construction in progress

  226   24 

Total property and equipment

  18,836   18,562 

Less: accumulated depreciation

  (7,734)  (6,831)

Property and equipment, net

 $11,102  $11,731 

 

Depreciation expense was $0.9 million for the three months ended March 31, 2024 and 2023. There were no impairments of the Company’s property and equipment recorded in the three months ended March 31, 2024 or 2023.

 

8

 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

 

(e)

Right-of-Use Assets, Net

 

Right-of-use assets, net comprises facilities of $23.8 million and $24.8 million as of March 31, 2024 and December 31, 2023, respectively. The right-of-use of additional leased premises in California commenced in 2023, resulting in an additional $3.1 million right-of-use assets recorded in the year ended December 31, 2023.

 

 

(f)

Intangible Assets, Net

 

Intangible assets comprise developed technology and intellectual property. Intangible assets are carried at cost less accumulated amortization. As of March 31, 2024, developed technology and intellectual property had remaining lives of 5.6 and 3.75 years, respectively. As of March 31, 2024, there have been no indicators of impairment. Intangible assets consist of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Developed technology

 $5,000  $5,000 

Intellectual property

  80   80 

Total cost

  5,080   5,080 

Less: accumulated amortization

  (974)  (791)

Intangible assets, net

 $4,106  $4,289 

  

Intangible asset amortization expense was $0.2 million for the three months ended March 31, 2024 and 2023.

 

As of March 31, 2024, the estimated future amortization expense by year is as follows (in thousands):

 

Year Ending December 31,

 

Amount

 

2024 (nine months remaining)

 $548 

2025

  732 

2026

  731 

2027

  731 

2028

  727 

Thereafter

  637 

Total

 $4,106 

 

 

(g)

Goodwill

 

Goodwill, which represents the excess of the purchase price over the fair value of assets acquired, comprises $4.5 million as of March 31, 2024 and December 31, 2023. As of March 31, 2024, there have been no indicators of impairment.

 

 

(h)

Other Accrued Current Liabilities

 

Other accrued current liabilities consist of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Accrued compensation

 $3,199  $4,576 

Accrued clinical and manufacturing expenses

  180   312 

Accrued professional and consulting services

  707   211 

Other liabilities, current portion

  894   535 

Total

 $4,980  $5,634

 

 

9

 
 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 5.  Revenue

 

Royalty Revenue Related to Sale of Future Royalties

 

The Company generates royalty revenue from the sale of Inavir in Japan, pursuant to a collaboration and license agreement that Aviragen entered into with Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) in 2009. In September 2010, laninamivir octanoate was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children, which Daiichi Sankyo markets as Inavir. Under the agreement, the Company currently receives a 4% royalty on net sales of Inavir in Japan. Based on information provided by Daiichi Sankyo, the Company believes the expiration of the last patent related to Inavir is in  August 2036, at which time royalty revenue will cease. The Company’s royalty revenue is seasonal, in line with the flu season, so the majority of the Company’s royalty revenue and non-cash royalty revenue related to the sale of future royalties are earned in the first and fourth fiscal quarters. The royalty revenue related to Inavir recognized for the three months ended March 31, 2024 and 2023, was zero. The Company recognized non-cash royalty revenue related to sale of future royalties of $0.6 million and $0.3 million for the three months ended March 31, 2024 and 2023, respectively (see Note 6). Both royalty revenue and the non-cash royalty revenue related to the sale of future royalties are subject to a 5% withholding tax in Japan, for which $29,000 and $14,000 was included in income tax expense for the three months ended March 31, 2024 and 2023, respectively.

 

Revenue from Government Contracts

 

On January 12, 2024, the Company was awarded a contract (the “2024 ASPR-BARDA Contract”) by the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Administration for Strategic Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, the Company received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare the Company’s XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. The Company accounts for the 2024 ASPR-BARDA Contract under Accounting Standards Codification 958-605 and recognizes revenue as donor-imposed conditions are met. The Company recognized revenue from government contracts of $1.6 million for the three months ended March 31, 2024, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract. Unbilled revenue from government contracts was $1.6 million as of March 31, 2024.

 

Grant Revenue

 

In  November 2022, the Company accepted a $3.5 million grant to perform research and development work for the Bill & Melinda Gates Foundation (the “BMGF Grant”) and received $2.0 million in advance that was recorded as restricted cash and deferred revenue. The Company received an additional $1.5 million in  July 2023 upon completion of certain milestones. The Company recognizes revenue under research contracts only when a contract is executed and the contract price is fixed or determinable. Revenue from the BMGF Grant was recognized in the period during which the related costs were incurred and the related services rendered, as the applicable conditions under the contract were met. Costs of contract revenue were recorded as a component of operating expenses in the consolidated statements of operations and comprehensive loss. The Company recognized revenue from the BMGF Grant of zero and $0.4 million for the three months ended March 31, 2024 and 2023, respectively. The Company fully recognized revenue from the BMGF Grant during the year ended December 31, 2023.

 

 

10

 
 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 6.  Liabilities Related to Sale of Future Royalties

 

In April 2016, Aviragen entered into a Royalty Interest Acquisition Agreement (the “RIAA”) with HealthCare Royalty Partners III, L.P. (“HCRP”). Under the RIAA, HCRP made a $20.0 million cash payment to Aviragen in consideration for acquiring certain royalty rights (“Royalty Rights”) related to the approved product Inavir in the Japanese market. The Royalty Rights were obtained pursuant to the collaboration and license agreements (the “License Agreement”) and a commercialization agreement that the Company entered into with Daiichi Sankyo. Per the terms of the RIAA, during the first royalty interest period of April 1, 2016 through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by the Company. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount, plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by the Company. A shortfall occurs when, during an annual period ending on  March 31st, for the first royalty interest period of April 1, 2016 through March 31, 2025, the Company’s royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there shall remain any cumulative remaining shortfall amount as of December 24, 2029, any royalties received from Daiichi Sankyo subsequently by the Company would be payable to HCRP until the cumulative remaining shortfall amount has been paid.

 

For avoidance of doubt, the RIAA states, in the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, the Company shall not be obligated to pay HCRP any royalty payment beyond what the Company is paid from Daiichi Sankyo. The cumulative remaining shortfall amount is the aggregate amount of the remaining shortfall for each annual period, which was $6.0 million and $7.0 million as of March 31, 2024 and December 31, 2023, respectively.

 

Under the relevant accounting guidance, due to a limit on the amount of royalties that HCRP can earn under the RIAA, this transaction was accounted for as a liability that is being amortized using the effective interest method over the life of the arrangement. The Company has no obligation to pay any amounts to HCRP other than to pass through to HCRP its share of royalties as they are received from Daiichi Sankyo. To record the amortization of the liability, the Company is required to estimate the total amount of future royalty payments to be received under the License Agreement and the payments that will be passed through to HCRP over the life of this agreement. Consequently, the Company imputes interest on the unamortized portion of the liability and records non-cash interest expense using an estimated effective interest rate. The royalties earned in each period that will be passed through to HCRP are recorded as non-cash royalty revenue related to sale of future royalties, with any excess not subject to pass-through being recorded as royalty revenue. When the pass-through royalties are paid to HCRP in the following quarter, the imputed liability related to sale of future royalties is commensurately reduced. The Company periodically assesses the expected royalty payments, and to the extent such payments are greater or less than the initial estimate, the Company adjusts the amortization of the liability and interest rate. As a result of this accounting, even though the Company does not retain HCRP’s share of the royalties, it will continue to record non-cash revenue related to those royalties until the amount of the associated liability, including the related interest, is fully amortized.

 

The following table shows the activity within the liability account during the three months ended March 31, 2024 (in thousands):

 

Total liability related to sale of future royalties, start of period

 $6,426 

Non-cash royalty revenue paid to HCRP

  (3,007)

Non-cash interest expense recognized

  804 

Total liability related to sale of future royalties, end of period

  4,223 

Current portion

  (2,360)

Long-term portion

 $1,863 

 

11

 
 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 7.  Leases

 

The Company has obtained the right of use for office and manufacturing facilities under six operating lease agreements with initial terms exceeding one year. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise.

 

In  September 2021, the Company executed a lease for a facility in South San Francisco, California, with an initial term expiring on  March 31, 2029. This lease has two separate components, one commenced in the third quarter of 2022 and the other in the first quarter of 2023, resulting in an additional right of use asset $15.0 million and $3.1 million, respectively.

 

As of March 31, 2024, the weighted average discount rate for operating leases with initial terms of more than one year was 9.8% and the weighted average remaining term of these leases was 4.9 years. Discount rates were determined using the Company’s marginal rate of borrowing at the time each lease was executed or extended.

 

The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities with initial terms of more than 12 months as of  March 31, 2024 (in thousands):

 

Year Ending December 31,

    

2024 (nine months remaining)

 $3,306 

2025

  4,511 

2026

  5,031 

2027

  5,207 

2028

  5,389 

Thereafter

  1,348 

Undiscounted total

  24,792 

Less: imputed interest

  (5,302)

Present value of future minimum payments

  19,490 

Current portion of operating lease liability

  (2,799)

Operating lease liability, net of current portion

 $16,691 

 

The Company is also required to pay for operating expenses related to the leased space. The operating expenses are incurred separately and were not included in the present value of lease payments. Operating lease expenses for the three months ended March 31, 2024 and 2023, are summarized as follows (in thousands):

 

  

Three Months Ended March 31,

 
  

2024

  

2023

 

Lease cost

        

Operating lease cost

 $1,554  $1,510 

Short-term lease cost

  12   21 

Variable lease cost

  504   511 

Sublease income

  (14)   

Total lease cost

 $2,056  $2,042 

 

12

  
 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 8.  Commitments and Contingencies

 

 

(a)

Purchase Commitments

 

As of March 31, 2024, the Company had approximately $3.6 million of non-cancelable purchase commitments, principally for contract manufacturing and clinical services which are expected to be paid within the next year. In addition, the Company has operating lease commitments as detailed in Note 7.

 

 

(b)

Indemnifications

 

In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has also entered into indemnification agreements with certain officers and directors which provide, among other things, that the Company will indemnify and advance expenses incurred in connection with certain actions, suits or proceedings to such officer or director, under the circumstances and to the extent provided for therein, for expenses, damages, judgments, fines and settlements he or she may be required to pay in actions or proceedings which he or she is or may be made a party by reason of his or her position as a director, officer or other agent of the Company, and otherwise to the fullest extent permitted under Delaware law and the Company’s Bylaws. The Company currently has directors’ and officers’ insurance.

 

 

(c)

Litigation

 

From time to time the Company may be involved in legal proceedings arising in connection with its business. Based on information currently available, the Company believes that the amount, or range, of reasonably possible losses in connection with any pending actions against it in excess of established reserves, in the aggregate, is indeterminable to its consolidated financial condition or cash flows. However, any current or future dispute resolution or legal proceeding, regardless of the merits of any such proceeding, could result in substantial costs and a diversion of management’s attention and resources that are needed to run the Company successfully, and could have a material adverse impact on its business, financial condition and results of operations.

 

In August and September 2020, two substantially similar securities class actions were filed in the U.S. District Court for the Northern District of California. The first action, titled Himmelberg v. Vaxart, Inc. et al. was filed on August 24, 2020. The second action, titled Hovhannisyan v. Vaxart, Inc. et al. was filed on September 1, 2020 (together, the “Putative Class Action”). By Order dated September 17, 2020, the two actions were deemed related. On December 9, 2020, the court appointed lead plaintiffs and lead plaintiffs’ counsel.

 

On January 29, 2021, lead plaintiffs filed their consolidated amended complaint. On July 8, 2021, all defendants moved to dismiss the consolidated amended complaint. On May 14, 2021, the court granted lead plaintiffs’ request to amend the consolidated amended complaint and denied defendants’ motions to dismiss as moot. On June 10, 2021, lead plaintiffs filed a first amended consolidated complaint, and on August 9, 2021, lead plaintiffs filed a corrected first amended consolidated complaint. The first amended consolidated complaint, as corrected, named certain of Vaxart’s current and former executive officers and directors, as well as Armistice Capital, LLC (“Armistice”), as defendants. It claimed three violations of federal civil securities laws; violation of Section 10(b) of the Exchange Act and SEC Rule 10b-5, as against the Company and all individual defendants; violation of Section 20(a) of the Exchange Act, as against Armistice and all individual defendants; and violation of Section 20A of the Exchange Act against Armistice. The first amended consolidated complaint, as corrected, alleged that the defendants violated securities laws by misstating and/or omitting information regarding the Company’s development of a norovirus vaccine, the vaccine manufacturing capabilities of a business counterparty, and the Company’s involvement with Operation Warp Speed (“OWS”); and by engaging in a scheme to inflate Vaxart’s stock price. The first amended consolidated complaint sought certification as a class action for similarly situated shareholders and sought, among other things, an unspecified amount of damages and attorneys’ fees and costs. On July 8, 2021, all defendants moved to dismiss the first amended consolidated complaint. By Order dated December 22, 2021, the court granted the motion to dismiss by Armistice with leave to amend and otherwise denied the motions to dismiss. On July 27, 2022, lead plaintiffs filed a notice announcing that they had reached a partial settlement (the “Partial Settlement”) to resolve all claims against the Company and its current or former officers and/or directors in their capacity as officers and/or directors of the Company (the “Settling Defendants”). Pursuant to the Partial Settlement, the Company agreed to a settlement amount of $12.0 million with $2.0 million to be paid by the Company and the remainder to be paid by the Company’s insurers. On November 2, 2022, the Company paid the $2.0 million settlement amount with respect to the Putative Class Action pursuant to the terms of the settlement agreement reached in that case. On November 14, 2022, lead plaintiffs filed a second amended consolidated class action complaint that purported to include new allegations to support claims against Armistice. By Orders dated January 25, 2023, the court approved the Partial Settlement and entered judgment dismissing with prejudice all claims asserted in the Putative Class Action against the Settling Defendants.

 

On October 23, 2020, a complaint was filed in the U.S. District Court for the Southern District of New York, entitled Roth v. Armistice Capital LLC, et al. The complaint names Armistice and certain Armistice-related parties as defendants, asserting a violation of Exchange Act Section 16(b) and seeking the disgorgement of short-swing profits. The complaint purports to bring the lawsuit on behalf of and for the benefit of the Company and names the Company as a “nominal defendant” for whose benefit damages are sought. Following discovery, a motion for summary judgment was filed by Armistice and the Armistice-related party defendants to dismiss the complaint. On March 27, 2024, the court granted the motion for summary judgment and dismissed all claims in the complaint in their entirety. On April 11, 2024, the Plaintiff timely filed a notice of appeal of the court’s decision to the Second Circuit Court of Appeals, commencing appellate proceedings.

 

On January 8, 2021, a purported shareholder, Phillip Chan, commenced a pro se lawsuit in the U.S. District Court for the Northern District of California titled Chan v. Vaxart, Inc. et al. (the “Opt-Out Action”), opting out of the consolidated Himmelberg v. Vaxart, Inc. et al. and Hovhannisyan v. Vaxart, Inc. et al. class actions, (together, the “Putative Class Action”). Because this complaint is nearly identical to an earlier version of a complaint filed in the Putative Class Action, the Opt-Out Action has been stayed while the Putative Class Action is pending.

 

13

 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 9.  Stockholders’ Equity

 

 

(a)

Preferred Stock

 

The Company is authorized to issue 5,000,000 shares of preferred stock, $0.0001 par value per share. The Company’s board of directors may, without further action by the stockholders, fix the rights, preferences, privileges and restrictions of up to an aggregate of 5,000,000 shares of preferred stock in one or more series and authorize their issuance. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of our common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deterring or preventing a change of control or other corporate action. No shares of preferred stock are currently outstanding, and the Company has no present plan to issue any shares of preferred stock.

 

 

(b)

Common Stock

 

As of March 31, 2024, the Company was authorized to issue 250,000,000 shares of common stock, $0.0001 par value per share, which includes an increase of 100,000,000 on August 4, 2022, when the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to increase the number of authorized shares of common stock from 150,000,000 shares. Except as otherwise required by law or as otherwise provided in any certificate of designation for any series of preferred stock, the holders of common stock possess all voting power for the election of the Company’s directors and all other matters requiring stockholder action. Holders of common stock are entitled to one vote per share on matters to be voted on by stockholders. Holders of common stock are entitled to receive such dividends, if any, as may be declared from time to time by the Company’s board of directors at its discretion out of funds legally available therefor. In no event will any stock dividends or stock splits or combinations of stock be declared or made on common stock unless the shares of common stock at the time outstanding are treated equally and identically. As of March 31, 2024, no dividends had been declared by the board of directors.

 

In January 2024, the Company entered into the 2024 Securities Purchase Agreement with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the Company’s 2023 Shelf Registration. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

 

In the event of the Company’s voluntary or involuntary liquidation, dissolution, distribution of assets or winding-up, the holders of the common stock will be entitled to receive an equal amount per share of all the Company’s assets of whatever kind available for distribution to stockholders, after the rights of the holders of the preferred stock have been satisfied. There are no sinking fund provisions applicable to the common stock.

 

The Company had shares of common stock reserved for issuance as follows:

 

  

March 31, 2024

  

December 31, 2023

 
         

Options issued and outstanding

  21,843,566   17,938,726 

RSUs issued and outstanding

  3,313,997   2,126,373 

2019 Equity Incentive Plan available for future grant

  1,404,517   5,685,806 

2024 Inducement Award Plan available for future grant

  1,750,000    

Common stock warrants

  211,259   227,434 

2022 Employee Stock Purchase Plan available for issuance

  1,065,325   1,065,325 

Total

  29,588,664   27,043,664 

 

 

(c)

Warrants

 

The following warrants were outstanding as of March 31, 2024, all of which contain standard anti-dilution protections in the event of subsequent rights offerings, stock splits, stock dividends or other extraordinary dividends, or other similar changes in the Company’s common stock or capital structure, and none of which have any participating rights for any losses:

 

Securities into which warrants are convertible

 

Warrants Outstanding

  

Exercise Price

 

Expiration Date

          

Common Stock

  44,148  $1.10 

April 2024

Common Stock

  26,515  $1.375 

April 2024

Common Stock

  29,150  $2.50 

March 2025

Common Stock

  100,532  $3.125 

February 2025

Common Stock

  10,914  $22.99 

December 2026

Total

  211,259      

 

In April 2024, 70,663 of the warrants outstanding as of March 31, 2024, expired unexercised. In the event of a Fundamental Transaction (a transfer of ownership of the Company as defined in the warrant) within the Company’s control, the holders of the unexercised common stock warrants exercisable for $1.10 and $2.50 and those exercisable for $3.125 expiring in February 2025 shall be entitled to receive cash consideration equal to a Black-Scholes valuation, as defined in the warrant. If such Fundamental Transaction is not within the Company’s control, the warrant holders would only be entitled to receive the same form of consideration (and in the same proportion) as the holders of the Company’s common stock, hence these warrants are classified as a component of permanent equity.

 

14

 
 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

NOTE 10.  Equity Incentive Plans

 

On April 23, 2019, the Company’s stockholders approved the adoption of the 2019 Equity Incentive Plan (the “2019 Plan”), under which the Company is authorized to issue incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), other stock awards and performance awards that may be settled in cash, stock, or other property. The 2019 Plan is designed to secure and retain the services of employees, directors and consultants, provide incentives for the Company’s employees, directors and consultants to exert maximum efforts for the success of the Company and its affiliates, and provide a means by which employees, directors and consultants may be given an opportunity to benefit from increases in the value of the Company’s common stock. Following adoption of the 2019 Plan, all previous plans were frozen, and on forfeiture, cancellation and expiration, awards under those plans are not assumed by the 2019 Plan.

 

The aggregate number of shares of common stock authorized for issuance under the 2019 Plan was initially 1,600,000 shares, which was increased through an amendment to the 2019 Plan adopted by the Company’s stockholders (a “Plan Amendment”) on June 8, 2020, to 8,000,000, by a Plan Amendment on June 16, 2021, to 16,900,000, and by a Plan Amendment on August 4, 2022, to 28,900,000. Further amendments to the 2019 Plan to increase the share reserve would require stockholder approval. Awards that are forfeited or canceled generally become available for issuance again under the 2019 Plan. Awards have a maximum term of ten years from the grant date and may vest over varying periods, as specified by the Company’s board of directors for each grant.

 

On February 27, 2024, the Company's board of directors adopted the Vaxart, Inc. 2024 Inducement Award Plan (the “2024 Inducement Plan”). The 2024 Inducement Plan was adopted without stockholder approval pursuant to Nasdaq Listing Rule 5635(c)(4) and is administered by the Compensation Committee of the board of directors or the independent members of the board of directors. The board of directors reserved 3,000,000 shares of the Company’s common stock for issuance under the 2024 Inducement Plan, subject to adjustment as provided in the plan document. The terms of the 2024 Inducement Plan are substantially similar to the terms of the 2019 Plan, with the exception that incentive stock options may not be issued under the 2024 Inducement Plan and equity awards under the 2024 Inducement Plan (including nonqualified stock options, restricted stock, restricted stock units, and other stock-based awards) may be issued only to an employee who is commencing employment with the Company or any subsidiary or who is being rehired following a bona fide interruption of employment by the Company or any subsidiary, in either case if he or she is granted such award in connection with his or her commencement of employment and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary.

 

A summary of stock option and RSU transactions in the three months ended March 31, 2024, is as follows:

 

          

Weighted

      

Weighted

 
  

Shares

  

Number of

  

Option Average

  

Unvested

  

RSU Average

 
  

Available

  

Options

  

Exercise

  

RSU Shares

  

Grant Date

 
  

For Grant

  

Outstanding

  

Price

  

Outstanding

  

Fair Value

 
                     

Balance as of January 1, 2024

  5,685,806   17,938,726  $2.90   2,126,373  $1.37 

Authorized under 2024 Inducement Plan

  

3,000,000

                 

Granted

  (6,555,730)  

4,734,937

  $1.16   1,820,793  $1.16 

Exercised

      (8,865) $0.78         

Released

              (429,960) $1.27 

Forfeited

 

 

981,822

   (778,613) $2.40   (203,209) $1.75 

Canceled

  42,619   (42,619) $3.35         
                     

Balance as of March 31, 2024

  3,154,517   21,843,566  $2.54   3,313,997  $1.24 

 

As of March 31, 2024, there were 21,843,566 options outstanding with a weighted average exercise price of $2.54, a weighted average remaining term of 7.58 years and an aggregate intrinsic value of $4.4 million. Of these options, 11,444,731 were vested, with a weighted average exercise price of $3.02, a weighted average remaining term of 6.15 years and an aggregate intrinsic value of $2.2 million. 

 

The Company received $7,000 for the 8,865 options exercised during the three months ended March 31, 2024, which had an intrinsic value of $3,000. There were no options exercised during the three months ended March 31, 2023. The aggregate intrinsic value represents the total pre-tax value (i.e., the difference between the Company’s stock price and the exercise price) of stock options outstanding as of March 31, 2024, based on the Company’s common stock closing price of $1.30 on March 28, 2024, the prior business day, which would have been received by the option holders had all their in-the-money options been exercised as of that date.

 

The weighted average grant date fair value of options awarded in the three months ended March 31, 2024 and 2023, was $1.04 and $0.78, respectively. Their fair values were estimated using the following assumptions:

 

  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Risk-free interest rate

  4.4%  3.5% - 3.6%

Expected term (in years)

  6.00   6.00 

Expected volatility

  129.1%  128.0%

Dividend yield

  %  %

 

15

 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

The Company measures the fair value of all stock-based awards on the grant date and records the fair value of these awards, net of estimated forfeitures, to compensation expense over the service period. Total stock-based compensation recognized for options, RSUs and ESPP was as follows (in thousands):

 

  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Research and development

 $1,807  $1,372 

General and administrative

  2,309   1,275 

Total stock-based compensation

 $4,116  $2,647 

 

As of March 31, 2024, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $21.9 million, which the Company expects to recognize over an estimated weighted average period of 2.59 years.

 

On August 4, 2022, the 2022 Employee Stock Purchase Plan (the “2022 ESPP”) was approved by the Company’s stockholders. The Company reserved 1,800,000 shares of the Company’s common stock for purchase under the 2022 ESPP. The 2022 ESPP has a six-month offering period comprised of one purchase period. The purchase price of the stock is equal to 85% of the lesser of the market value of such shares at the beginning of the six-month offering period or the end of such offering period. During the three months ended March 31, 2024, the Company did not issue any shares under the 2022 ESPP. As of March 31, 2024, 1,065,325 shares are available and reserved for future issuance under the 2022 ESPP.

 

The estimated fair value used for the six-month offering period beginning December 1, 2023 and ending May 31, 2024, was $0.27 per share. The estimated fair value used for the six-month offering period beginning December 1, 2022 and ending May 31, 2023, was $0.46 per share. As of March 31, 2024, the unrecognized stock-based compensation cost related to the outstanding 2022 ESPP offering period expected to be recognized by May 31, 2024, is $42,000. The fair value of the 2022 ESPP shares was estimated using the Black-Scholes option pricing model using the following assumptions:

 

  

Six-Month Offering Period Ending May 31, 2024

  

Six-Month Offering Period Ended May 31, 2023

 
         

Risk-free interest rate

  5.3%  4.6%

Expected term (in years)

  0.50   0.50 

Expected volatility

  75.2%  84.7%

Dividend yield

  %  %

 

 

NOTE 11.  Net Loss Per Share Attributable to Common Stockholders

 

The following table presents the calculation of basic and diluted net loss per share (in thousands, except share and per share amounts):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Net loss

  $ (24,417 )   $ (25,140 )
                 

Shares used to compute net loss per share – basic and diluted

    168,811,095       135,213,196  
                 

Net loss per share – basic and diluted

  $ (0.14 )   $ (0.19 )

 

No adjustment has been made to the net loss in the three months ended March 31, 2024 and 2023, as the effect would be anti-dilutive due to the net loss.

 

The following potentially dilutive weighted average securities were excluded from the computation of weighted average shares outstanding because they would have been antidilutive:

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Options to purchase common stock

    18,034,438       14,436,046  
                 

Restricted stock units to purchase common stock

    1,977,053       1,218,200  
                 

Warrants to purchase common stock

    211,259       227,434  
                 

Employee Stock Purchase Plan

    471,638       433,328  
                 

Total potentially dilutive securities excluded from denominator of the diluted earnings per share computation

    20,694,388       16,315,008  
 

 

16

 

VAXART, INC.

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

Note 12. Subsequent Events

 

Since March 31, 2024, the Company has issued 314,969 shares of common stock under the September 2021 ATM (see Note 1) for gross proceeds net of commissions totaling $0.4 million through the filing date of this Quarterly Report on Form 10-Q.

 

17

 
 

Item 2.  Managements Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with our audited consolidated financial statements included in our Annual Report on Form 10-K filed with the SEC on March 14, 2024. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “goal,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements and reflect our beliefs and opinions on the relevant subject. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and in this Quarterly Report on Form 10-Q. The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof. These statements are based upon information available to us as of the filing date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and we caution investors against unduly relying upon these statements. In all events, we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, change in circumstances, future events or otherwise, and you are advised to consult any additional disclosures that we may make directly to you or through reports that we, in the future, may file with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K.

 

Company Overview and Background

 

We are a clinical-stage biotechnology company primarily focused on the development of oral recombinant vaccines based on our Vector-Adjuvant-Antigen Standardized Technology (“VAAST”) proprietary oral vaccine platform. We are developing prophylactic vaccine candidates that target a range of infectious diseases, including norovirus (a widespread cause of acute gastroenteritis), coronavirus including SARS-CoV-2 (the virus that causes coronavirus disease 2019 (“COVID-19”)), and influenza. In addition, we have generated preclinical data for our first therapeutic vaccine candidate targeting cervical cancer and dysplasia caused by human papillomavirus (“HPV”). Our oral vaccines are designed to generate broad and durable immune responses that may protect against a wide range of infectious diseases and may be useful for the treatment of chronic viral infections and cancer. Our investigational vaccines are administered using a room temperature-stable tablet, rather than by injection. 

 

Vaxart Biosciences, Inc. was originally incorporated in California under the name West Coast Biologicals, Inc. in March 2004 and changed its name to Vaxart, Inc. (“Private Vaxart”) in July 2007, when it reincorporated in the state of Delaware. On February 13, 2018, Private Vaxart completed a reverse merger (the “Merger”) with Aviragen Therapeutics, Inc. (“Aviragen”), pursuant to which Private Vaxart survived as a wholly owned subsidiary of Aviragen. Under the terms of the Merger, Aviragen changed its name to Vaxart, Inc. and Private Vaxart changed its name to Vaxart Biosciences, Inc.

 

 

Our Product Pipeline

 

Figure 1. The following table outlines the status of our oral vaccine development programs:

 

a01.jpg
 

We are developing the following tablet vaccine candidates, which are all based on our proprietary platform:

 

 

Norovirus Vaccine. Norovirus is the leading cause of acute gastroenteritis symptoms, such as vomiting and diarrhea, among people of all ages in the United States. Each year, on average in the United States, norovirus causes 19 to 21 million cases of acute gastroenteritis and contributes to 109,000 hospitalizations and 900 deaths, mostly among young children and older adults. Virtually all norovirus disease is caused by norovirus GI and GII genotypes, and we are developing a bivalent vaccine candidate designed to protect against both.

 

In September 2023, we announced that our Phase 2 GI.1 norovirus challenge study evaluating the safety, immunogenicity, and clinical efficacy of the GI.1 component of our bivalent norovirus vaccine candidate met five of six primary endpoints based on preliminary topline data. The study achieved its primary endpoints of a statistically significant 29% relative reduction in the rate of norovirus infection between the vaccinated and placebo arms, a strong induction of norovirus-specific immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies, and other immune response endpoints. Vaccination also led to a 21% relative reduction in norovirus acute gastroenteritis in the vaccine arm compared to placebo, but this was not statistically significant. In prespecified analyses, the study also showed an 85% relative decrease in viral shedding in the vaccine arm compared with placebo and no statistically significant difference in disease severity in the vaccinated cohort compared with placebo. The vaccine candidate was also safe and well tolerated with no vaccine-related serious adverse events.

 

In July 2023, we announced our Phase 2 placebo-controlled dose-ranging trial evaluating the safety and immunogenicity of our bivalent norovirus vaccine candidate met all primary endpoints and our bivalent norovirus vaccine candidate was well-tolerated with robust immunogenicity based on preliminary topline data. Preliminary results showed robust increases in serum antibody responses across both doses at Day 29 relative to Day 1. Placebo subjects did not have a measurable increase in the antibody response. The vaccine candidate also had a favorable safety profile that included no vaccine-related serious adverse events and no dose limiting toxicity. Adverse event rates for both doses were similar to placebo.

 

We expect to meet with the Food and Drug Administration (“FDA”) in the middle of 2024 to discuss data on correlates of protection, which will inform potential next steps, such as conducting a Phase 2b study and potentially a GII.4 challenge study. We expect the Phase 2b study would generate sufficient safety data to enable us to have an end of Phase 2 meeting with the FDA. The end of Phase 2 meeting will allow us to gain concurrence on the scope and design of the Phase 3 pivotal efficacy study in adults over 18 years of age.

 

In the Fall of 2022, we announced a Phase 1 study that would receive significant funding and support from the Bill and Melinda Gates Foundation to evaluate whether our bivalent norovirus vaccine candidate induces antibodies in the breast milk of lactating mothers and whether infants up to six months of age can acquire those antibodies by breastfeeding. Passive transfer of antibodies from mother to infant that are induced in milk may protect breastfeeding infants from infectious pathogens. We initiated this study in the fourth quarter of 2023 and announced positive top line results in April 2024. Top line results showed antibodies rose in lactating mothers who received the high dose of our bivalent vaccine candidate. Specifically, serum antibodies to norovirus rose on average 5.6 fold in response to the GI.1 virus strain and 4.4 fold in response to the GII.4 virus strain and breast milk antibodies to norovirus rose on average 4.0 fold in response to the GI.1 virus strain and 6.0 fold in response to the GII.4 virus strain. The vaccine was well tolerated with no vaccine-related serious adverse events and no dose-limiting pharmacotoxicity. As a grant recipient from the Bill and Melinda Gates Foundation, Vaxart has agreed to a global access commitment for use of its bivalent norovirus vaccine candidate, if proven effective and approved, in breastfeeding mothers from low- and middle-income countries.

 

We have also created additional norovirus GI.1 and GII.4 constructs that may be more potent than the constructs being evaluated in clinical trials. Regulatory feedback from our FDA meeting in the middle of 2024, along with the clinical data on current constructs, and preclinical data generated on new constructs will assist us in determining the best way to progress our norovirus program.

 

 

Coronavirus Vaccine. COVID-19, a severe respiratory tract infection caused by the virus SARS-CoV-2, is a major cause of hospitalization and death in the U.S. and worldwide. According to the CDC, an outbreak of COVID-19 began in Wuhan, China, in late 2019 and rapidly spread worldwide. While most COVID-19 restrictions, such as stay-at-home orders, have been lifted, COVID-19 continues to spread and remains a public health threat, not least due to the continuing emergence of new variants.

 

 

In September 2022, we announced the results from the first part of a two-part Phase 2 clinical study evaluating the safety and immunogenicity of our oral COVID-19 (spike (“S”) protein only) vaccine candidate VXA-CoV2-1.1-S met both its primary and secondary endpoints based on topline data. VXA-CoV2-1.1-S was able to boost the serum antibody responses for volunteers that previously received an mRNA vaccine (either Pfizer/BioNTech or Moderna). Serum neutralizing antibody responses to SARS-CoV-2 (Wuhan), a recognized correlate of protection, were boosted in this population from a geometric mean of 481 to 778, a fold rise of 1.6. Volunteers that had lower starting titers had larger increases than subjects that had higher titers. There were also substantial increases in the neutralizing antibody responses to the SARS-CoV-2 Omicron BA4/5 in these volunteers as measured by sVNT assay. Increases in the mucosal IgA antibody responses (antibodies in the nose and mouth) were observed in approximately 50% of subjects. Subjects that had an increase in the mucosal IgA response to SARS-CoV-2 Wuhan S had an increase in IgA responses to other coronaviruses including SARS-CoV-2 Omicron BA4/5, SARS-CoV-1, and MERS-CoV, demonstrating the cross-reactive nature of these immune readouts. We are not proceeding with the second part of the study.

 

In February 2021, we announced our Phase 1 study evaluating the safety and immunogenicity of our oral COVID-19 (S and nucleocapsid (“N”) proteins) vaccine candidate VXA-CoV2-1 met both its primary and secondary endpoints based on preliminary data. Initial results showing cross-reactive mucosal antibody responses were published in Science Translational Medicine. Additional detailed study results and mucosal durability data were reported in medRxiv in July 2022.

 

We have made a COVID-19 vaccine candidate that expresses only the S protein from the SARS-CoV-2 XBB strain. Based on preclinical data, our XBB COVID-19 vaccine candidate is more potent than our prior COVID-19 vaccine constructs. In January 2024, we were awarded a contract (the “2024 ASPR-BARDA Contract”) by the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Administration for Strategic Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services, in an amount of $9.3 million to fund preparation for a Phase 2b clinical study involving 10,000 patients. This study will evaluate our XBB COVID-19 vaccine candidate compared to an approved mRNA vaccine comparator to measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events.

 

We expect to initiate the Phase 2b clinical trial as early as the second quarter of 2024.

 

 

Influenza Vaccine. Flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs. An estimated one billion cases of seasonal influenza occur annually worldwide, of which three to five million cases are considered severe, causing 290,000 to 650,000 deaths per year. In the United States, between 9,000,000 to 41,000,000 people catch influenza annually, between 140,000 and 710,000 people are hospitalized with complications of influenza, and between 12,000 and 52,000 people die from influenza and its complications each year.

 

In September 2018, we completed a $15.7 million contract with BARDA under which a Phase 2 challenge study of our H1N1 flu vaccine candidate was conducted. We announced that, in healthy volunteers immunized and then experimentally infected with H1 influenza, our H1 influenza oral tablet vaccine candidate reduced clinical disease by 39% relative to placebo. Fluzone, the market-leading injectable quadrivalent influenza vaccine, reduced clinical disease by 27%. Our tablet vaccine candidate also showed a favorable safety profile, indistinguishable from placebo.

 

In October 2018, we presented data from the study demonstrating that our vaccine candidate elicited a significant expansion of mucosal homing receptor plasmablasts to approximately 60% of all activated B cells. We believe these mucosal plasmablasts are a key indicator of a protective mucosal immune response and a unique feature of our vaccine candidates.

 

We have also initiated early-stage development on novel vaccine constructs containing our own antigens to develop a universal influenza vaccine candidate. We had previously produced a non-GMP oral vaccine candidate containing certain proprietary antigens from Janssen Vaccines & Prevention B.V. (“Janssen”) and tested the candidate in a preclinical challenge model. The preclinical study has been completed and we have submitted a report to Janssen. In August 2023, Janssen announced it would exit all vaccine and infectious disease R&D programs aside from an E. coli preventive vaccine and continuing to provide access to marketed HIV products.

 

The Company intends to work with governments around the world to create pandemic monovalent influenza vaccines for emergency use or stockpiling, if requested. We are also continuing development of our preclinical seasonal and universal influenza vaccine candidates.

 

 

HPV Therapeutic Vaccine. Cervical cancer is the fourth most common cancer in women worldwide and in the United States with about 13,000 new cases diagnosed annually in the United States according to the National Cervical Cancer Coalition. Our first therapeutic oral vaccine candidate targets HPV 16 and HPV 18, the two strains responsible for 70% of cervical cancers and precancerous cervical dysplasia.

 

We have tested our HPV 16 vaccine candidate in two different HPV 16 solid tumor models in mice. The HPV 16 vaccine candidate elicited T cell responses and promoted migration of the activated T cells into the tumors, leading to tumor cell killing. Mice that received our HPV 16 vaccine candidate showed a significant reduction in volume of their established tumors.

 

In October 2018, we filed a pre-IND meeting request with the FDA for our first therapeutic vaccine candidate targeting HPV 16 and HPV 18 and we subsequently submitted our pre-IND briefing package. We received feedback from the FDA in January 2019 to support submission of an IND application to support initiation of clinical testing.

 

The Company remains engaged in discussions with regulatory agencies, governments, non-governmental organizations and other potential strategic parties to determine the best way to progress its HPV program.

 

Antivirals

 

 

Through the Merger, we acquired two royalty earning products, Relenza and Inavir. We also acquired three Phase 2 clinical stage antiviral compounds and subsequently discontinued independent development of these compounds. However, for one of these, Vapendavir, we entered into an exclusive worldwide license agreement with Altesa Biosciences, Inc. (“Altesa”) in July 2021, permitting Altesa to develop and commercialize this capsid-binding broad-spectrum antiviral. In May 2022, Altesa announced its intention to initiate clinical trials.

 

 

Relenza and Inavir are antivirals for the treatment of influenza, marketed by GlaxoSmithKline, plc (“GSK”) and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”), respectively. We have earned royalties on the net sales of Relenza and Inavir in Japan. The last patent for Relenza expired in July 2019 and the last patent for Inavir expires in August 2036. Sales of these antivirals vary significantly by quarter, because influenza virus activity displays strong seasonal cycles, and by year depending on the intensity and duration of the flu season, the impact COVID-19 has had, and may continue to have, on seasonal influenza, and competition from other antivirals such as Tamiflu and Xofluza.

 

 

Financial Operations Overview

 

Revenue

 

Non-Cash Royalty Revenue Related to Sale of Future Royalties

 

In April 2016, Aviragen sold certain royalty rights related to Inavir in the Japanese market for $20.0 million to HealthCare Royalty Partners III, L.P. (“HCRP”). Under the terms of our agreement with HCRP, during the first royalty interest period of April 1, 2016 through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by us. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by us. A shortfall occurs when, during an annual period ending on March 31st, for the first royalty interest period of April 1, 2016 through March 31, 2025, royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, then, for so long as the Company continues to receive royalties from Daiichi Sankyo Company Limited (“Daiichi Sankyo”), the sum of those royalties will be paid to HCRP until the cumulative remaining shortfall amount has been paid in full. 

 

For avoidance of doubt, we are not obligated to pay HCRP any royalty payment beyond what we are paid by Daiichi Sankyo. The cumulative remaining shortfall amount is the aggregate amount of the shortfall for each annual period, which was $6.0 million as of March 31, 2024.

 

Revenue from Government Contracts

 

On January 12, 2024, we were awarded the 2024 ASPR-BARDA Contract providing for potential funding of up to $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. We recognized revenue from government contracts of $1.6 million for the three months ended March 31, 2024, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract.

 

Grant Revenue

 

In November 2022, we accepted a grant of $3.5 million to perform research and development work for the Bill & Melinda Gates Foundation (the “BMGF Grant”) and received $2.0 million in advance that was recorded as restricted cash and deferred revenue. We received an additional $1.5 million in July 2023 upon completion of certain milestones. We recognize revenue under research contracts only when a contract is executed and the contract price is fixed or determinable. Revenue from the BMGF Grant was recognized in the period during which the related costs were incurred and the related services rendered, as the applicable conditions under the contract were met. Costs of contract revenue were recorded as a component of operating expenses in the consolidated statements of operations and comprehensive loss. We fully recognized revenue from the BMGF Grant during the year ended December 31, 2023.

 

Research and Development Expenses

 

Research and development expenses represent costs incurred on conducting research, such as developing our tablet vaccine platform, and supporting preclinical and clinical development activities of our tablet vaccine candidates. We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:

 

 

employee-related expenses, which include salaries, benefits and stock-based compensation;

 

 

expenses incurred under agreements with contract research organizations (“CROs”), that conduct clinical trials on our behalf;

 

 

expenses incurred under agreements with contract manufacturing organizations (“CMOs”), that manufacture product used in the clinical trials;

 

 

expenses incurred in procuring materials and for analytical and release testing services required to produce vaccine candidates used in clinical trials;

 

 

process development expenses incurred internally and externally to improve the efficiency and yield of the bulk vaccine and tablet manufacturing activities

 

 

laboratory supplies and vendor expenses related to preclinical research activities;

 

 

consultant expenses for services supporting our clinical, regulatory and manufacturing activities; and

 

 

facilities, depreciation and allocated overhead expenses.

 

We do not allocate our internal expenses to specific programs. Our employees and other internal resources are not directly tied to any one research program and are typically deployed across multiple projects. Internal research and development expenses are presented as one total.


We have incurred significant external costs for CROs that conduct clinical trials on our behalf, and for CMOs that manufacture our tablet vaccine candidates, although these costs have decreased since 2022 since we now perform the majority of our manufacturing activities in-house. We have captured these external costs for each vaccine program. We do not allocate external costs incurred on preclinical research or process development to specific programs.

 


The following table shows our period-over-period research and development expenses, identifying external costs that were incurred in each of our vaccine programs and, separately, on preclinical research and process development (in thousands): 

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 

External program costs:

               

Norovirus program

  $ 1,002     $ 2,704  

COVID-19 program

    2,963       1,678  

Preclinical research

    723       465  

Process development

    35       520  

Total external costs

    4,723       5,367  

Internal costs

    14,290       14,255  

Total research and development

  $ 19,013     $ 19,622  

 

We expect to incur significant research and development expenses in 2024 and beyond as we advance our tablet vaccine candidates into and through clinical trials, pursue regulatory approval of our tablet vaccine candidates and prepare for a possible commercial launch, all of which will also require a significant investment in manufacturing and inventory related costs. To the extent that we enter into licensing, partnering or collaboration agreements, a significant portion of such costs may be borne by third parties.

 

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for our tablet vaccine candidates. The probability of successful commercialization of our tablet vaccine candidates may be affected by numerous factors, including clinical data obtained in future trials, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our tablet vaccine candidates.

 

General and Administrative Expense

 

General and administrative expenses consist of personnel costs, insurance, allocated expenses and expenses for outside professional services, including legal, audit, accounting, public relations, market research and other consulting services. Personnel costs consist of salaries, benefits and stock-based compensation. Allocated expenses consist of rent, depreciation and other facilities related expenses.

 

Results of Operations

 

The following table presents period-over-period changes in selected items in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023 (in thousands, except percentages):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

   

% Change

 
                         

Revenue

  $ 2,181     $ 675       *  
                         

Operating expenses

    26,251       26,247       0 %
                         

Operating loss

    (24,070 )     (25,572 )     (6) %
                         

Net non-operating income (expense)

    (302 )     461       *  
                         

Loss before income taxes

    (24,372 )     (25,111 )     (3) %
                         

Provision for income taxes

    45       29       55 %
                         

Net loss

  $ (24,417 )   $ (25,140 )     (3) %

 

* Percentages greater than 100% or not meaningful

 

 

Total Revenue 

 

The following table summarizes the period-over-period changes in our revenues for the three months ended March 31, 2024 and 2023 (in thousands, except percentages):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

   

% Change

 

Non-cash royalty revenue related to sale of future royalties

  $ 585     $ 278       *  

Revenue from government contracts

    1,596             100 %

Grant revenue

          397       (100 )%

Total revenue

  $ 2,181     $ 675       *  

 

* Percentages greater than 100% or not meaningful

 

Non-cash Royalty Revenue Related to Sale of Future Royalties

 

For the three months ended March 31,2024 and 2023, non-cash royalty revenue related to sale of future royalties from Daiichi Sankyo was $0.6 million and $0.3 million, respectively. We continue to have non-cash royalty revenue as all royalties received for the three months ended March 31, 2024 and 2023, were required to be paid to HCRP.

 

Revenue from Government Contracts

 

For the three months ended March 31, 2024 and 2023, revenue from government contracts was $1.6 million and zero, respectively. Revenue from government contracts related to the 2024 ASPR-BARDA Contract awarded to us in January 2024.

 

Grant Revenue

 

We recognized revenue from the BMGF Grant of zero and $0.4 million for the three months ended March 31, 2024 and 2023, respectively, as all research and development work under the contract was completed during the year ended December 31, 2023.

 

Total Operating Expenses

 

The following table summarizes the period-over-period changes in our operating expenses for the three months ended March 31, 2024 and 2023 (in thousands, except percentages):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

   

% Change

 

Research and development

  $ 19,013     $ 19,622       (3 )%

General and administrative

    7,238       6,625       9 %

Total operating expenses

  $ 26,251     $ 26,247       0 %

 

Research and Development

 

For the three months ended March 31,2024, research and development expenses decreased by $0.6 million, or 3%, compared to the three months ended March 31,2023. The decrease was primarily due to decreases in personnel related costs and clinical trial expenses related to our norovirus vaccine candidate, partially offset by increases in manufacturing costs, clinical trial costs related to our COVID-19 vaccine candidate and personnel stock-based expense.

 

General and Administrative

 

For the three months ended March 31, 2024, general and administrative expenses increased by $0.6 million, or 9%, compared to the three months ended March 31, 2023. The increase is primarily due to an increase in personnel stock-based expense and recruiting costs, partially offset by decreases in directors' and officers' insurance and legal fees. 

 

 

Non-Operating Income (Expense)

 

The following table summarizes the period-over-period changes in our non-operating income for the three months ended March 31, 2024 and 2023 (in thousands, except percentages):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

   

% Change

 

Interest income

  $ 503     $ 642       (22 )%

Non-cash interest expense related to sale of future royalties

    (804 )     (178 )     *  

Other expense, net

    (1 )     (3 )     (67 )%

Net non-operating income (expense)

  $ (302 )   $ 461       *  

 

* Percentages greater than 100% or not meaningful

 

For the three months ended March 31,2024, we recorded interest income of $0.5 million, a 22% decrease from the $0.6 million interest income recorded in the three months ended March 31,2023. The decrease is primarily due to a decrease in our cash, cash equivalents and investments balance.

 

Non-cash interest expense related to sale of future royalties representing imputed interest on the unamortized portion of the sale of future royalties liability, increased to $0.8 million for the three months ended March 31, 2024, from the $0.2 million for the three months ended March 31, 2023, due to an increase in non-cash royalty revenue payable to HCRP.

 

Provision for Income Taxes

 

The following table summarizes the period-over-period changes in our provision for income taxes for the three months ended March 31, 2024 and 2023 (in thousands, except percentages):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

   

% Change

 

Foreign withholding tax on royalty revenue

  $ 29     $ 14       *  

Foreign taxes payable on intercompany interest

    16       15       7 %

Provision for income taxes

  $ 45     $ 29       55 %

 

* Percentages greater than 100% or not meaningful

 

The provision for income taxes was $45,000 and $29,000 for the three months ended March 31, 2024 and 2023, respectively. The tax charge relates to interest on an intercompany loan from a foreign subsidiary and a 5% withholding tax on royalty revenue earned on sales of Inavir in Japan, which is potentially recoverable as a foreign tax credit but expensed because we record a 100% valuation allowance against our deferred tax assets. The amount of income tax expense recorded is directly proportional to Inavir royalties, including the portion that we pass through to HCRP.

 

Liquidity and Capital Resources

 

As of March 31, 2024, we had approximately $36.7 million of cash, cash equivalents and investments. Our primary source of financing is from the sale and issuance of common stock in public offerings. In the past, we have also obtained funds from the issuance of common stock warrants, secured debt and preferred stock and from collaboration agreements.

 

In September 2021, we entered into a Controlled Equity Offering Sales Agreement (the “September 2021 ATM”), under which we may offer and sell, from time to time through sales agents, shares of our common stock having an aggregate offering price of up to $100 million. We incur direct expenses and pay sales commissions of up to 3.0% of gross proceeds from the sale of shares under the September 2021 ATM. In the three months ended March 31, 2024, 7,404,672 shares were issued and sold under the September 2021 ATM for gross proceeds of $8.7 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $8.4 million. As of March 31, 2024, there was approximately $68.9 million in net proceeds still available to us under the September 2021 ATM. Since March 31, 2024, we issued 314,969 shares of common stock under the September 2021 ATM for gross proceeds net of commissions totaling $0.4 million through the filing date of this Quarterly Report on Form 10-Q.

 

In January 2024, we entered into a securities purchase agreement (the “2024 Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of our common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

 

In January 2024, we were awarded the 2024 ASPR-BARDA Contract with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. As of March 31, 2024, we have not received any cash payments under the 2024 ASPR-BARDA Contract. Subsequent to March 31, 2024, through the filing date of this Quarterly Report on Form 10-Q, we have received $1.6 million under the ASPR-BARDA Contract.

 

 

Our expectation is that we will continue to generate operating losses and negative operating cash flows in the future and the need for additional funding to support our planned operations raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that the financial statements are issued.

 

Management intends to complete additional financing transactions in the next 12 months. The sale of additional equity would result in additional dilution to our stockholders. We may fund a significant portion of our ongoing operations through partnering and collaboration agreements which, while reducing our risks and extending our cash runway, will also reduce our share of eventual revenues, if any, from our vaccine candidates. We may be able to fund certain activities with assistance from government programs. We may also fund our operations through debt financing, which would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations.

 

However, due to several factors, including those outside management’s control, there can be no assurance that the Company will be able to complete additional financing transactions. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, management’s plans include further reducing or delaying operating expenses.

 

Our future funding requirements will depend on many factors, including the following:

 

 

the timing and costs of our planned preclinical studies for our product candidates;

 

 

the timing and costs of our planned clinical trials of our product candidates;

 

 

our manufacturing capabilities, including the availability of contract manufacturing organizations to supply our product candidates at reasonable cost;

 

 

the amount and timing of royalties received on sales of Inavir;

 

 

the number and characteristics of product candidates that we pursue;

 

 

the outcome, timing and costs of seeking regulatory approvals;

 

 

revenue received from commercial sales of our future products, which will be subject to receipt of regulatory approval;

 

 

the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may enter into;

 

 

the amount and timing of any payments that may be required in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights;

 

 

our ability to stay listed on The Nasdaq Capital Market; and

 

 

the extent to which we in-license or acquire other products and technologies.

 

Cash Flows

 

The following table summarizes our cash flows for the periods indicated (in thousands):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Net cash used in operating activities

  $ (21,191 )   $ (24,460 )

Net cash (used in) provided by investing activities

    (5,024 )     25,461  

Net cash provided by financing activities

    18,195       1,420  
                 

Net (decrease) increase in cash, cash equivalents and restricted cash

  $ (8,020 )   $ 2,421  

 

Net Cash Used in Operating Activities

 

We experienced negative cash flow from operating activities for the three months ended March 31, 2024 and 2023, in the amounts of $21.2 million and $24.5 million, respectively. The cash used in operating activities in the three months ended March 31, 2024, was due to cash used to fund a net loss of $24.4 million and a decrease in working capital of $0.8 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, amortization of discount on investments, net, stock-based compensation, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $4.0 million. The cash used in operating activities in the three months ended March 31, 2023, was due to cash used to fund a net loss of $25.1 million and a decrease in working capital of $4.0 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, amortization of discount on investments, net, stock-based compensation, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $4.7 million.

 

 

Net Cash (Used in) Provided by Investing Activities

 

In the three months ended March 31, 2024, we used $4.9 million to purchase investments, net of maturities and used $0.1 million to purchase property and equipment. In the three months ended March 31, 2023, we received $26.7 million from maturities of investments, net of purchases, and used $1.2 million to purchase property and equipment.

 

Net Cash Provided by Financing Activities

 

In the three months ended March 31, 2024, we received net proceeds of $8.4 million from the sale of our common stock under the September 2021 ATM and net proceeds of $9.9 million from the sale of our common stock under the 2024 Securities Purchase Agreement, partially offset by $0.2 million from common stock acquired to settle employee tax withholding liabilities. In the three months ended March 31, 2023, we received $1.4 million from the sale of common stock under the September 2021 ATM.

 

Contractual Obligations and Commercial Commitments

 

We have the following contractual obligations and commercial commitments as of March 31, 2024 (in thousands):

 

Contractual Obligation

 

Total

   

< 1 Year

   

1 - 3 Years

   

3 - 5 Years

   

> 5 Years

 
                                         

Long Term Debt, HCRP

  $ 16,150     $ 665     $ 5,494     $ 5,520     $ 4,471  

Operating Leases

    24,792       3,306       9,542       10,596       1,348  

Purchase Obligations

    3,620       3,620                    

Total

  $ 44,562     $ 7,591     $ 15,036     $ 16,116     $ 5,819  

 

Long Term Debt, HCRP. Under an agreement executed in 2016, during the first royalty interest period of April 1, 2016 through March 31, 2025, we are obligated to pay HCRP the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by us. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by us. See Note 6 to the Condensed Consolidated Financial Statements in Part I, Item 1 for further details.

 

Operating leases. Operating lease amounts include future minimum lease payments under all our non-cancellable operating leases with an initial term in excess of one year. See Note 7 to the Condensed Consolidated Financial Statements in Part I, Item 1 for further details of leases.

 

Purchase obligations. These amounts include an estimate of all open purchase orders and contractual obligations in the ordinary course of business, including commitments with contract manufacturers and suppliers for which we have not received the goods or services. We consider all open purchase orders, which are generally enforceable and legally binding, to be commitments, although the terms may afford us the option to cancel based on our business needs prior to the delivery of goods or performance of services.

 

Share-based payment arrangements. Beginning in 2022, we shifted from awarding only options to issuing a mixture of options and restricted stock units (“RSUs”) to our employees. As of March 31, 2024, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $21.9 million, which the Company expects to recognize over an estimated weighted average period of 2.59 years. See Note 10 to the Condensed Consolidated Financial Statements in Part I, Item 1 for further details on stock-based compensation expense recognized.

 

Critical Accounting Policies and Estimates

 

Our management’s discussion and analysis of financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

 

Accrued Research and Development Expenses

 

We record accrued expenses for estimated costs of research and development activities conducted by third-party service providers, which include the conduct of preclinical studies and clinical trials, and contract manufacturing activities. We record the estimated costs of research and development activities based upon the estimated amount of services provided and include the costs incurred but not yet invoiced within other accrued liabilities in the consolidated balance sheets and within research and development expense in the consolidated statements of operations and comprehensive loss. These costs can be a significant component of our research and development expenses.

 

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates.

 

 

Intangible Assets

 

Intangible assets acquired in the Merger were initially recorded at their estimated fair values of $20.3 million for developed technology related to Inavir which was, until it was revalued, being amortized on a straight-line basis over the estimated period of future royalties of 11.75 years. The developed technology related to Inavir was revalued at $5.0 million as of December 31, 2022, resulting in an impairment loss of $4.3 million being recorded. These valuations were prepared with the assistance of an independent third party based on discounted cash flows of estimated future revenue streams, which are highly subjective. The fair value as of March 31, 2024, is being amortized on a straight-line basis over the remaining period of 5.6 years.

 

Stock-Based Compensation

 

We measure the fair value of all stock option awards to employees, non-executive directors and consultants on the grant date, and record the fair value of these awards, net of estimated forfeitures, as compensation expense over the service period. The fair value of options is estimated using the Black-Scholes valuation model and the expense recorded is affected by subjective assumptions regarding a number of variables, as follows:

 

Expected term – This represents the period that our stock-based awards granted are expected to be outstanding and is determined using the simplified method (the arithmetic average of its original contractual term and its average vesting term). We have very limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior for our stock-based awards. Based on the weighted average applied to options awarded in three months ended March 31, 2024, a notional 10% decrease in expected term would have reduced the fair value and the related compensation expense by approximately 2.1%.

 

Expected volatility – This is a measure of the amount by which our common stock price has fluctuated or is expected to fluctuate. Since the beginning of 2020, we have measured volatility based on the historical volatility of our own stock over the retrospective period corresponding to the expected term of the options on the measurement date. Based on the weighted average applied to options awarded in three months ended March 31, 2024, a notional 10% decrease in expected volatility (from 129.1% to 116.2%) would have reduced the fair value and the related compensation expense by approximately 4.0%.

 

Risk-free interest rate – This is based on the U.S. Treasury yield curve on the measurement date corresponding with the expected term of the stock-based awards.

 

Expected dividend – We have not made any dividend payments and do not plan to pay dividends in the foreseeable future. Therefore, we use an expected dividend yield of zero.

 

Forfeiture rate – This is a measure of the number of awards that are expected to not vest and is reassessed quarterly. An increase in the estimated forfeiture rate will cause a small decrease in the related compensation expense early in the service period, but since the final expense recorded for each award is the number of options vested times their grant date fair value, it has no impact on the total expense recorded.

 

Recent Accounting Pronouncements

 

See the “Recent Accounting Pronouncements” in Note 2 to the Condensed Consolidated Financial Statements in Part I, Item 1 for information related to the issuance of new accounting standards in the first three months of 2024, which are either not applicable to its operations or their adoption is not expected to have a material impact on our condensed consolidated financial statements.

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Interest Rate Sensitivity

 

Our exposure to market risk for changes in interest rates relates primarily to our investments in marketable debt securities. The primary objective of our investment activities is to preserve principal, maintain liquidity that is sufficient to meet cash needs and maximize total return without significantly increasing risk. To achieve this goal, we maintain our excess cash and cash equivalents in money market funds and marketable debt securities. We do not enter into investments for trading or speculative purposes and we hold no equity securities. We presently have no borrowings or lines of credit. 

 

Specifically, as of March 31, 2024, we had cash, cash equivalents and investments of approximately $36.7 million, which consist of bank deposits, money market funds and U.S. government securities. All of our investments must satisfy high credit rating requirements at the time of purchase. Such interest-earning instruments carry a degree of interest rate risk, however, because our investments are rated highly and mostly short-term, we believe that our exposure to risk of loss due to interest rate changes is not significant.

 

Exchange Rate Sensitivity

 

Our royalty revenue, which is calculated in U.S. dollars, is based on sales in Japanese yen, so a 1% increase in the strength of the U.S. dollar against the yen would lead to a 1% reduction in royalty revenue and related accounts receivable. All our other revenue and substantially all of our expenses, assets and liabilities are denominated in U.S. dollars and, as a result, we have not experienced significant foreign exchange gains or losses recently and do not anticipate that foreign exchange gains or losses will be significant in the near future.

 

 

Item 4.  Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal accounting and financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our management has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2024.

 

Changes in Internal Control over Financial Reporting

 

There was no material change in our internal control over financial reporting that occurred during the quarter ended March 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
 

Inherent Limitations on Effectiveness of Controls

 

Our management, including our principal executive officer and principal accounting and financial officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Vaxart have been detected.

 

 

PART II OTHER INFORMATION

 

 

Item 1.  Legal Proceedings

 

The information included in “Note 8. Commitments and Contingencies—(c) Litigation” to the Condensed Consolidated Financial Statements in Part I, Item 1 is incorporated by reference into this Item.

 

We may also from time to time be involved in legal proceedings arising in connection with our business. Based on information currently available, we believe that the amount, or range, of reasonably possible losses in connection with any pending actions against us in excess of established reserves, in the aggregate, is not material to our consolidated financial condition or cash flows. However, any current or future dispute resolution or legal proceeding, regardless of the merits of any such proceeding, could result in substantial costs and a diversion of management’s attention and resources that are needed to run our business successfully, and could have a material adverse impact on our business, financial condition and results of operations.

 

 

Item 1A.  Risk Factors

 

You should consider the risks and uncertainties described under Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which we filed with the Securities and Exchange Commission on March 14, 2024, together with all other information contained or incorporated by reference in this Quarterly Report on Form 10-Q, when evaluating our business and our prospects. There are no material changes to the risk factors set forth in Part I, Item 1A, in our Annual Report on Form 10-K for the year ended December 31, 2023, except as described below.

 

A significant portion of the funding to further develop our XBB COVID-19 vaccine candidate is currently expected to come from BARDA funds. If BARDA were to eliminate, reduce, delay, or object to funding available to us under the 2024 ASPR-BARDA Contract, this could have a significant, negative impact on our revenues and cash flows, and we may be forced to suspend or terminate the continued development of the product candidate or obtain alternative sources of funding. 

 

In January 2024, we were awarded the 2024 ASPR-BARDA Contract to fund preparation for a Phase 2b clinical study involving 10,000 patients. This study will evaluate our XBB COVID-19 vaccine candidate compared to an approved mRNA vaccine comparator to measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. As of March 31, 2024, we have recognized $1.6 million in revenue pursuant to the 2024 ASPR-BARDA Contract based on the achievement of certain milestones.

 

We anticipate that a significant portion of the funding to further develop our XBB COVID-19 vaccine candidate will come from the remaining amounts to be received under the 2024 ASPR-BARDA Contract. BARDA is entitled to terminate the 2024 ASPR-BARDA Contract for convenience at any time, and is not required to provide continued funding beyond reimbursement of amounts currently incurred and obligated by us as a result of contract performance. If the 2024 ASPR-BARDA Contract is terminated or suspended, or if there is any reduction or delay in funding under the 2024 ASPR-BARDA Contract, our revenues and cash flows would be significantly and negatively impacted and we may be forced to seek alternative sources of funding, which may not be available on non-dilutive terms, terms favorable to us, or at all.

 

Our recurring losses from operations and negative cash flows have raised substantial doubt regarding our ability to continue as a going concern. We will require substantial additional funding to finance our operations, and if we are unable to raise capital, we could be forced to delay, reduce the scope of or eliminate certain of our development programs, or explore other strategic options.

 

Our recurring losses from operations and negative cash flows raise substantial doubt about our ability to continue as a going concern. As of March 31, 2024, we had $36.7 million of cash, cash equivalents and investments. Since March 31, 2024, we raised an additional $0.4 million in gross proceeds net of commissions from the issuance of shares under the Controlled Equity Offering Sales Agreement through the filing date of this Quarterly Report on Form 10-Q. We believe these funds are sufficient to fund our operations into late fourth quarter of 2024. Our ability to continue as a going concern is dependent upon our ability to raise additional capital through outside sources. We plan to raise additional capital through the sale of convertible stock, additional equity, debt financings, government programs, or strategic alliances with third parties. Such financing and funding may not be available at all, or on terms that are favorable to us. Failure to raise additional capital could have a material adverse effect on our business, results of operations, financial condition and/or our ability to fund our scheduled obligations on a timely basis or at all. If we are unable to continue as a going concern, we may be forced to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our consolidated financial statements.

 

 

 

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

 

Item 3.  Defaults Upon Senior Securities

 

Not applicable.

 

 

Item 4.  Mine Safety Disclosures

 

Not applicable.

 

 

 

Item 5.  Other Information

 

During the quarter ended March 31, 2024, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Regulation S-K Item 408.

 

30

 
 

Item 6.  Exhibits

 

 

 

Incorporated by Reference

Exhibit
Number

Description of Document

Schedule/Form

File
Number

Exhibit

Filing Date

           
3.1 Restated Certificate of Incorporation of Aviragen Therapeutics, Inc. Form 10-K 001-35285 3.1 September 13, 2016
           
3.2 Certificate of Amendment to Restated Certificate of Incorporation of Aviragen Therapeutics, Inc. Form 8-K 001-35285 3.1 February 20, 2018
           
3.3 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.2 February 20, 2018
           
3.4 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.1 April 24, 2019
           
3.5 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 8-K 001-35285 3.1 June 9, 2020
           
3.6 Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc. Form 10-Q 001-35285 3.3 August 8, 2022
           
3.7 Amended and Restated Bylaws of Vaxart, Inc., effective as of October 18, 2023 Form 8-K 001-35285 3.1 October 23, 2023
           
10.1 # Letter Agreement, dated January 16, 2024, between Vaxart, Inc. and Michael J. Finney Form 8-K 001-35285 10.1 January 16, 2024
           
10.2 Securities Purchase Agreement, dated January 16, 2024, by and between Vaxart, Inc. and RA Capital Healthcare Fund, L.P. Form 8-K 001-35285 10.1 January 16, 2024
           
10.3 # Separation Agreement, dated January 31, 2024, by and between Vaxart, Inc. and Andrei Floroiu Form 8-K/A 001-35285 10.1 February 2, 2024
           
10.4 # Vaxart, Inc. 2024 Inducement Award Plan Form 8-K 001-35285 10.1 February 29, 2024
           
10.5 # Form of Restricted Stock Unit Award Grant Notice and Award Agreement Form 8-K 001-35285 10.2 February 29, 2024
           
10.6 # Form of Stock Option Grant Notice and Stock Option Agreement Form 8-K 001-35285 10.3 February 29, 2024
           
10.7 # Letter Agreement, dated February 21, 2024, between Vaxart, Inc. and Steven Lo Form 8-K 001-35285 10.1 March 6, 2024

 

10.8 ASPR-BARDA Award/Contract, dated January 12, 2024, between Vaxart, Inc. and the U.S. Government through the Department of Health and Human Services Form 10-K 001-35285 10.59 March 14, 2024

 

 

31.1 *

Certification of Principal Executive Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

       
           
31.2 * Certification of Principal Financial Officer pursuant to Exchange Act Rule, 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002        
           
32.1 § Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002        
           

101.INS *

Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document        
           
101.SCH * Inline XBRL Taxonomy Extension Schema Document        
           
101.CAL * Inline XBRL Taxonomy Extension Calculation Linkbase Document        
           
101.DEF * Inline XBRL Taxonomy Extension Definition Linkbase Document        
           
101.LAB * Inline XBRL Taxonomy Extension Label Linkbase Document        
           
101.PRE * Inline XBRL Taxonomy Extension Presentation Linkbase Document        
           
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)        

 

* Filed herewith.        
           
# Management contract or compensation plan or arrangement.
           

§

In accordance with Item 601(b)(32)(ii) of Regulation S-K and SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, the certification furnished in Exhibit 32.1 hereto is deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.

 


 

 

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, thereunto duly authorized.

 

 

   

VAXART, INC.

 
       
Dated: May 13, 2024   By:  /s/ STEVEN LO  
    Steven Lo

 

    President and Chief Executive Officer  
    (Principal Executive Officer)  
       

Dated: May 13, 2024

 

By:  /s/ PHILLIP LEE

 
   

Phillip Lee

 
   

Chief Financial Officer

 
   

(Principal Financial and Accounting Officer)

 
   

 

 

 

 

33

Exhibit 31.1

 

CERTIFICATION

 

 

I, Steven Lo, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of Vaxart, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

(a)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

(b)

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

(c)

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

(d)

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

(a)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

(b)

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

 

Date: May 13, 2024

 

By:

 /s/ STEVEN LO

 

 

 

Steven Lo
      President and Chief Executive Officer
      (Principal Executive Officer)

 

 

Exhibit 31.2

 

 

 

CERTIFICATION

 

 

I, Phillip Lee, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of Vaxart, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

(a)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

(b)

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

(c)

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

(d)

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

(a)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

(b)

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

 

Date: May 13, 2024

 

By:

 /s/ PHILLIP LEE

 

 

 

Phillip Lee
      Chief Financial Officer
      (Principal Financial and Accounting Officer)

 

 

Exhibit 32.1

 

CERTIFICATION

 

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), Steven Lo, President and Chief Executive Officer of Vaxart, Inc. (the “Company”), and Phillip Lee, Chief Financial Officer of the Company, each hereby certifies that, to his knowledge:

 

 

(1)

The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

 

 

(2)

The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Periodic Report and results of operations of the Company for the period covered by the Periodic Report.

 

 

 

Date: May 13, 2024

 

By:

/s/ STEVEN LO

 

 

 

Steven Lo

      President and Chief Executive Officer
      (Principal Executive Officer)

 

 

 

 

 

Date: May 13, 2024

 

By:

/s/ PHILLIP LEE

 

 

 

Phillip Lee

      Chief Financial Officer
      (Principal Financial and Accounting Officer)

 

 

A signed original of this written statement required by Section 906 of 18 U.S.C. § 1350 has been provided to Vaxart, Inc. and will be retained by Vaxart, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

 

 

 

 

 

 

 

 

 
v3.24.1.1.u2
Document And Entity Information - shares
3 Months Ended
Mar. 31, 2024
May 06, 2024
Document Information [Line Items]    
Entity Central Index Key 0000072444  
Entity Registrant Name Vaxart, Inc.  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2024  
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Mar. 31, 2024  
Document Transition Report false  
Entity File Number 001-35285  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 59-1212264  
Entity Address, Address Line One 170 Harbor Way, Suite 300  
Entity Address, City or Town South San Francisco  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 94080  
City Area Code 650  
Local Phone Number 550-3500  
Title of 12(b) Security Common Stock, $0.0001 par value  
Trading Symbol VXRT  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   176,838,011
v3.24.1.1.u2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 26,735 $ 34,755
Short-term investments 9,929 4,958
Accounts receivable 556 3,008
Prepaid expenses and other current assets 7,064 2,815
Total current assets 44,284 45,536
Property and equipment, net 11,102 11,731
Right-of-use assets, net 23,753 24,840
Intangible assets, net 4,106 4,289
Goodwill 4,508 4,508
Other long-term assets 917 926
Total assets 88,670 91,830
Current liabilities:    
Accounts payable 3,978 1,584
Other accrued current liabilities 4,980 5,634
Current portion of operating lease liability 2,799 2,703
Current portion of liability related to sale of future royalties 2,360 3,803
Total current liabilities 14,117 13,724
Operating lease liability, net of current portion 16,691 17,385
Liability related to sale of future royalties, net of current portion 1,863 2,623
Other long-term liabilities 309 293
Total liabilities 32,980 34,025
Commitments and contingencies (Note 8)
Stockholders’ equity:    
Preferred stock: $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of March 31, 2024 and December 31, 2023 0 0
Common stock: $0.0001 par value; 250,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 177,187,965 shares issued and 176,523,042 shares outstanding as of March 31, 2024 and 153,959,853 shares issued and 153,452,833 shares outstanding as of December 31, 2023 18 15
Additional paid-in capital 490,221 467,731
Treasury stock at cost, 664,923 shares as of March 31, 2024 and 507,020 shares as of December 31, 2023 (548) (366)
Accumulated deficit (433,991) (409,574)
Accumulated other comprehensive loss (10) (1)
Total stockholders’ equity 55,690 57,805
Total liabilities and stockholders’ equity $ 88,670 $ 91,830
v3.24.1.1.u2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares
Mar. 31, 2024
Dec. 31, 2023
Preferred stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Preferred stock, shares authorized (in shares) 5,000,000 5,000,000
Preferred stock, shares issued (in shares) 0 0
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 250,000,000 250,000,000
Common stock, shares issued (in shares) 177,187,965 153,959,853
Common stock, shares outstanding (in shares) 176,523,042 153,452,833
Treasury Stock, Common, Shares (in shares) 664,923 507,020
v3.24.1.1.u2
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Revenues $ 2,181 $ 675
Operating expenses:    
Research and development 19,013 19,622
General and administrative 7,238 6,625
Total operating expenses 26,251 26,247
Operating loss (24,070) (25,572)
Other income (expense):    
Interest income 503 642
Non-cash interest expense related to sale of future royalties (804) (178)
Other expense, net (1) (3)
Loss before income taxes (24,372) (25,111)
Provision for income taxes 45 29
Net loss $ (24,417) $ (25,140)
Net loss per share - basic and diluted (in dollars per share) $ (0.14) $ (0.19)
Shares used to compute net loss per share - basic and diluted (in shares) 168,811,095 135,213,196
Comprehensive loss:    
Net loss $ (24,417) $ (25,140)
Unrealized (loss) gain on available-for-sale investments, net of tax (9) 229
Comprehensive loss (24,426) (24,911)
Non Cash Royalty Revenue [Member]    
Revenues 585 278
Government Contract [Member]    
Revenues 1,596 0
Grant [Member]    
Revenues $ 0 $ 397
v3.24.1.1.u2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
$ in Thousands
September 2021 ATM [Member]
Common Stock [Member]
September 2021 ATM [Member]
Treasury Stock, Common [Member]
September 2021 ATM [Member]
Additional Paid-in Capital [Member]
September 2021 ATM [Member]
Retained Earnings [Member]
September 2021 ATM [Member]
AOCI Attributable to Parent [Member]
September 2021 ATM [Member]
RA Capital Healthcare Fund 2024 [Member]
Common Stock [Member]
RA Capital Healthcare Fund 2024 [Member]
Treasury Stock, Common [Member]
RA Capital Healthcare Fund 2024 [Member]
Additional Paid-in Capital [Member]
RA Capital Healthcare Fund 2024 [Member]
Retained Earnings [Member]
RA Capital Healthcare Fund 2024 [Member]
AOCI Attributable to Parent [Member]
RA Capital Healthcare Fund 2024 [Member]
Common Stock [Member]
Treasury Stock, Common [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
AOCI Attributable to Parent [Member]
Total
Balances (in shares) at Dec. 31, 2022                         134,199,429 0        
Balances at Dec. 31, 2022                         $ 13 $ 0 $ 437,992 $ (327,109) $ (299) $ 110,597
Issuance of common stock (in shares) 1,362,220 0                                
Issuance of common stock $ 1 $ 0 $ 1,429 $ 0 $ 0 $ 1,430                        
Issuance of common stock upon exercise of stock options (in shares)                                   0
Release of common stock for vested restricted stock units (in shares)                         49,220 0        
Release of common stock for vested restricted stock units                         $ 0 $ 0 0 0 0 $ 0
Repurchase of common stock to satisfy tax withholding (in shares)                           (13,553)        
Repurchase of common stock to satisfy tax withholding                           $ (10) 0 0 0 (10)
Stock-based compensation                         0 0 2,647 0 0 2,647
Unrealized loss on available-for-sale investments                         0 0 0 0 229 229
Net loss                         $ 0 $ 0 0 (25,140) 0 (25,140)
Balances (in shares) at Mar. 31, 2023                         135,610,869 (13,553)        
Balances at Mar. 31, 2023                         $ 14 $ (10) 442,068 (352,249) (70) 89,753
Balances (in shares) at Dec. 31, 2023                         153,959,853 (507,020)        
Balances at Dec. 31, 2023                         $ 15 $ (366) 467,731 (409,574) (1) $ 57,805
Issuance of common stock (in shares) 7,404,672 0         15,384,615 0       15,384,615            
Issuance of common stock $ 1 $ 0 $ 8,424 $ 0 $ 0 $ 8,425 $ 2 $ 0 $ 9,943 $ 0 $ 0 $ 9,945            
Issuance of common stock upon exercise of stock options (in shares)                         8,865 0       8,865
Issuance of common stock upon exercise of stock options                         $ 0 $ 0 7 0 0 $ 7
Release of common stock for vested restricted stock units (in shares)                         429,960 0        
Release of common stock for vested restricted stock units                         $ 0 $ 0 0 0 0 0
Repurchase of common stock to satisfy tax withholding (in shares)                           (157,903)        
Repurchase of common stock to satisfy tax withholding                           $ (182) 0 0 0 (182)
Stock-based compensation                         0 0 4,116 0 0 4,116
Unrealized loss on available-for-sale investments                         0 0 0 0 (9) (9)
Net loss                         $ 0 $ 0 0 (24,417) 0 (24,417)
Balances (in shares) at Mar. 31, 2024                         177,187,965 (664,923)        
Balances at Mar. 31, 2024                         $ 18 $ (548) $ 490,221 $ (433,991) $ (10) $ 55,690
v3.24.1.1.u2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Parentheticals) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
September 2021 ATM [Member]    
Offering costs $ 227 $ 103
RA Capital Healthcare Fund 2024 [Member]    
Offering costs $ 55  
v3.24.1.1.u2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Cash flows from operating activities:    
Net loss $ (24,417,000) $ (25,140,000)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 2,177,000 2,062,000
Amortization of discount on investments, net (87,000) (144,000)
Stock-based compensation 4,116,000 2,647,000
Non-cash interest expense related to sale of future royalties 804,000 178,000
Non-cash revenue related to sale of future royalties (3,007,000) (20,000)
Change in operating assets and liabilities:    
Accounts receivable 2,452,000 (244,000)
Prepaid expenses and other assets (4,240,000) 1,067,000
Accounts payable 2,314,000 (270,000)
Deferred grant revenue 0 (397,000)
Other accrued liabilities (1,303,000) (4,199,000)
Net cash used in operating activities (21,191,000) (24,460,000)
Cash flows from investing activities:    
Purchases of property and equipment (131,000) (1,239,000)
Purchases of investments (9,893,000) 0
Proceeds from maturities of investments 5,000,000 26,700,000
Net cash (used in) provided by investing activities (5,024,000) 25,461,000
Cash flows from financing activities:    
Proceeds from issuance of common stock upon exercise of stock options 7,000 0
Shares acquired to settle employee tax withholding liabilities (182,000) (10,000)
Net cash provided by financing activities 18,195,000 1,420,000
Net (decrease) increase in cash, cash equivalents and restricted cash (8,020,000) 2,421,000
Cash, cash equivalents and restricted cash at beginning of the period 34,755,000 46,013,000
Cash, cash equivalents and restricted cash at end of the period 26,735,000 48,434,000
Supplemental reconciliation of cash, cash equivalents and restricted cash in the condensed consolidated balance sheets:    
Cash and cash equivalents 26,735,000 46,831,000
Restricted cash 0 1,603,000
Cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows at the end of the period 26,735,000 48,434,000
Supplemental disclosure of non-cash investing and financing activity:    
Operating lease liabilities arising from obtaining right-of-use assets 0 296,000
Acquisition of property and equipment included in accounts payable and accrued expenses 151,000 246,000
At-the-market Facility [Member]    
Cash flows from financing activities:    
Net proceeds from issuance of common stock 8,425,000 1,430,000
RA Capital Healthcare Fund 2024 [Member]    
Cash flows from financing activities:    
Net proceeds from issuance of common stock $ 9,945,000 $ 0
v3.24.1.1.u2
Note 1 - Organization and Nature of Business
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

NOTE 1.  Organization and Nature of Business

 

General 

 

Vaxart Biosciences, Inc. was originally incorporated in California in March 2004, under the name West Coast Biologicals, Inc. The Company changed its name to Vaxart, Inc. (“Private Vaxart”) in July 2007, and reincorporated in the state of Delaware. In February 2018, Private Vaxart completed a business combination with Aviragen Therapeutics, Inc. (“Aviragen”), pursuant to which Aviragen merged with Private Vaxart, with Private Vaxart surviving as a wholly-owned subsidiary of Aviragen (the “Merger”). Pursuant to the terms of the Merger, Aviragen changed its name to Vaxart, Inc. (together with its subsidiaries, the “Company” or “Vaxart”) and Private Vaxart changed its name to Vaxart Biosciences, Inc.

 

In January 2024, the Company entered into a securities purchase agreement (the “2024 Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-270671) (the “2023 Shelf Registration”). The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

 

On September 15, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “September 2021 ATM”), pursuant to which it may offer and sell, from time to time through sales agents, shares of its common stock having an aggregate offering price of up to $100 million. The Company filed a prospectus supplement with the SEC on September 16, 2021, a subsequent prospectus supplement with the SEC on May 9, 2023 and will pay sales commissions of up to 3.0% of gross proceeds from the sale of shares. In the three months ended March 31, 2024, 7,404,672 shares were issued and sold under the September 2021 ATM for gross proceeds of $8.7 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $8.4 million.

 

The Company’s principal operations are based in South San Francisco, California, and it operates in one reportable segment, which is the discovery and development of oral recombinant protein vaccines, based on its proprietary oral vaccine platform. 

v3.24.1.1.u2
Note 2 - Summary of Significant Accounting Policies
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Significant Accounting Policies [Text Block]

NOTE 2.  Summary of Significant Accounting Policies

 

Basis of Presentation, Liquidity and Going Concern – The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the accounting and disclosure rules and regulations of the SEC assuming the Company will continue as a going concern. 

 

The Company is a clinical-stage biotechnology company with no product sales. Its primary source of capital is from the sale and issuance of common stock and common stock warrants. As of March 31, 2024, the Company had cash, cash equivalents and investments of $36.7 million. The Company’s cash, cash equivalents and investments are not sufficient to fund the Company’s planned operations for a period of 12 months from the date the financial statements are issued. The Company will be dependent upon raising additional capital through placement of its common stock, notes or other securities, borrowings, or entering into a partnership with a strategic party in order to implement its business plan.

 

Based on management's current plan, the Company expects to have enough cash runway into late fourth quarter of 2024. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, management’s plans include further reducing or delaying operating expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

The condensed consolidated balance sheet as of December 31, 2023, included in this filing, was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in consolidated financial statements have been condensed or omitted pursuant to these rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 14, 2024 (the “Annual Report”). Unless noted below, there have been no material changes to the Company’s significant accounting policies described in Note 2 to the consolidated financial statements included in the Annual Report. In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year or any future periods.

 

Basis of Consolidation – The unaudited condensed consolidated financial statements include the financial statements of Vaxart, Inc. and its subsidiaries. All significant transactions and balances between Vaxart, Inc. and its subsidiaries have been eliminated in consolidation.

 

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities in the financial statements and accompanying notes. Actual results and outcomes could differ from these estimates and assumptions.

 

Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents, available-for-sale investments and accounts receivable. The Company places its cash, cash equivalents and available-for-sale investments at financial institutions that management believes are of high credit quality. The Company is exposed to credit risk in the event of default by the financial institutions holding the cash and cash equivalents to the extent such amounts are in excess of the federally insured limits. Losses incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

 

The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer or sector and establishing a minimum allowable credit rating.

 

Recent Accounting Pronouncements

 

The Company has reviewed all significant newly-issued accounting pronouncements that are not yet effective and concluded that they are either not applicable to its operations or their adoption is not expected to have a material impact on its financial position or results of operations.

v3.24.1.1.u2
Note 3 - Fair Value of Financial Instruments
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Fair Value Disclosures [Text Block]

NOTE 3.  Fair Value of Financial Instruments

 

Fair value accounting is applied for all financial assets and liabilities and nonfinancial assets and liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued liabilities that approximate fair value due to their relatively short maturities.

 

Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with inputs used to measure their fair values. The accounting guidance for fair value provides a framework for measuring fair value and requires certain disclosures about how fair value is determined. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance also establishes a three-level valuation hierarchy that prioritizes the inputs to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity.

 

The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:

 

Level 1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;

 

Level 2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and

 

Level 3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.

 

The following table sets forth the fair value of the Company’s financial assets that are measured on a recurring basis as of March 31, 2024 and  December 31, 2023 (in thousands):

 

  

Level 1

  

Level 2

  

Level 3

  

Total

 

March 31, 2024

                

Financial assets:

                

Money market funds

 $17,710  $  $  $17,710 

U.S. Treasury securities

     14,876      14,876 

Total assets

 $17,710  $14,876  $  $32,586 

 

  

Level 1

  

Level 2

  

Level 3

  

Total

 

December 31, 2023

                

Financial assets:

                

Money market funds

 $31,403  $  $  $31,403 

U.S. Treasury securities

     4,958      4,958 

Total assets

 $31,403  $4,958  $  $36,361 

 

The Company held no financial liabilities measured on a recurring basis as of  March 31, 2024 or December 31, 2023.

 

 

v3.24.1.1.u2
Note 4 - Balance Sheet Components
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Supplemental Balance Sheet Disclosures [Text Block]

NOTE 4.  Balance Sheet Components

 

 

(a)

Cash, Cash Equivalents and Investments

 

Cash, cash equivalents and investments consisted of the following (in thousands):

 

  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

Cash Equivalents

  

Investments

 

March 31, 2024

                        

Cash at banks

 $4,078  $  $  $4,078  $4,078  $ 

Money market funds

  17,710         17,710   17,710    

U.S. Treasury securities

  14,886      (10)  14,876   4,947   9,929 

Total

 $36,674  $  $(10) $36,664  $26,735  $9,929 

 

  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and 

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

Cash Equivalents

  

Investments

 

December 31, 2023

                        

Cash at banks

 $3,352  $  $  $3,352  $3,352    

Money market funds

  31,403         31,403   31,403    

U.S. Treasury securities

  4,959      (1)  4,958      4,958 

Total

 $39,714  $  $(1) $39,713  $34,755  $4,958 

  

As of March 31,2024 and December 31, 2023, all investments were available-for-sale debt securities with remaining maturities of 12 months or less.

 

 

(b)

Accounts Receivable

 

Accounts receivable comprises royalties receivable of $0.6 million and $3.0 million as of March 31, 2024 and December 31, 2023, respectively. The Company has provided no allowance for credit losses as of March 31, 2024 and December 31, 2023, based on past events and subsequent receipts.

 

 

(c)

Prepaid Expenses and Other Current Assets

 

Prepaid expenses and other current assets consists of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Prepaid clinical and manufacturing expenses

 $1,762  $984 

Unbilled revenue from government contracts

  

1,596

    
Prepaid insurance  933   258 
Prepaid rent  528   488 
Interest receivable  140   127 
Other  2,105   958 

Prepaid expenses and other current assets

 $7,064  $2,815 

 

 

(d)

Property and Equipment, Net

 

Property and equipment, net consists of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Laboratory equipment

 $13,507  $13,448 

Office and computer equipment

  1,105   1,105 

Leasehold improvements

  3,998   3,985 

Construction in progress

  226   24 

Total property and equipment

  18,836   18,562 

Less: accumulated depreciation

  (7,734)  (6,831)

Property and equipment, net

 $11,102  $11,731 

 

Depreciation expense was $0.9 million for the three months ended March 31, 2024 and 2023. There were no impairments of the Company’s property and equipment recorded in the three months ended March 31, 2024 or 2023.

 

 

(e)

Right-of-Use Assets, Net

 

Right-of-use assets, net comprises facilities of $23.8 million and $24.8 million as of March 31, 2024 and December 31, 2023, respectively. The right-of-use of additional leased premises in California commenced in 2023, resulting in an additional $3.1 million right-of-use assets recorded in the year ended December 31, 2023.

 

 

(f)

Intangible Assets, Net

 

Intangible assets comprise developed technology and intellectual property. Intangible assets are carried at cost less accumulated amortization. As of March 31, 2024, developed technology and intellectual property had remaining lives of 5.6 and 3.75 years, respectively. As of March 31, 2024, there have been no indicators of impairment. Intangible assets consist of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Developed technology

 $5,000  $5,000 

Intellectual property

  80   80 

Total cost

  5,080   5,080 

Less: accumulated amortization

  (974)  (791)

Intangible assets, net

 $4,106  $4,289 

  

Intangible asset amortization expense was $0.2 million for the three months ended March 31, 2024 and 2023.

 

As of March 31, 2024, the estimated future amortization expense by year is as follows (in thousands):

 

Year Ending December 31,

 

Amount

 

2024 (nine months remaining)

 $548 

2025

  732 

2026

  731 

2027

  731 

2028

  727 

Thereafter

  637 

Total

 $4,106 

 

 

(g)

Goodwill

 

Goodwill, which represents the excess of the purchase price over the fair value of assets acquired, comprises $4.5 million as of March 31, 2024 and December 31, 2023. As of March 31, 2024, there have been no indicators of impairment.

 

 

(h)

Other Accrued Current Liabilities

 

Other accrued current liabilities consist of the following (in thousands):

 

  

March 31, 2024

  

December 31, 2023

 
         

Accrued compensation

 $3,199  $4,576 

Accrued clinical and manufacturing expenses

  180   312 

Accrued professional and consulting services

  707   211 

Other liabilities, current portion

  894   535 

Total

 $4,980  $5,634

 

 

v3.24.1.1.u2
Note 5 - Revenue
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Revenue [Text Block]

NOTE 5.  Revenue

 

Royalty Revenue Related to Sale of Future Royalties

 

The Company generates royalty revenue from the sale of Inavir in Japan, pursuant to a collaboration and license agreement that Aviragen entered into with Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) in 2009. In September 2010, laninamivir octanoate was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children, which Daiichi Sankyo markets as Inavir. Under the agreement, the Company currently receives a 4% royalty on net sales of Inavir in Japan. Based on information provided by Daiichi Sankyo, the Company believes the expiration of the last patent related to Inavir is in  August 2036, at which time royalty revenue will cease. The Company’s royalty revenue is seasonal, in line with the flu season, so the majority of the Company’s royalty revenue and non-cash royalty revenue related to the sale of future royalties are earned in the first and fourth fiscal quarters. The royalty revenue related to Inavir recognized for the three months ended March 31, 2024 and 2023, was zero. The Company recognized non-cash royalty revenue related to sale of future royalties of $0.6 million and $0.3 million for the three months ended March 31, 2024 and 2023, respectively (see Note 6). Both royalty revenue and the non-cash royalty revenue related to the sale of future royalties are subject to a 5% withholding tax in Japan, for which $29,000 and $14,000 was included in income tax expense for the three months ended March 31, 2024 and 2023, respectively.

 

Revenue from Government Contracts

 

On January 12, 2024, the Company was awarded a contract (the “2024 ASPR-BARDA Contract”) by the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Administration for Strategic Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, the Company received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare the Company’s XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. The Company accounts for the 2024 ASPR-BARDA Contract under Accounting Standards Codification 958-605 and recognizes revenue as donor-imposed conditions are met. The Company recognized revenue from government contracts of $1.6 million for the three months ended March 31, 2024, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract. Unbilled revenue from government contracts was $1.6 million as of March 31, 2024.

 

Grant Revenue

 

In  November 2022, the Company accepted a $3.5 million grant to perform research and development work for the Bill & Melinda Gates Foundation (the “BMGF Grant”) and received $2.0 million in advance that was recorded as restricted cash and deferred revenue. The Company received an additional $1.5 million in  July 2023 upon completion of certain milestones. The Company recognizes revenue under research contracts only when a contract is executed and the contract price is fixed or determinable. Revenue from the BMGF Grant was recognized in the period during which the related costs were incurred and the related services rendered, as the applicable conditions under the contract were met. Costs of contract revenue were recorded as a component of operating expenses in the consolidated statements of operations and comprehensive loss. The Company recognized revenue from the BMGF Grant of zero and $0.4 million for the three months ended March 31, 2024 and 2023, respectively. The Company fully recognized revenue from the BMGF Grant during the year ended December 31, 2023.

 

 

v3.24.1.1.u2
Note 6 - Liabilities Related to Sale of Future Royalties
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Liabilities Related to Sale of Future Royalties [Text Block]

NOTE 6.  Liabilities Related to Sale of Future Royalties

 

In April 2016, Aviragen entered into a Royalty Interest Acquisition Agreement (the “RIAA”) with HealthCare Royalty Partners III, L.P. (“HCRP”). Under the RIAA, HCRP made a $20.0 million cash payment to Aviragen in consideration for acquiring certain royalty rights (“Royalty Rights”) related to the approved product Inavir in the Japanese market. The Royalty Rights were obtained pursuant to the collaboration and license agreements (the “License Agreement”) and a commercialization agreement that the Company entered into with Daiichi Sankyo. Per the terms of the RIAA, during the first royalty interest period of April 1, 2016 through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by the Company. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount, plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by the Company. A shortfall occurs when, during an annual period ending on  March 31st, for the first royalty interest period of April 1, 2016 through March 31, 2025, the Company’s royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there shall remain any cumulative remaining shortfall amount as of December 24, 2029, any royalties received from Daiichi Sankyo subsequently by the Company would be payable to HCRP until the cumulative remaining shortfall amount has been paid.

 

For avoidance of doubt, the RIAA states, in the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, the Company shall not be obligated to pay HCRP any royalty payment beyond what the Company is paid from Daiichi Sankyo. The cumulative remaining shortfall amount is the aggregate amount of the remaining shortfall for each annual period, which was $6.0 million and $7.0 million as of March 31, 2024 and December 31, 2023, respectively.

 

Under the relevant accounting guidance, due to a limit on the amount of royalties that HCRP can earn under the RIAA, this transaction was accounted for as a liability that is being amortized using the effective interest method over the life of the arrangement. The Company has no obligation to pay any amounts to HCRP other than to pass through to HCRP its share of royalties as they are received from Daiichi Sankyo. To record the amortization of the liability, the Company is required to estimate the total amount of future royalty payments to be received under the License Agreement and the payments that will be passed through to HCRP over the life of this agreement. Consequently, the Company imputes interest on the unamortized portion of the liability and records non-cash interest expense using an estimated effective interest rate. The royalties earned in each period that will be passed through to HCRP are recorded as non-cash royalty revenue related to sale of future royalties, with any excess not subject to pass-through being recorded as royalty revenue. When the pass-through royalties are paid to HCRP in the following quarter, the imputed liability related to sale of future royalties is commensurately reduced. The Company periodically assesses the expected royalty payments, and to the extent such payments are greater or less than the initial estimate, the Company adjusts the amortization of the liability and interest rate. As a result of this accounting, even though the Company does not retain HCRP’s share of the royalties, it will continue to record non-cash revenue related to those royalties until the amount of the associated liability, including the related interest, is fully amortized.

 

The following table shows the activity within the liability account during the three months ended March 31, 2024 (in thousands):

 

Total liability related to sale of future royalties, start of period

 $6,426 

Non-cash royalty revenue paid to HCRP

  (3,007)

Non-cash interest expense recognized

  804 

Total liability related to sale of future royalties, end of period

  4,223 

Current portion

  (2,360)

Long-term portion

 $1,863 

 

v3.24.1.1.u2
Note 7 - Leases
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Lessee, Operating Leases [Text Block]

NOTE 7.  Leases

 

The Company has obtained the right of use for office and manufacturing facilities under six operating lease agreements with initial terms exceeding one year. The lease term at the commencement date is determined by considering whether renewal options and termination options are reasonably assured of exercise.

 

In  September 2021, the Company executed a lease for a facility in South San Francisco, California, with an initial term expiring on  March 31, 2029. This lease has two separate components, one commenced in the third quarter of 2022 and the other in the first quarter of 2023, resulting in an additional right of use asset $15.0 million and $3.1 million, respectively.

 

As of March 31, 2024, the weighted average discount rate for operating leases with initial terms of more than one year was 9.8% and the weighted average remaining term of these leases was 4.9 years. Discount rates were determined using the Company’s marginal rate of borrowing at the time each lease was executed or extended.

 

The following table summarizes the Company’s undiscounted cash payment obligations for its operating lease liabilities with initial terms of more than 12 months as of  March 31, 2024 (in thousands):

 

Year Ending December 31,

    

2024 (nine months remaining)

 $3,306 

2025

  4,511 

2026

  5,031 

2027

  5,207 

2028

  5,389 

Thereafter

  1,348 

Undiscounted total

  24,792 

Less: imputed interest

  (5,302)

Present value of future minimum payments

  19,490 

Current portion of operating lease liability

  (2,799)

Operating lease liability, net of current portion

 $16,691 

 

The Company is also required to pay for operating expenses related to the leased space. The operating expenses are incurred separately and were not included in the present value of lease payments. Operating lease expenses for the three months ended March 31, 2024 and 2023, are summarized as follows (in thousands):

 

  

Three Months Ended March 31,

 
  

2024

  

2023

 

Lease cost

        

Operating lease cost

 $1,554  $1,510 

Short-term lease cost

  12   21 

Variable lease cost

  504   511 

Sublease income

  (14)   

Total lease cost

 $2,056  $2,042 

 

v3.24.1.1.u2
Note 8 - Commitments and Contingencies
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Commitments and Contingencies Disclosure [Text Block]

NOTE 8.  Commitments and Contingencies

 

 

(a)

Purchase Commitments

 

As of March 31, 2024, the Company had approximately $3.6 million of non-cancelable purchase commitments, principally for contract manufacturing and clinical services which are expected to be paid within the next year. In addition, the Company has operating lease commitments as detailed in Note 7.

 

 

(b)

Indemnifications

 

In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has also entered into indemnification agreements with certain officers and directors which provide, among other things, that the Company will indemnify and advance expenses incurred in connection with certain actions, suits or proceedings to such officer or director, under the circumstances and to the extent provided for therein, for expenses, damages, judgments, fines and settlements he or she may be required to pay in actions or proceedings which he or she is or may be made a party by reason of his or her position as a director, officer or other agent of the Company, and otherwise to the fullest extent permitted under Delaware law and the Company’s Bylaws. The Company currently has directors’ and officers’ insurance.

 

 

(c)

Litigation

 

From time to time the Company may be involved in legal proceedings arising in connection with its business. Based on information currently available, the Company believes that the amount, or range, of reasonably possible losses in connection with any pending actions against it in excess of established reserves, in the aggregate, is indeterminable to its consolidated financial condition or cash flows. However, any current or future dispute resolution or legal proceeding, regardless of the merits of any such proceeding, could result in substantial costs and a diversion of management’s attention and resources that are needed to run the Company successfully, and could have a material adverse impact on its business, financial condition and results of operations.

 

In August and September 2020, two substantially similar securities class actions were filed in the U.S. District Court for the Northern District of California. The first action, titled Himmelberg v. Vaxart, Inc. et al. was filed on August 24, 2020. The second action, titled Hovhannisyan v. Vaxart, Inc. et al. was filed on September 1, 2020 (together, the “Putative Class Action”). By Order dated September 17, 2020, the two actions were deemed related. On December 9, 2020, the court appointed lead plaintiffs and lead plaintiffs’ counsel.

 

On January 29, 2021, lead plaintiffs filed their consolidated amended complaint. On July 8, 2021, all defendants moved to dismiss the consolidated amended complaint. On May 14, 2021, the court granted lead plaintiffs’ request to amend the consolidated amended complaint and denied defendants’ motions to dismiss as moot. On June 10, 2021, lead plaintiffs filed a first amended consolidated complaint, and on August 9, 2021, lead plaintiffs filed a corrected first amended consolidated complaint. The first amended consolidated complaint, as corrected, named certain of Vaxart’s current and former executive officers and directors, as well as Armistice Capital, LLC (“Armistice”), as defendants. It claimed three violations of federal civil securities laws; violation of Section 10(b) of the Exchange Act and SEC Rule 10b-5, as against the Company and all individual defendants; violation of Section 20(a) of the Exchange Act, as against Armistice and all individual defendants; and violation of Section 20A of the Exchange Act against Armistice. The first amended consolidated complaint, as corrected, alleged that the defendants violated securities laws by misstating and/or omitting information regarding the Company’s development of a norovirus vaccine, the vaccine manufacturing capabilities of a business counterparty, and the Company’s involvement with Operation Warp Speed (“OWS”); and by engaging in a scheme to inflate Vaxart’s stock price. The first amended consolidated complaint sought certification as a class action for similarly situated shareholders and sought, among other things, an unspecified amount of damages and attorneys’ fees and costs. On July 8, 2021, all defendants moved to dismiss the first amended consolidated complaint. By Order dated December 22, 2021, the court granted the motion to dismiss by Armistice with leave to amend and otherwise denied the motions to dismiss. On July 27, 2022, lead plaintiffs filed a notice announcing that they had reached a partial settlement (the “Partial Settlement”) to resolve all claims against the Company and its current or former officers and/or directors in their capacity as officers and/or directors of the Company (the “Settling Defendants”). Pursuant to the Partial Settlement, the Company agreed to a settlement amount of $12.0 million with $2.0 million to be paid by the Company and the remainder to be paid by the Company’s insurers. On November 2, 2022, the Company paid the $2.0 million settlement amount with respect to the Putative Class Action pursuant to the terms of the settlement agreement reached in that case. On November 14, 2022, lead plaintiffs filed a second amended consolidated class action complaint that purported to include new allegations to support claims against Armistice. By Orders dated January 25, 2023, the court approved the Partial Settlement and entered judgment dismissing with prejudice all claims asserted in the Putative Class Action against the Settling Defendants.

 

On October 23, 2020, a complaint was filed in the U.S. District Court for the Southern District of New York, entitled Roth v. Armistice Capital LLC, et al. The complaint names Armistice and certain Armistice-related parties as defendants, asserting a violation of Exchange Act Section 16(b) and seeking the disgorgement of short-swing profits. The complaint purports to bring the lawsuit on behalf of and for the benefit of the Company and names the Company as a “nominal defendant” for whose benefit damages are sought. Following discovery, a motion for summary judgment was filed by Armistice and the Armistice-related party defendants to dismiss the complaint. On March 27, 2024, the court granted the motion for summary judgment and dismissed all claims in the complaint in their entirety. On April 11, 2024, the Plaintiff timely filed a notice of appeal of the court’s decision to the Second Circuit Court of Appeals, commencing appellate proceedings.

 

On January 8, 2021, a purported shareholder, Phillip Chan, commenced a pro se lawsuit in the U.S. District Court for the Northern District of California titled Chan v. Vaxart, Inc. et al. (the “Opt-Out Action”), opting out of the consolidated Himmelberg v. Vaxart, Inc. et al. and Hovhannisyan v. Vaxart, Inc. et al. class actions, (together, the “Putative Class Action”). Because this complaint is nearly identical to an earlier version of a complaint filed in the Putative Class Action, the Opt-Out Action has been stayed while the Putative Class Action is pending.

 

v3.24.1.1.u2
Note 9 - Stockholders' Equity
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Equity [Text Block]

NOTE 9.  Stockholders’ Equity

 

 

(a)

Preferred Stock

 

The Company is authorized to issue 5,000,000 shares of preferred stock, $0.0001 par value per share. The Company’s board of directors may, without further action by the stockholders, fix the rights, preferences, privileges and restrictions of up to an aggregate of 5,000,000 shares of preferred stock in one or more series and authorize their issuance. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of our common stock. The issuance of preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation. In addition, the issuance of preferred stock could have the effect of delaying, deterring or preventing a change of control or other corporate action. No shares of preferred stock are currently outstanding, and the Company has no present plan to issue any shares of preferred stock.

 

 

(b)

Common Stock

 

As of March 31, 2024, the Company was authorized to issue 250,000,000 shares of common stock, $0.0001 par value per share, which includes an increase of 100,000,000 on August 4, 2022, when the Company’s stockholders approved an amendment to the Company’s certificate of incorporation to increase the number of authorized shares of common stock from 150,000,000 shares. Except as otherwise required by law or as otherwise provided in any certificate of designation for any series of preferred stock, the holders of common stock possess all voting power for the election of the Company’s directors and all other matters requiring stockholder action. Holders of common stock are entitled to one vote per share on matters to be voted on by stockholders. Holders of common stock are entitled to receive such dividends, if any, as may be declared from time to time by the Company’s board of directors at its discretion out of funds legally available therefor. In no event will any stock dividends or stock splits or combinations of stock be declared or made on common stock unless the shares of common stock at the time outstanding are treated equally and identically. As of March 31, 2024, no dividends had been declared by the board of directors.

 

In January 2024, the Company entered into the 2024 Securities Purchase Agreement with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the Company’s 2023 Shelf Registration. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.

 

In the event of the Company’s voluntary or involuntary liquidation, dissolution, distribution of assets or winding-up, the holders of the common stock will be entitled to receive an equal amount per share of all the Company’s assets of whatever kind available for distribution to stockholders, after the rights of the holders of the preferred stock have been satisfied. There are no sinking fund provisions applicable to the common stock.

 

The Company had shares of common stock reserved for issuance as follows:

 

  

March 31, 2024

  

December 31, 2023

 
         

Options issued and outstanding

  21,843,566   17,938,726 

RSUs issued and outstanding

  3,313,997   2,126,373 

2019 Equity Incentive Plan available for future grant

  1,404,517   5,685,806 

2024 Inducement Award Plan available for future grant

  1,750,000    

Common stock warrants

  211,259   227,434 

2022 Employee Stock Purchase Plan available for issuance

  1,065,325   1,065,325 

Total

  29,588,664   27,043,664 

 

 

(c)

Warrants

 

The following warrants were outstanding as of March 31, 2024, all of which contain standard anti-dilution protections in the event of subsequent rights offerings, stock splits, stock dividends or other extraordinary dividends, or other similar changes in the Company’s common stock or capital structure, and none of which have any participating rights for any losses:

 

Securities into which warrants are convertible

 

Warrants Outstanding

  

Exercise Price

 

Expiration Date

          

Common Stock

  44,148  $1.10 

April 2024

Common Stock

  26,515  $1.375 

April 2024

Common Stock

  29,150  $2.50 

March 2025

Common Stock

  100,532  $3.125 

February 2025

Common Stock

  10,914  $22.99 

December 2026

Total

  211,259      

 

In April 2024, 70,663 of the warrants outstanding as of March 31, 2024, expired unexercised. In the event of a Fundamental Transaction (a transfer of ownership of the Company as defined in the warrant) within the Company’s control, the holders of the unexercised common stock warrants exercisable for $1.10 and $2.50 and those exercisable for $3.125 expiring in February 2025 shall be entitled to receive cash consideration equal to a Black-Scholes valuation, as defined in the warrant. If such Fundamental Transaction is not within the Company’s control, the warrant holders would only be entitled to receive the same form of consideration (and in the same proportion) as the holders of the Company’s common stock, hence these warrants are classified as a component of permanent equity.

 

v3.24.1.1.u2
Note 10 - Equity Incentive Plans
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Share-Based Payment Arrangement [Text Block]

NOTE 10.  Equity Incentive Plans

 

On April 23, 2019, the Company’s stockholders approved the adoption of the 2019 Equity Incentive Plan (the “2019 Plan”), under which the Company is authorized to issue incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), other stock awards and performance awards that may be settled in cash, stock, or other property. The 2019 Plan is designed to secure and retain the services of employees, directors and consultants, provide incentives for the Company’s employees, directors and consultants to exert maximum efforts for the success of the Company and its affiliates, and provide a means by which employees, directors and consultants may be given an opportunity to benefit from increases in the value of the Company’s common stock. Following adoption of the 2019 Plan, all previous plans were frozen, and on forfeiture, cancellation and expiration, awards under those plans are not assumed by the 2019 Plan.

 

The aggregate number of shares of common stock authorized for issuance under the 2019 Plan was initially 1,600,000 shares, which was increased through an amendment to the 2019 Plan adopted by the Company’s stockholders (a “Plan Amendment”) on June 8, 2020, to 8,000,000, by a Plan Amendment on June 16, 2021, to 16,900,000, and by a Plan Amendment on August 4, 2022, to 28,900,000. Further amendments to the 2019 Plan to increase the share reserve would require stockholder approval. Awards that are forfeited or canceled generally become available for issuance again under the 2019 Plan. Awards have a maximum term of ten years from the grant date and may vest over varying periods, as specified by the Company’s board of directors for each grant.

 

On February 27, 2024, the Company's board of directors adopted the Vaxart, Inc. 2024 Inducement Award Plan (the “2024 Inducement Plan”). The 2024 Inducement Plan was adopted without stockholder approval pursuant to Nasdaq Listing Rule 5635(c)(4) and is administered by the Compensation Committee of the board of directors or the independent members of the board of directors. The board of directors reserved 3,000,000 shares of the Company’s common stock for issuance under the 2024 Inducement Plan, subject to adjustment as provided in the plan document. The terms of the 2024 Inducement Plan are substantially similar to the terms of the 2019 Plan, with the exception that incentive stock options may not be issued under the 2024 Inducement Plan and equity awards under the 2024 Inducement Plan (including nonqualified stock options, restricted stock, restricted stock units, and other stock-based awards) may be issued only to an employee who is commencing employment with the Company or any subsidiary or who is being rehired following a bona fide interruption of employment by the Company or any subsidiary, in either case if he or she is granted such award in connection with his or her commencement of employment and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary.

 

A summary of stock option and RSU transactions in the three months ended March 31, 2024, is as follows:

 

          

Weighted

      

Weighted

 
  

Shares

  

Number of

  

Option Average

  

Unvested

  

RSU Average

 
  

Available

  

Options

  

Exercise

  

RSU Shares

  

Grant Date

 
  

For Grant

  

Outstanding

  

Price

  

Outstanding

  

Fair Value

 
                     

Balance as of January 1, 2024

  5,685,806   17,938,726  $2.90   2,126,373  $1.37 

Authorized under 2024 Inducement Plan

  

3,000,000

                 

Granted

  (6,555,730)  

4,734,937

  $1.16   1,820,793  $1.16 

Exercised

      (8,865) $0.78         

Released

              (429,960) $1.27 

Forfeited

 

 

981,822

   (778,613) $2.40   (203,209) $1.75 

Canceled

  42,619   (42,619) $3.35         
                     

Balance as of March 31, 2024

  3,154,517   21,843,566  $2.54   3,313,997  $1.24 

 

As of March 31, 2024, there were 21,843,566 options outstanding with a weighted average exercise price of $2.54, a weighted average remaining term of 7.58 years and an aggregate intrinsic value of $4.4 million. Of these options, 11,444,731 were vested, with a weighted average exercise price of $3.02, a weighted average remaining term of 6.15 years and an aggregate intrinsic value of $2.2 million. 

 

The Company received $7,000 for the 8,865 options exercised during the three months ended March 31, 2024, which had an intrinsic value of $3,000. There were no options exercised during the three months ended March 31, 2023. The aggregate intrinsic value represents the total pre-tax value (i.e., the difference between the Company’s stock price and the exercise price) of stock options outstanding as of March 31, 2024, based on the Company’s common stock closing price of $1.30 on March 28, 2024, the prior business day, which would have been received by the option holders had all their in-the-money options been exercised as of that date.

 

The weighted average grant date fair value of options awarded in the three months ended March 31, 2024 and 2023, was $1.04 and $0.78, respectively. Their fair values were estimated using the following assumptions:

 

  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Risk-free interest rate

  4.4%  3.5% - 3.6%

Expected term (in years)

  6.00   6.00 

Expected volatility

  129.1%  128.0%

Dividend yield

  %  %

 

The Company measures the fair value of all stock-based awards on the grant date and records the fair value of these awards, net of estimated forfeitures, to compensation expense over the service period. Total stock-based compensation recognized for options, RSUs and ESPP was as follows (in thousands):

 

  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Research and development

 $1,807  $1,372 

General and administrative

  2,309   1,275 

Total stock-based compensation

 $4,116  $2,647 

 

As of March 31, 2024, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $21.9 million, which the Company expects to recognize over an estimated weighted average period of 2.59 years.

 

On August 4, 2022, the 2022 Employee Stock Purchase Plan (the “2022 ESPP”) was approved by the Company’s stockholders. The Company reserved 1,800,000 shares of the Company’s common stock for purchase under the 2022 ESPP. The 2022 ESPP has a six-month offering period comprised of one purchase period. The purchase price of the stock is equal to 85% of the lesser of the market value of such shares at the beginning of the six-month offering period or the end of such offering period. During the three months ended March 31, 2024, the Company did not issue any shares under the 2022 ESPP. As of March 31, 2024, 1,065,325 shares are available and reserved for future issuance under the 2022 ESPP.

 

The estimated fair value used for the six-month offering period beginning December 1, 2023 and ending May 31, 2024, was $0.27 per share. The estimated fair value used for the six-month offering period beginning December 1, 2022 and ending May 31, 2023, was $0.46 per share. As of March 31, 2024, the unrecognized stock-based compensation cost related to the outstanding 2022 ESPP offering period expected to be recognized by May 31, 2024, is $42,000. The fair value of the 2022 ESPP shares was estimated using the Black-Scholes option pricing model using the following assumptions:

 

  

Six-Month Offering Period Ending May 31, 2024

  

Six-Month Offering Period Ended May 31, 2023

 
         

Risk-free interest rate

  5.3%  4.6%

Expected term (in years)

  0.50   0.50 

Expected volatility

  75.2%  84.7%

Dividend yield

  %  %

 

v3.24.1.1.u2
Note 11 - Net Loss Per Share Attributable to Common Stockholders
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Earnings Per Share [Text Block]

NOTE 11.  Net Loss Per Share Attributable to Common Stockholders

 

The following table presents the calculation of basic and diluted net loss per share (in thousands, except share and per share amounts):

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Net loss

  $ (24,417 )   $ (25,140 )
                 

Shares used to compute net loss per share – basic and diluted

    168,811,095       135,213,196  
                 

Net loss per share – basic and diluted

  $ (0.14 )   $ (0.19 )

 

No adjustment has been made to the net loss in the three months ended March 31, 2024 and 2023, as the effect would be anti-dilutive due to the net loss.

 

The following potentially dilutive weighted average securities were excluded from the computation of weighted average shares outstanding because they would have been antidilutive:

 

   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Options to purchase common stock

    18,034,438       14,436,046  
                 

Restricted stock units to purchase common stock

    1,977,053       1,218,200  
                 

Warrants to purchase common stock

    211,259       227,434  
                 

Employee Stock Purchase Plan

    471,638       433,328  
                 

Total potentially dilutive securities excluded from denominator of the diluted earnings per share computation

    20,694,388       16,315,008  
v3.24.1.1.u2
Note 12 - Subsequent Events
3 Months Ended
Mar. 31, 2024
Notes to Financial Statements  
Subsequent Events [Text Block]

 

Note 12. Subsequent Events

 

Since March 31, 2024, the Company has issued 314,969 shares of common stock under the September 2021 ATM (see Note 1) for gross proceeds net of commissions totaling $0.4 million through the filing date of this Quarterly Report on Form 10-Q.

 

v3.24.1.1.u2
Insider Trading Arrangements
3 Months Ended
Mar. 31, 2024
Insider Trading Arr Line Items  
Material Terms of Trading Arrangement [Text Block]

Item 5.  Other Information

 

During the quarter ended March 31, 2024, no director or officer, as defined in Rule 16a-1(f), adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” each as defined in Regulation S-K Item 408.

 

Rule 10b5-1 Arrangement Adopted [Flag] false
Rule 10b5-1 Arrangement Terminated [Flag] false
Non-Rule 10b5-1 Arrangement Adopted [Flag] false
Non-Rule 10b5-1 Arrangement Terminated [Flag] false
v3.24.1.1.u2
Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2024
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]

Basis of Presentation, Liquidity and Going Concern – The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the accounting and disclosure rules and regulations of the SEC assuming the Company will continue as a going concern. 

 

The Company is a clinical-stage biotechnology company with no product sales. Its primary source of capital is from the sale and issuance of common stock and common stock warrants. As of March 31, 2024, the Company had cash, cash equivalents and investments of $36.7 million. The Company’s cash, cash equivalents and investments are not sufficient to fund the Company’s planned operations for a period of 12 months from the date the financial statements are issued. The Company will be dependent upon raising additional capital through placement of its common stock, notes or other securities, borrowings, or entering into a partnership with a strategic party in order to implement its business plan.

 

Based on management's current plan, the Company expects to have enough cash runway into late fourth quarter of 2024. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, management’s plans include further reducing or delaying operating expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.

 

The condensed consolidated balance sheet as of December 31, 2023, included in this filing, was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in consolidated financial statements have been condensed or omitted pursuant to these rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 14, 2024 (the “Annual Report”). Unless noted below, there have been no material changes to the Company’s significant accounting policies described in Note 2 to the consolidated financial statements included in the Annual Report. In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year or any future periods.

 

Consolidation, Policy [Policy Text Block]

Basis of Consolidation – The unaudited condensed consolidated financial statements include the financial statements of Vaxart, Inc. and its subsidiaries. All significant transactions and balances between Vaxart, Inc. and its subsidiaries have been eliminated in consolidation.

 

Use of Estimates, Policy [Policy Text Block]

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities in the financial statements and accompanying notes. Actual results and outcomes could differ from these estimates and assumptions.

 

Concentration Risk, Credit Risk, Policy [Policy Text Block]

Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents, available-for-sale investments and accounts receivable. The Company places its cash, cash equivalents and available-for-sale investments at financial institutions that management believes are of high credit quality. The Company is exposed to credit risk in the event of default by the financial institutions holding the cash and cash equivalents to the extent such amounts are in excess of the federally insured limits. Losses incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.

 

The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in any one corporate issuer or sector and establishing a minimum allowable credit rating.

 

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements

 

The Company has reviewed all significant newly-issued accounting pronouncements that are not yet effective and concluded that they are either not applicable to its operations or their adoption is not expected to have a material impact on its financial position or results of operations.

v3.24.1.1.u2
Note 3 - Fair Value of Financial Instruments (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Fair Value, Assets Measured on Recurring Basis [Table Text Block]
  

Level 1

  

Level 2

  

Level 3

  

Total

 

March 31, 2024

                

Financial assets:

                

Money market funds

 $17,710  $  $  $17,710 

U.S. Treasury securities

     14,876      14,876 

Total assets

 $17,710  $14,876  $  $32,586 
  

Level 1

  

Level 2

  

Level 3

  

Total

 

December 31, 2023

                

Financial assets:

                

Money market funds

 $31,403  $  $  $31,403 

U.S. Treasury securities

     4,958      4,958 

Total assets

 $31,403  $4,958  $  $36,361 
v3.24.1.1.u2
Note 4 - Balance Sheet Components (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Cash, Cash Equivalents and Investments [Table Text Block]
  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

Cash Equivalents

  

Investments

 

March 31, 2024

                        

Cash at banks

 $4,078  $  $  $4,078  $4,078  $ 

Money market funds

  17,710         17,710   17,710    

U.S. Treasury securities

  14,886      (10)  14,876   4,947   9,929 

Total

 $36,674  $  $(10) $36,664  $26,735  $9,929 
  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and 

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

Cash Equivalents

  

Investments

 

December 31, 2023

                        

Cash at banks

 $3,352  $  $  $3,352  $3,352    

Money market funds

  31,403         31,403   31,403    

U.S. Treasury securities

  4,959      (1)  4,958      4,958 

Total

 $39,714  $  $(1) $39,713  $34,755  $4,958 
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block]
  

March 31, 2024

  

December 31, 2023

 
         

Prepaid clinical and manufacturing expenses

 $1,762  $984 

Unbilled revenue from government contracts

  

1,596

    
Prepaid insurance  933   258 
Prepaid rent  528   488 
Interest receivable  140   127 
Other  2,105   958 

Prepaid expenses and other current assets

 $7,064  $2,815 
Property, Plant and Equipment [Table Text Block]
  

March 31, 2024

  

December 31, 2023

 
         

Laboratory equipment

 $13,507  $13,448 

Office and computer equipment

  1,105   1,105 

Leasehold improvements

  3,998   3,985 

Construction in progress

  226   24 

Total property and equipment

  18,836   18,562 

Less: accumulated depreciation

  (7,734)  (6,831)

Property and equipment, net

 $11,102  $11,731 
Schedule of Finite-Lived Intangible Assets [Table Text Block]
  

March 31, 2024

  

December 31, 2023

 
         

Developed technology

 $5,000  $5,000 

Intellectual property

  80   80 

Total cost

  5,080   5,080 

Less: accumulated amortization

  (974)  (791)

Intangible assets, net

 $4,106  $4,289 
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block]

Year Ending December 31,

 

Amount

 

2024 (nine months remaining)

 $548 

2025

  732 

2026

  731 

2027

  731 

2028

  727 

Thereafter

  637 

Total

 $4,106 
Schedule of Accrued Liabilities [Table Text Block]
  

March 31, 2024

  

December 31, 2023

 
         

Accrued compensation

 $3,199  $4,576 

Accrued clinical and manufacturing expenses

  180   312 

Accrued professional and consulting services

  707   211 

Other liabilities, current portion

  894   535 

Total

 $4,980  $5,634

 

 

v3.24.1.1.u2
Note 6 - Liabilities Related to Sale of Future Royalties (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Deferred Revenue, by Arrangement, Disclosure [Table Text Block]

Total liability related to sale of future royalties, start of period

 $6,426 

Non-cash royalty revenue paid to HCRP

  (3,007)

Non-cash interest expense recognized

  804 

Total liability related to sale of future royalties, end of period

  4,223 

Current portion

  (2,360)

Long-term portion

 $1,863 
v3.24.1.1.u2
Note 7 - Leases (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block]

Year Ending December 31,

    

2024 (nine months remaining)

 $3,306 

2025

  4,511 

2026

  5,031 

2027

  5,207 

2028

  5,389 

Thereafter

  1,348 

Undiscounted total

  24,792 

Less: imputed interest

  (5,302)

Present value of future minimum payments

  19,490 

Current portion of operating lease liability

  (2,799)

Operating lease liability, net of current portion

 $16,691 
Lease, Cost [Table Text Block]
  

Three Months Ended March 31,

 
  

2024

  

2023

 

Lease cost

        

Operating lease cost

 $1,554  $1,510 

Short-term lease cost

  12   21 

Variable lease cost

  504   511 

Sublease income

  (14)   

Total lease cost

 $2,056  $2,042 
v3.24.1.1.u2
Note 9 - Stockholders' Equity (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Schedule of Common Stock Reserved for Issuance [Table Text Block]
  

March 31, 2024

  

December 31, 2023

 
         

Options issued and outstanding

  21,843,566   17,938,726 

RSUs issued and outstanding

  3,313,997   2,126,373 

2019 Equity Incentive Plan available for future grant

  1,404,517   5,685,806 

2024 Inducement Award Plan available for future grant

  1,750,000    

Common stock warrants

  211,259   227,434 

2022 Employee Stock Purchase Plan available for issuance

  1,065,325   1,065,325 

Total

  29,588,664   27,043,664 
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]

Securities into which warrants are convertible

 

Warrants Outstanding

  

Exercise Price

 

Expiration Date

          

Common Stock

  44,148  $1.10 

April 2024

Common Stock

  26,515  $1.375 

April 2024

Common Stock

  29,150  $2.50 

March 2025

Common Stock

  100,532  $3.125 

February 2025

Common Stock

  10,914  $22.99 

December 2026

Total

  211,259      
v3.24.1.1.u2
Note 10 - Equity Incentive Plans (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Share-Based Payment Arrangement, Option, Activity [Table Text Block]
          

Weighted

      

Weighted

 
  

Shares

  

Number of

  

Option Average

  

Unvested

  

RSU Average

 
  

Available

  

Options

  

Exercise

  

RSU Shares

  

Grant Date

 
  

For Grant

  

Outstanding

  

Price

  

Outstanding

  

Fair Value

 
                     

Balance as of January 1, 2024

  5,685,806   17,938,726  $2.90   2,126,373  $1.37 

Authorized under 2024 Inducement Plan

  

3,000,000

                 

Granted

  (6,555,730)  

4,734,937

  $1.16   1,820,793  $1.16 

Exercised

      (8,865) $0.78         

Released

              (429,960) $1.27 

Forfeited

 

 

981,822

   (778,613) $2.40   (203,209) $1.75 

Canceled

  42,619   (42,619) $3.35         
                     

Balance as of March 31, 2024

  3,154,517   21,843,566  $2.54   3,313,997  $1.24 
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]
  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Risk-free interest rate

  4.4%  3.5% - 3.6%

Expected term (in years)

  6.00   6.00 

Expected volatility

  129.1%  128.0%

Dividend yield

  %  %
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block]
  

Three Months Ended March 31,

 
  

2024

  

2023

 
         

Research and development

 $1,807  $1,372 

General and administrative

  2,309   1,275 

Total stock-based compensation

 $4,116  $2,647 
Schedule of Share-Based Payment Award, Employee Stock Purchase Plan, Valuation Assumptions [Table Text Block]
  

Six-Month Offering Period Ending May 31, 2024

  

Six-Month Offering Period Ended May 31, 2023

 
         

Risk-free interest rate

  5.3%  4.6%

Expected term (in years)

  0.50   0.50 

Expected volatility

  75.2%  84.7%

Dividend yield

  %  %
v3.24.1.1.u2
Note 11 - Net Loss Per Share Attributable to Common Stockholders (Tables)
3 Months Ended
Mar. 31, 2024
Notes Tables  
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]
   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Net loss

  $ (24,417 )   $ (25,140 )
                 

Shares used to compute net loss per share – basic and diluted

    168,811,095       135,213,196  
                 

Net loss per share – basic and diluted

  $ (0.14 )   $ (0.19 )
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]
   

Three Months Ended March 31,

 
   

2024

   

2023

 
                 

Options to purchase common stock

    18,034,438       14,436,046  
                 

Restricted stock units to purchase common stock

    1,977,053       1,218,200  
                 

Warrants to purchase common stock

    211,259       227,434  
                 

Employee Stock Purchase Plan

    471,638       433,328  
                 

Total potentially dilutive securities excluded from denominator of the diluted earnings per share computation

    20,694,388       16,315,008  
v3.24.1.1.u2
Note 1 - Organization and Nature of Business (Details Textual)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended
Sep. 15, 2021
USD ($)
Jan. 31, 2024
USD ($)
$ / shares
shares
Mar. 31, 2024
USD ($)
$ / shares
shares
Mar. 31, 2023
USD ($)
Number of Reportable Segments     1  
RA Capital Healthcare Fund 2024 [Member]        
Stock Issued During Period, Shares, New Issues (in shares) | shares   15,384,615 15,384,615  
Shares Issued, Price Per Share (in dollars per share) | $ / shares   $ 0.65 $ 0.65  
Gross Proceeds from Issuance of Common Stock   $ 10,000 $ 10,000  
Net Proceeds From Issuance of Common Stock   $ 9,900 9,900  
Proceeds from Issuance of Common Stock     $ 9,945 $ 0
The September 2021 ATM [Member]        
Stock Issued During Period, Shares, New Issues (in shares) | shares     7,404,672  
Open Market Sale Agreement, Maximum Aggregate Offering Price $ 100,000      
Open Market Sale Agreement, Sales Commission, Percentage 3.00%      
Proceeds from Issuance of Common Stock     $ 8,700  
Proceeds from Issuance of Common Stock, Net     $ 8,400  
v3.24.1.1.u2
Note 2 - Summary of Significant Accounting Policies (Details Textual)
$ in Millions
Mar. 31, 2024
USD ($)
Cash, Cash Equivalents, and Short-Term Investments $ 36.7
v3.24.1.1.u2
Note 3 - Fair Value of Financial Instruments (Details Textual) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Fair Value, Recurring [Member]    
Financial Liabilities Fair Value Disclosure, Total $ 0 $ 0
v3.24.1.1.u2
Note 3 - Fair Value of Financial Instruments - Financial Assets Measured on a Recurring Basis (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Money Market Funds [Member]    
Money market funds, Fair Value $ 17,710 $ 31,403
Fair Value, Recurring [Member]    
Total assets 32,586 36,361
Fair Value, Recurring [Member] | US Treasury Securities [Member]    
Investments, Fair Value Disclosure 14,876 4,958
Fair Value, Recurring [Member] | Money Market Funds [Member]    
Money market funds, Fair Value 17,710 31,403
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member]    
Total assets 17,710 31,403
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member]    
Investments, Fair Value Disclosure 0 0
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member]    
Money market funds, Fair Value 17,710 31,403
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member]    
Total assets 14,876 4,958
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member]    
Investments, Fair Value Disclosure 14,876 4,958
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member]    
Money market funds, Fair Value 0 0
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member]    
Total assets 0 0
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member]    
Investments, Fair Value Disclosure 0 0
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member]    
Money market funds, Fair Value $ 0 $ 0
v3.24.1.1.u2
Note 4 - Balance Sheet Components (Details Textual) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Dec. 31, 2023
Accounts Receivable, after Allowance for Credit Loss, Current $ 556   $ 3,008
Accounts Receivable, Allowance for Credit Loss, Current 0   0
Depreciation 900 $ 900  
Tangible Asset Impairment Charges, Total 0 0  
Operating Lease, Right-of-Use Asset 23,753   24,840
Amortization of Intangible Assets 200 $ 200  
Goodwill 4,508   4,508
Goodwill, Impairment Loss $ 0    
Intellectual Property [Member] | Minimum [Member]      
Finite-Lived Intangible Asset, Remaining Life (Year) 5 years 7 months 6 days    
Intellectual Property [Member] | Maximum [Member]      
Finite-Lived Intangible Asset, Remaining Life (Year) 3 years 9 months    
Facility in Burlingame, California [Member]      
Operating Lease, Right-of-Use Asset     3,100
Royalty [Member]      
Accounts Receivable, after Allowance for Credit Loss, Current $ 600   $ 3,000
v3.24.1.1.u2
Note 4 - Balance Sheet Components - Cash and Cash Equivalents and Investments (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Mar. 31, 2023
Dec. 31, 2022
Cash and Cash Equivalents, at Carrying Value $ 26,735   $ 46,831  
Cash and cash equivalents 26,735 $ 34,755 $ 48,434 $ 46,013
Gross Unrealized Loss (10) (1)    
Short-term investments 9,929 4,958    
Investments and Cash 36,674 39,714    
Investments and Cash, Fair Value Disclosure 36,664 39,713    
US Treasury Securities [Member]        
Cash and cash equivalents 4,947      
Amortized Cost 14,886 4,959    
Gross Unrealized Loss (10) (1)    
Estimated Fair Value 14,876 4,958    
Short-term investments 9,929 4,958    
Cash [Member]        
Cash and Cash Equivalents, at Carrying Value 4,078 3,352    
Money market funds, Fair Value 4,078 3,352    
Cash and cash equivalents 4,078 3,352    
Money Market Funds [Member]        
Cash and Cash Equivalents, at Carrying Value 17,710 31,403    
Money market funds, Fair Value 17,710 31,403    
Cash and cash equivalents $ 17,710 $ 31,403    
v3.24.1.1.u2
Note 4 - Balance Sheet Components - Prepaid Expenses and Other Current Assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Prepaid clinical and manufacturing expenses $ 1,762 $ 984
Unbilled revenue from government contracts 1,596 0
Prepaid insurance 933 258
Prepaid rent 528 488
Interest receivable 140 127
Other 2,105 958
Prepaid expenses and other current assets $ 7,064 $ 2,815
v3.24.1.1.u2
Note 4 - Balance Sheet Components - Property and Equipment, Net (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Property and equipment, gross $ 18,836 $ 18,562
Less: accumulated depreciation (7,734) (6,831)
Property and equipment, net 11,102 11,731
Laboratory Equipment [Member]    
Property and equipment, gross 13,507 13,448
Office Equipment [Member]    
Property and equipment, gross 1,105 1,105
Leasehold Improvements [Member]    
Property and equipment, gross 3,998 3,985
Construction in Progress [Member]    
Property and equipment, gross $ 226 $ 24
v3.24.1.1.u2
Note 4 - Balance Sheet Components - Intangible Assets (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Intangible assets, gross $ 5,080 $ 5,080
Less: accumulated amortization (974) (791)
Intangible assets, net 4,106 4,289
Developed Technology Rights [Member]    
Intangible assets, gross 5,000 5,000
Intellectual Property [Member]    
Intangible assets, gross $ 80 $ 80
v3.24.1.1.u2
Note 4 - Balance Sheet Components - Estimated Future Amortization Expense (Details)
$ in Thousands
Mar. 31, 2024
USD ($)
2024 (nine months remaining) $ 548
2025 732
2026 731
2027 731
2028 727
Thereafter 637
Total $ 4,106
v3.24.1.1.u2
Note 4 - Balance Sheet Components - Accrued Liabilities (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
Accrued compensation $ 3,199 $ 4,576
Accrued clinical and manufacturing expenses 180 312
Accrued professional and consulting services 707 211
Other liabilities, current portion 894 535
Total $ 4,980 $ 5,634
v3.24.1.1.u2
Note 5 - Revenue (Details Textual) - USD ($)
1 Months Ended 3 Months Ended
Jul. 31, 2023
Mar. 31, 2024
Mar. 31, 2023
Jan. 12, 2024
Dec. 31, 2023
Nov. 30, 2022
Revenues   $ 2,181,000 $ 675,000      
Income Tax Expense (Benefit)   45,000 29,000      
Government Contract Receivable, Unbilled Amounts   $ 1,596,000     $ 0  
Deferred Revenue, Current           $ 2,000,000
Foreign Tax Jurisdiction [Member] | National Tax Agency, Japan [Member]            
Royalty Withholding Tax   5.00%        
Income Tax Expense (Benefit)   $ 29,000 14,000      
Royalty [Member] | Daiichi Sankyo Collaberation and License Agreement [Member]            
Royalty Percentage   4.00%        
Revenues   $ 0 0      
Non Cash Royalty Revenue [Member]            
Revenues   585,000 278,000      
Non Cash Royalty Revenue [Member] | Daiichi Sankyo Collaberation and License Agreement [Member]            
Revenues   600,000 300,000      
Government Contract [Member]            
Revenues   1,596,000 0      
Government Assistance, Award Amount       $ 9,300,000    
Government Contract Receivable, Unbilled Amounts   1,600,000        
Grant [Member]            
Revenues   $ 0 $ 397,000      
Grants Receivable           $ 3,500,000
Grant Milestone Completion [Member]            
Revenues $ 1,500,000          
v3.24.1.1.u2
Note 6 - Liabilities Related to Sale of Future Royalties (Details Textual) - HCRP [Member] - USD ($)
$ in Millions
1 Months Ended 3 Months Ended 12 Months Ended
Apr. 30, 2016
Mar. 31, 2024
Dec. 31, 2023
Proceeds from Sale of Future Royalties, Net $ 20.0    
Royalty Interest, Covenant, Cumulative Remaining Shortfall Amount   $ 6.0 $ 7.0
Royalty Payment, Interest, First Period [Member]      
Royalty Interest, Covenant, Shortfall in Royalty Payments $ 3.0    
Royalty Interest, Percentage of Additional Royalties Due Each Year 15.00%    
Royalty Interest, Additional Royalties Due Each Year $ 1.0    
Royalty Payment, Interest, Second Period [Member]      
Royalty Interest, Covenant, Shortfall in Royalty Payments $ 2.7    
Royalty Interest, Percentage of Additional Royalties Due Each Year 15.00%    
Royalty Interest, Additional Royalties Due Each Year $ 1.0    
v3.24.1.1.u2
Note 6 - Liabilities Related to Sale of Future Royalties - Deferred Revenue Activity (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2024
Dec. 31, 2023
Current portion $ (2,360) $ (3,803)
Long-term portion 1,863 $ 2,623
HealthCare Royalty Partners III, L.P. [Member] | Royalty Arrangement [Member]    
Total liability related to sale of future royalties, start of period 6,426  
Non-cash royalty revenue paid to HCRP (3,007)  
Non-cash interest expense recognized 804  
Total liability related to sale of future royalties, end of period 4,223  
Current portion (2,360)  
Long-term portion $ 1,863  
v3.24.1.1.u2
Note 7 - Leases (Details Textual)
$ in Thousands
Mar. 31, 2024
USD ($)
Dec. 31, 2023
USD ($)
Sep. 30, 2021
USD ($)
Operating Lease, Right-of-Use Asset $ 23,753 $ 24,840  
Operating Lease, Weighted Average Discount Rate, Percent 9.80%    
Operating Lease, Weighted Average Remaining Lease Term (Year) 4 years 10 months 24 days    
Right of Use for Office and Manufacturing Facilities with Initial Terms Exceeding One Year [Member]      
Lessee, Operating Lease, Number of Right-of-Use Leases   6  
Lease for Facility in South San Francisco Commenced in Third Quarter of 2022 [Member]      
Operating Lease, Right-of-Use Asset     $ 15,000
Lease for Facility in South San Francisco Commenced in First Quarter of 2023 [Member]      
Operating Lease, Right-of-Use Asset     $ 3,100
v3.24.1.1.u2
Note 7 - Leases - Lease Liabilities Payment Obligations (Details) - USD ($)
$ in Thousands
Mar. 31, 2024
Dec. 31, 2023
2024 (nine months remaining) $ 3,306  
2025 4,511  
2026 5,031  
2027 5,207  
2028 5,389  
Thereafter 1,348  
Undiscounted total 24,792  
Less: imputed interest (5,302)  
Present value of future minimum payments 19,490  
Current portion of operating lease liability (2,799) $ (2,703)
Operating lease liability, net of current portion $ 16,691 $ 17,385
v3.24.1.1.u2
Note 7 - Leases - Operating Lease Expenses (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Operating lease cost $ 1,554 $ 1,510
Short-term lease cost 12 21
Variable lease cost 504 511
Sublease income (14) 0
Total lease cost $ 2,056 $ 2,042
v3.24.1.1.u2
Note 8 - Commitments and Contingencies (Details Textual) - USD ($)
$ in Millions
Nov. 02, 2022
Jul. 27, 2022
Mar. 31, 2024
Himmelberg V. Vaxart, Inc. et al. [Member]      
Litigation Settlement, Amount Awarded to Other Party   $ 12.0  
Payments for Legal Settlements $ 2.0    
Lease for Facility in South San Francisco, California [Member]      
Purchase Obligation     $ 3.6
v3.24.1.1.u2
Note 9 - Stockholders' Equity (Details Textual) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended
Aug. 04, 2022
Apr. 30, 2024
Jan. 31, 2024
Mar. 31, 2024
Dec. 31, 2023
Aug. 03, 2022
Preferred Stock, Shares Authorized (in shares)       5,000,000 5,000,000  
Preferred Stock, Par or Stated Value Per Share (in dollars per share)       $ 0.0001 $ 0.0001  
Preferred Stock, Shares Outstanding, Ending Balance (in shares)       0 0  
Common Stock, Shares Authorized (in shares)       250,000,000 250,000,000 150,000,000
Common Stock, Par or Stated Value Per Share (in dollars per share)       $ 0.0001 $ 0.0001  
Common Stock, Increase in Shares Authorized (in shares) 100,000,000          
Dividends, Total       $ 0    
First Set of Warrants Expiring April 2024 [Member]            
Warrant Exercise Price to be Entitled to Receive Cash Consideration, Fundamental Transaction (in dollars per share)       $ 1.1    
Warrants Expiring March 2025 [Member]            
Warrant Exercise Price to be Entitled to Receive Cash Consideration, Fundamental Transaction (in dollars per share)       2.5    
Warrants Expiring February 2025 [Member]            
Warrant Exercise Price to be Entitled to Receive Cash Consideration, Fundamental Transaction (in dollars per share)       $ 3.125    
Subsequent Event [Member]            
Class of Warrant or Right, Expirations in Period (in shares)   70,663        
RA Capital Healthcare Fund 2024 [Member]            
Stock Issued During Period, Shares, New Issues (in shares)     15,384,615 15,384,615    
Shares Issued, Price Per Share (in dollars per share)     $ 0.65 $ 0.65    
Gross Proceeds from Issuance of Common Stock     $ 10,000 $ 10,000    
Net Proceeds From Issuance of Common Stock     $ 9,900 $ 9,900    
v3.24.1.1.u2
Note 9 - Stockholders' Equity - Shares of Common Stock Reserved for Issuance (Details) - shares
Mar. 31, 2024
Feb. 27, 2024
Dec. 31, 2023
Common stock reserved for issuance (in shares) 29,588,664   27,043,664
Common Warrants [Member]      
Common stock reserved for issuance (in shares) 211,259   227,434
The 2019 Plan [Member]      
Common stock reserved for issuance (in shares) 1,404,517   5,685,806
The 2024 Inducement Award Plan [Member]      
Common stock reserved for issuance (in shares) 1,750,000 3,000,000 0
Share-Based Payment Arrangement, Option [Member]      
Common stock reserved for issuance (in shares) 21,843,566   17,938,726
Restricted Stock Units (RSUs) [Member]      
Common stock reserved for issuance (in shares) 3,313,997   2,126,373
ESPP [Member]      
Common stock reserved for issuance (in shares) 1,065,325   1,065,325
v3.24.1.1.u2
Note 9 - Stockholders' Equity - Summary of Warrants Outstanding (Details)
Mar. 31, 2024
$ / shares
shares
Securities into which warrants are convertible (in shares) 211,259
First Set of Warrants Expiring April 2024 [Member]  
Securities into which warrants are convertible (in shares) 44,148
Securities into which warrants are convertible (in dollars per share) | $ / shares $ 1.1
Second Set of Warrants Expiring April 2024 [Member]  
Securities into which warrants are convertible (in shares) 26,515
Securities into which warrants are convertible (in dollars per share) | $ / shares $ 1.375
Warrants Expiring March 2025 [Member]  
Securities into which warrants are convertible (in shares) 29,150
Securities into which warrants are convertible (in dollars per share) | $ / shares $ 2.5
Warrants Expiring February 2025 [Member]  
Securities into which warrants are convertible (in shares) 100,532
Securities into which warrants are convertible (in dollars per share) | $ / shares $ 3.125
Warrants Expiring December 2026 [Member]  
Securities into which warrants are convertible (in shares) 10,914
Securities into which warrants are convertible (in dollars per share) | $ / shares $ 22.99
v3.24.1.1.u2
Note 10 - Equity Incentive Plans (Details Textual) - USD ($)
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Mar. 28, 2024
Feb. 27, 2024
Dec. 31, 2023
Aug. 04, 2022
Jun. 16, 2021
Jun. 08, 2020
Apr. 23, 2019
Common Stock, Capital Shares Reserved for Future Issuance (in shares) 29,588,664       27,043,664        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number (in shares) 21,843,566       17,938,726        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price (in dollars per share) $ 2.54       $ 2.9        
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term (Year) 7 years 6 months 29 days                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Intrinsic Value $ 4,400,000                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Exercisable, Number (in shares) 11,444,731                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Exercise Price (in dollars per share) $ 3.02                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term (Year) 6 years 1 month 24 days                
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Aggregate Intrinsic Value $ 2,200,000                
Proceeds from Stock Options Exercised $ 7,000 $ 0              
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period (in shares) 8,865 0              
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value $ 3,000                
Share Price (in dollars per share)     $ 1.3            
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) $ 1.04 $ 0.78              
Options and RSU [Member]                  
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount $ 21,900,000                
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) 2 years 7 months 2 days                
The 2019 Plan [Member]                  
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares)           28,900,000 16,900,000 8,000,000 1,600,000
Common Stock, Capital Shares Reserved for Future Issuance (in shares) 1,404,517       5,685,806        
The 2024 Inducement Award Plan [Member]                  
Common Stock, Capital Shares Reserved for Future Issuance (in shares) 1,750,000     3,000,000 0        
The 2022 ESPP [Member]                  
Common Stock, Capital Shares Reserved for Future Issuance (in shares) 1,065,325         1,800,000      
Share Price (in dollars per share) $ 0.27 $ 0.46              
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount $ 42,000                
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in shares) 0                
v3.24.1.1.u2
Note 10 - Equity Incentive Plans - Summary of Stock Option Transactions (Details) - $ / shares
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Shares available for grant, balance (in shares) 5,685,806  
Number of options outstanding, beginning balance (in shares) 17,938,726  
Weighted average exercise price, balance (in dollars per share) $ 2.9  
Authorized under 2024 Inducement Plan (in shares) 3,000,000  
Shares available for grant, granted (in shares) (6,555,730)  
Number of options outstanding, granted (in shares) 4,734,937  
Weighted average exercise price, granted (in dollars per share) $ 1.16  
Number of options outstanding, exercised (in shares) (8,865) 0
Weighted average exercise price, exercised (in dollars per share) $ 0.78  
Number of RSUs outstanding, release (in shares) (429,960)  
Released, Weighted average grant date fair value (in dollars per share) $ 1.27  
Shares available for grant, forfeited (in shares) 981,822  
Number of options outstanding, forfeited (in shares) (778,613)  
Weighted average exercise price, forfeited (in dollars per share) $ 2.4  
Shares available for grant, canceled (in shares) 42,619  
Number of options outstanding, canceled (in shares) (42,619)  
Weighted average exercise price, canceled (in dollars per share) $ 3.35  
Shares available for grant, balance (in shares) 3,154,517  
Number of options outstanding, balance (in shares) 21,843,566  
Weighted average exercise price, balance (in dollars per share) $ 2.54  
Restricted Stock Units (RSUs) [Member]    
Number of RSUs outstanding (in shares) 2,126,373  
Balance, Weighted average grant date fair value (in dollars per share) $ 1.37  
Number of RSUs outstanding, granted (in shares) 1,820,793  
Granted, Weighted average grant date fair value (in dollars per share) $ 1.16  
Number of RSUs outstanding, forfeite (in shares) (203,209)  
Forfeited, Weighted average grant date fair value (in dollars per share) $ 1.75  
Number of RSUs outstanding (in shares) 3,313,997  
Balance, Weighted average grant date fair value (in dollars per share) $ 1.24  
v3.24.1.1.u2
Note 10 - Equity Incentive Plans - Assumptions of Options (Details) - Share-Based Payment Arrangement, Option [Member]
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Risk-free interest rate 4.40%  
Expected term (in years) (Year) 6 years 6 years
Expected volatility 129.10% 128.00%
Dividend yield 0.00% 0.00%
Minimum [Member]    
Risk-free interest rate   3.50%
Maximum [Member]    
Risk-free interest rate   3.60%
v3.24.1.1.u2
Note 10 - Equity Incentive Plans - Total Stock-based Compensation Recognized for Options (Details) - USD ($)
$ in Thousands
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Stock-based compensation $ 4,116 $ 2,647
Research and Development Expense [Member]    
Stock-based compensation 1,807 1,372
General and Administrative Expense [Member]    
Stock-based compensation $ 2,309 $ 1,275
v3.24.1.1.u2
Note 10 - Equity Incentive Plans - Assumptions of Employee Purchase Plan (Details) - The 2022 ESPP [Member]
6 Months Ended
May 31, 2024
May 31, 2023
Risk-free interest rate   4.60%
Expected term (in years) (Year)   6 months
Expected volatility   84.70%
Dividend yield   0.00%
Forecast [Member]    
Risk-free interest rate 5.30%  
Expected term (in years) (Year) 6 months  
Expected volatility 75.20%  
Dividend yield 0.00%  
v3.24.1.1.u2
Note 11 - Net Loss Per Share Attributable to Common Stockholders - Calculation of Basic and Diluted Net (Loss) Income Per Share (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Net loss $ (24,417) $ (25,140)
Shares used to compute net loss per share - basic and diluted (in shares) 168,811,095 135,213,196
Net loss per share - basic and diluted (in dollars per share) $ (0.14) $ (0.19)
v3.24.1.1.u2
Note 11 - Net Loss Per Share Attributable to Common Stockholders - Summary of Antidilutive Securities (Details) - shares
3 Months Ended
Mar. 31, 2024
Mar. 31, 2023
Potentially dilutive securities excluded from denominator of the diluted earnings per share computation (in shares) 20,694,388 16,315,008
Share-Based Payment Arrangement, Option [Member]    
Potentially dilutive securities excluded from denominator of the diluted earnings per share computation (in shares) 18,034,438 14,436,046
Restricted Stock Units (RSUs) [Member]    
Potentially dilutive securities excluded from denominator of the diluted earnings per share computation (in shares) 1,977,053 1,218,200
Warrant [Member] | Common Stock [Member]    
Potentially dilutive securities excluded from denominator of the diluted earnings per share computation (in shares) 211,259 227,434
Employee Stock Purchase Plan [Member]    
Potentially dilutive securities excluded from denominator of the diluted earnings per share computation (in shares) 471,638 433,328
v3.24.1.1.u2
Note 12 - Subsequent Events (Details Textual) - Subsequent Event [Member] - September 2021 ATM [Member]
$ in Millions
1 Months Ended
May 13, 2024
USD ($)
shares
Stock Issued During Period, Shares, New Issues (in shares) | shares 314,969
Proceeds from Issuance of Common Stock | $ $ 0.4

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