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 December 31, 2017

or

For the quarterly period ended September 30, 2023

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

  

For the transition period from toVaxart, Inc.

(Exact Name of Registrant as Specified in its Charter)

Commission file number: 001-35285


Aviragen Therapeutics, Inc.

(Exact name of registrant as specified in its charter)


 

Delaware

  

59-121226459-1212264

(State or other jurisdiction of

incorporation or organization)

  

(I.R.S.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)

 

2500 Northwinds Parkway, Suite 100, Alpharetta, GA 30009

(AddressSecurities registered pursuant to Section 12(b) of principal executive offices, including zip code)the Act:

 

(678) 221 3343
(Registrant’s telephone number, including area code)


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 and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post 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,”filer” and “smaller reporting company,”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 

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes   ☐     No    ☒

 

The numberRegistrant had 152,038,840 shares of shares outstanding of the registrant’s common stock, $0.0001 par value, $0.10 per share at February 5, 2018 was 38,649,237 shares. outstanding as of November 1, 2023.



 

1

 

 

Table of ContentsFORM 10-Q

FOR THE QUARTER ENDED September 30, 2023

TABLE OF CONTENTS

 

Page

Part I

PART I: FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Item 1.  Financial Statements

Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2017 and June 30, 2017 (unaudited)2022

3

1

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Threethree and Six Months Ended December 31, 2017nine months ended September 30, 2023 and 2016 (unaudited)2022

4

2

Condensed Consolidated StatementStatements of StockholdersStockholders’ Equity for the Six Monthsthree and nine months ended December 31, 2017 (unaudited)September 30, 2023 and 2022

5

3

Condensed Consolidated Statements of Cash Flows for the Six Months Ended December 31, 2017nine months ended September 30, 2023 and 2016 (unaudited)2022

6

5

Notes to the Condensed Consolidated Financial Statements (unaudited)

7

6

Item 2.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

14

15

Item 3.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

24

19Item 4.

Controls and Procedures

25

Part II

Item 4.  Controls and Procedures

20

PART II: OTHER INFORMATION

21

26

Item 1.

Item 1. Legal Proceedings

21

26

Item 1A.

Risk Factors

21

26

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds and Issuer Purchases of Equity Securities

21

27

Item 3.

Defaults Upon Senior Securities

21

27

Item 4.

Mine Safety DisclosureDisclosures

21

27

Item 5.

Other Information

27

21Item 6.

Exhibits

28

Item 6.  ExhibitsSIGNATURES

21

29

Signatures

22

Exhibit Index

23

 

2

 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Quarterly Report”) for the quarterly period ended September 30, 2023, 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, 2022, 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.I FINANCIAL INFORMATION

ITEM

Item 1.  Financial Statements

 

Aviragen Therapeutics, Inc.VAXART, INC.

Condensed Consolidated Balance Sheets

(unaudited) (In thousands, except share and per share amounts)

(in millions, except share amounts)

(Unaudited)

 

  

December 31, 2017

  

June 30, 2017

 
         

ASSETS

 

Current assets:

        

Cash and cash equivalents

 $29.4  $17.7 

Short-term investments

  -   20.9 

Accounts receivable, net of allowance

  2.5   0.6 

Prepaid and other current assets

  0.5   0.7 

Total current assets

  32.4   39.9 

Non-current assets:

        

Property and equipment, net

  0.2   0.2 

Total assets

 $32.6  $40.1 
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

Current liabilities:

        

Accounts payable

 $1.7  $1.4 

Accrued expenses

  2.5   2.9 

Short-term note payable

  0.3   0.2 

Liability related to sale of future royalties, current portion

  1.2   1.4 

Total current liabilities

  5.7   5.9 

Non-current liabilities:

        

Long-term note payable, net of current portion

  -   0.1 

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

  16.0   15.3 

Other long-term liabilities, net of current portion

  0.1   0.1 

Total liabilities

  21.8   21.4 
         

Commitments and contingencies

  -   - 

Stockholders’ equity:

        

Preferred stock, $0.10 par value: 5,000,000 shares authorized, no shares issued and outstanding

  -   - 

Common stock, $0.10 par value: 200,000,000 shares authorized; 38,649,237 shares issued and outstanding at December 31, 2017 and June 30, 2017

  3.9   3.9 

Additional paid-in capital

  160.4   159.6 

Accumulated other comprehensive income

 

19.0

  

19.0

 

Accumulated deficit

  (172.5

)

  (163.8

)

Total stockholders’ equity

  10.8   18.7 

Total liabilities and stockholders’ equity

 $32.6  $40.1 
  

September 30, 2023

  

December 31, 2022

 

Assets

        

Current assets:

        

Cash, cash equivalents and restricted cash

 $

33,238

  $46,013 

Short-term investments

  19,799   49,704 

Accounts receivable

  424   20 

Prepaid expenses and other current assets

  3,639   3,714 
         

Total current assets

  57,100   99,451 
         

Property and equipment, net

  12,926   15,585 

Right-of-use assets, net

  25,753   25,715 

Intangible assets, net

  4,472   5,020 

Goodwill

  4,508   4,508 

Other long-term assets

  883   3,568 
         

Total assets

 $105,642  $153,847 
         

Liabilities and Stockholders’ Equity

        

Current liabilities:

        

Accounts payable

 $1,339  $5,514 

Deferred grant revenue

  79   2,000 

Other accrued current liabilities

  5,991   8,084 

Current portion of operating lease liability

  2.517   2,228 

Current portion of liability related to sale of future royalties

  1,342   95 
         

Total current liabilities

  11,268   17,921 
         

Operating lease liability, net of current portion

  17,942   19,477 

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

  4,633   5,621 

Other long-term liabilities

  278   231 
         

Total liabilities

  34,121   43,250 
         

Commitments and contingencies (Note 8)

          
         

Stockholders’ equity:

        

Preferred stock: $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding as of September 30, 2023 and December 31, 2022

      

Common stock: $0.0001 par value; 250,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 152,081,196 shares issued and 152,037,358 shares outstanding as of September 30, 2023 and 134,199,429 shares issued and outstanding as of December 31, 2022

  15   13 

Additional paid-in capital

  463,755   437,992 

Treasury stock at cost, 43,838 shares as of September 30, 2023 and none as of December 31, 2022, respectively

  (39)   

Accumulated deficit

  (392,199)  (327,109)

Accumulated other comprehensive loss

  (11)  (299)
         

Total stockholders’ equity

  71,521   110,597 
         

Total liabilities and stockholders’ equity

 $105,642  $153,847 

 

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

 

3
1

Aviragen Therapeutics, Inc.

CondensedConsolidated Statements of Operations

(unaudited)
(in millions, except share and per share amounts)

  

Three Months Ended
December 31,

  

Six Months Ended
December 31,

 
  

2017

  

2016

  

2017

  

2016

 

Revenue:

                

Royalty revenue

 $-  $1.5  $-  $1.6 

Non-cash royalty revenue related to the sale of future royalties

  2.7   2.3   2.8   2.3 

Total revenue

  2.7   3.8   2.8   3.9 
                 

Operating expense:

                

Research and development

  2.5   10.2   5.3   17.8 

General and administrative

  3.1   2.1   5.4   4.3 

Foreign exchange (gain) loss, net

  -   0.1   -   - 

Total operating expense

  5.6   12.4   10.7   22.1 

Loss from operations

  (2.9

)

  (8.6

)

  (7.9

)

  (18.2

)

Other (expense) income:

                

Non-cash interest expense on liability related to sale of future royalties

  (0.4

)

  (0.5

)

  (0.8

)

  (0.9

)

Interest income

  -   0.1   0.1   0.1 

Total other (expense) income

  (0.4

)

  (0.4

)

  (0.7

)

  (0.8

)

                 

Loss before tax

  (3.3

)

  (9.0

)

  (8.6

)

  (19.0

)

Income tax expense

  0.1   0.1   0.1   0.1 

Net loss

 $(3.4

)

 $(9.1

)

 $(8.7

)

 $(19.1

)

                 
                 

Basic and diluted net loss per share

 $(0.09

)

 $(0.24

)

 $(0.23

)

 $(0.49

)

                 

Basic and diluted weighted-average shares outstanding

  38,649,237   38,640,487   38,649,237   38,640,487 

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

 

 

Aviragen Therapeutics, Inc.

CondensedVAXART, INC.ConsolidatedStatement of Stockholders’ Equity
(unaudited)

(in millions, except for share amounts)

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

  

Common Stock

          

Accumulated

     
  

Shares

  

Amount

  

Additional

Paid-in

Capital

  

Accumulated

Deficit

  

Other

Comprehensive

Income

  

Total

Stockholders

Equity

 

Balances at June 30, 2017

  38,649,237  $3.9  $159.6  $(163.8

)

 $19.0  $18.7 

Net loss

  -   -   -   (8.7

)

  -   (8.7

)

Share-based compensation

  -   -   0.8   -   -   0.8 

Balances at December 31, 2017

  38,649,237  $3.9  $160.4  $(172.5

)

 $19.0  $10.8 
  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 

Revenue:

                

Non-cash royalty revenue related to sale of future royalties

 $446  $  $754  $85 

Grant revenue

  1,655      3,380    
                 

Total revenue

  2,101      4,134   85 
                 

Operating expenses:

                

Research and development

  15,002   22,466   53,437   60,595 

General and administrative

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

Total operating expenses

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

Operating loss

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

Other income (expense):

                

Interest income

  723   458   2,076   650 

Non-cash interest expense related to sale of future royalties

  (207)  (325)  (573)  (988)

Other expense, net

  (55)     (59)  (2)
                 

Loss before income taxes

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

Provision for income taxes

  39   16   87   51 
                 

Net loss

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

Net loss per share - basic and diluted

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

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

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

Comprehensive loss:

                

Net loss

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

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

  13   (109)  288   (444)

Comprehensive loss

 $(17,387) $(29,418) $(64,802) $(84,284)

 

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

 

 

 

Aviragen Therapeutics, Inc.

Condensed Consolidated Statements of Cash FlowsVAXART, INC.

(unaudited)
(in millions)

 

Condensed Consolidated Statements of Stockholders’ Equity

For the Three and Nine Months Ended September 30, 2023

(In thousands, except share amounts)

(Unaudited)

 

  

Six Months Ended
December 31,

 
  

2017

  

2016

 
         
         

Cash flows from operating activities:

        

Net loss

 $(8.7

)

 $(19.1

)

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

        

Share-based compensation

  0.8   0.9 

Non-cash interest expense related to sale of future royalties

  0.8   0.9 

Non-cash royalty revenue related to sale of future royalties, net of withholding tax

  (2.7

)

  (2.3

)

         

Change in operating assets and liabilities:

        

Accounts receivables

  0.3   (1.4

)

Prepaid expenses and other current assets

  0.2   (0.1

)

Accounts payable and accrued expenses

  0.1   1.4 
         

Net cash used in operating activities

  (9.2

)

  (19.7

)

         

Cash flows from investing activities:

        

Purchases of short and long-term investments

  (7.0

)

  (8.4

)

Maturities of short-term investments

  27.9   16.6 
         

Net cash provided by investing activities

 

20.9

   8.2 
         

Cash flows from financing activities:

        

Payment on note payable

  -   (0.1

)

         

Net cash used in financing activities

  -   (0.1

)

         

Increase (decrease) in cash and cash equivalents

  11.7   (11.6

)

Cash and cash equivalents at beginning of period

  17.7   49.7 
         

Cash and cash equivalents at end of period

 $29.4  $38.1 
                          

Accumulated

     
                  

Additional

      

Other

  

Total

 
  

Common Stock

  

Treasury Stock

  

Paid-in

  

Accumulated

  

Comprehensive

  

Stockholders’

 

Three Months Ended September 30, 2023

  Shares   Amount   Shares   Amount  Capital   Deficit   (Loss) Gain   Equity 
                                 

Balances as of June 30, 2023

  152,016,238  $15   (33,246) $(31) $459,912  $(374,799) $(24) $85,073 
                                 
Release of common stock for vested restricted stock units  64,958                      
                                 

Repurchase of common stock to satisfy tax withholding

        (10,592)  (8)           (8)
                                 

Stock-based compensation

              3,843         3,843 
                                 

Unrealized gains on available-for-sale investments

                    13   13 
                                 

Net loss

                 (17,400)     (17,400)
                                 

Balances as of September 30, 2023

  152,081,196  $15   (43,838) $(39) $463,755  $(392,199) $(11) $71,521 
                                 

Nine Months Ended September 30, 2023

                                
                                 

Balances as of December 31, 2022

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

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

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

Issuance of common stock under 2023 Shelf Registration, net of offering costs of $284

  16,000,000   1         13,602         13,603 
                                 

Issuance of common stock upon exercise of stock options

  54,720            17         17 
                                 

Issuance of common stock under ESPP

  301,061            298         298 
                                 

Release of common stock for vested restricted stock units

  163,766                      
                                 

Repurchase of common stock to satisfy tax withholding

        (43,838)  (39)           (39)
                                 

Stock-based compensation

              10,417         10,417 
                                 

Unrealized gains on available-for-sale investments

                    288   288 
                                 

Net loss

                 (65,090)     (65,090)
                                 

Balances as of September 30, 2023

  152,081,196  $15   (43,838) $(39) $463,755  $(392,199) $(11) $71,521 

 

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

 

VAXART, INC.

 

Aviragen Therapeutics, Inc.Condensed Consolidated Statements of Stockholders’ Equity

For the Three and Nine Months Ended September 30, 2022

(In thousands, except share amounts)

(Unaudited)

                  

Accumulated

     
          

Additional

      

Other

  

Total

 
  

Common Stock

  

Paid-in

  

Accumulated

  

Comprehensive

  

Stockholders’

 

Three Months Ended September 30, 2022

  Shares   Amount  Capital   Deficit   Loss   Equity 
                         

Balances as of June 30, 2022

  126,446,036  $13  $417,372  $(273,882) $(409) $143,094 
                         

Issuance of common stock under September 2021 ATM, net of offering costs of $161

  1,789,022      4,853         4,853 
                         

Issuance of common stock upon exercise of stock options

  96,350      135         135 
                         

Stock-based compensation

        3,643         3,643 
                         

Unrealized losses on available-for-sale investments

              (109)  (109)
                         

Net loss

           (29,309)     (29,309)
                         

Balances as of September 30, 2022

  128,331,408  $13  $426,003  $(303,191) $(518) $122,307 
                         

Nine Months Ended September 30, 2022

                        
                         

Balances as of December 31, 2021

  125,594,393  $13  $406,943  $(219,351) $(74) $187,531 
                         

Issuance of common stock under September 2021 ATM, net of offering costs of $583

  2,565,022      8,650         8,650 
                         

Issuance of common stock upon exercise of warrants

  5,000      2         2 
                         

Issuance of common stock upon exercise of stock options

  166,993      214         214 
                         

Stock-based compensation

        10,194         10,194 
                         

Unrealized losses on available-for-sale investments

              (444)  (444)
                         

Net loss

           (83,840)     (83,840)
                         

Balances as of September 30, 2022

  128,331,408  $13  $426,003  $(303,191) $(518) $122,307 

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)

  

Nine Months Ended September 30,

 
  

2023

  

2022

 
         

Cash flows from operating activities:

        

Net loss

 $(65,090) $(83,840)

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

        

Depreciation and amortization

  6,293   3,915 
Loss on disposal of equipment  55    

Amortization of discount on investments, net

  

(510

)  (13)

Stock-based compensation

  10,417   10,194 

Non-cash interest expense related to sale of future royalties

  573   988 

Non-cash revenue related to sale of future royalties

  (314)  (152)

Change in operating assets and liabilities:

        

Accounts receivable

  (404)  71 

Prepaid expenses and other assets

  2,760   (4,037)

Accounts payable

  (2,699)  2,528 

Deferred grant revenue

  (1,921)   

Other accrued liabilities

  (6,092)  4,719 
         

Net cash used in operating activities

  (56,932)  (65,627)
         

Cash flows from investing activities:

        

Purchases of property and equipment

  (1,975)  (5,700)

Proceeds from sale of property and equipment

  120    

Cash paid for right-of-use assets

     (5,038)

Purchases of investments

  (27,497)  (48,178)

Proceeds from maturities of investments

  58,200   22,700 
         

Net cash provided by (used in) investing activities

  28,848   (36,216)
         

Cash flows from financing activities:

        

Net proceeds from issuance of common stock in registered direct offering

  13,603    

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

  1,430   8,650 

Proceeds from issuance of common stock upon exercise of warrants

     2 

Shares acquired to settle employee tax withholding liabilities

  (39)   

Proceeds from issuance of common stock upon exercise of stock options

  17   214 

Proceeds from issuance of common stock under the employee stock purchase plan

  298    
         

Net cash provided by financing activities

  15,309   8,866 
         

Net decrease in cash, cash equivalents and restricted cash

  (12,775)  (92,977)
         

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

  46,013   143,745 
         

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

 $33,238  $50,768 

         

Supplemental disclosure of non-cash investing and financing activity:

        

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

 $296  $9,997 

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

 $14  $1,738 

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

 

VAXART, INC.

Notes to the CondensedConsolidatedFinancial Statements (unaudited)(Unaudited)

NOTE 1.  Organization and Nature of Business
(for the quarterly period ended December 31, 2017)

 

1)

General 

Company Overview

 

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”), togetherpursuant 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 wholly owned subsidiaries, (“Aviragen”, or the “Company” or “Vaxart”) isand Private Vaxart changed its name to Vaxart Biosciences, Inc.

In June 2023, Vaxart completed an underwritten public offering (the “June 2023 Offering”) in which 16,000,000 shares of its common stock were sold at an offering price of $0.8680 per share pursuant to the Company’s effective shelf registration statement on Form S-3 (the “2023 Shelf Registration”). The net proceeds from the June 2023 Offering were $13.6 million after deducting underwriting discounts and commission and estimated offering expenses payable by Vaxart.

On September 15, 2021, the Company entered into a biopharmaceutical company focusedControlled 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 U.S. Securities and Exchange Commission (the “SEC”) onSeptember 16, 2021, and 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.

During the nine months ended September 30, 2023, 1,362,220 shares were issued and sold under the September 2021 ATM for gross proceeds of $1.5 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $1.4 million. Since September 30,2023, the Company has not raised any additional capital under the September 2021 ATM.

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 direct-acting antivirals to treat infections that have limited therapeutic options and affect a significant numberoral recombinant protein vaccines, based on its proprietary oral vaccine platform. 

NOTE 2.  Summary of patients globally. The Company has three Phase 2 clinical stage compounds: BTA074 (teslexivir), an antiviral treatment for condyloma caused by human papillomavirus types 6 & 11; vapendavir, a capsid inhibitor for the prevention or treatment of rhinovirus upper respiratory infections; and BTA585 (enzaplatovir), a fusion protein inhibitor in development for the treatment of respiratory syncytial virus (RSV) infections. The Company also has a preclinical RSV non-fusion inhibitor program. The Company is incorporated in the state of Delaware and its corporate headquarters are located in Alpharetta, Georgia.Significant Accounting Policies

 

Although several

Basis of the Company’s influenza product candidates have been successfully developedPresentation, Liquidity and commercialized to-date by other larger pharmaceutical companies under collaboration, license or commercialization agreements with the Company, it has not independently developed or received regulatory approval for any product candidate, and the Company does not currently have any sales, marketing or commercial capabilities. Therefore, it is possible that the Company may not successfully derive any significant product revenues from any product candidates that it is developing now, or may develop in the future.Going Concern – The Company expects to incur losses for the foreseeable future as it intends to support the clinical and preclinical development of its product candidates.

On October 30, 2017, the Company announced that it had entered into a definitive Agreement and Plan of Merger and Reorganization dated as of October 27, 2017, among the Company, Agora Merger Sub, Inc. and Vaxart, Inc. (the “Merger Agreement”) pursuant to which Vaxart, a privately-held clinical-stage company focused on developing oral recombinant vaccines from its proprietary delivery platform, would become a wholly-owned subsidiary of the Company (the “Merger”). This transaction marks the culmination of the Company’s Strategic Review process which was initiated in April. The Merger will result in a clinical-stage pharmaceutical company focused on developing Vaxart’s oral recombinant vaccines and Aviragen’s direct-acting antivirals to treat infections that have limited therapeutic options.

The exchange ratio in the merger agreement was determined by Vaxart assigning $60,000,000 in value to Aviragen for its financial and clinical assets, and $90,000,000 in value for its own assets. On a pro forma basis after giving effect to the number of shares of Aviragen common stock that will be issued to Vaxart security holders in the Merger and assuming no adjustments for cash balances as provided for in the Merger Agreement, current Vaxart security holders will own approximately 60% of the combined company and current Aviragen security holders will own approximately 40% of the combined company. The transaction has been approved by the boards of directors of both companies. The Merger is expected to close in February 2018, subject to the approval of the stockholders of each company as well as other customary conditions. Upon closing of the Merger, the name of the combined company will become Vaxart, Inc. and shares of the combined company are expected to continue trading on the NASDAQ Capital Market under the proposed ticker symbol VXRT. Wouter Latour, M.D., Chief Executive Officer of Vaxart, will serve as Chief Executive Officer of the combined company.

At the end of the quarter, a small group of dissident stockholders, who call themselves the Concerned Aviragen Shareholders (“CAS”) Group, launched a proxy contest against the proposed merger with Vaxart and are seeking an opportunity to nominate individuals for election to the Company’s Board at the upcoming Annual Meeting.  The Company continues to believe the proposed merger with Vaxart is the best possible strategic alternative, and together, Aviragen and Vaxart will have the potential to create meaningful value for stockholders.

Prior to the completion of the proposed merger, the Company plans to continue to finance its operations with existing cash, cash equivalents and investments.

(2)

Basis of Presentation

The accompanying unaudited 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 September 30,2023, the Company had cash, cash equivalents, restricted cash, and investments of $53.0 million. The Company’s cash, cash equivalents, restricted cash and investments are not sufficient to fund the Company’s planned operations for interima period of 12 months from the date the financial information andstatements 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. The Company is currently not in compliance with the instructions minimum bid price requirement for continued listing on The Nasdaq Capital Market and has been provided an initial compliance period until January 17, 2024, to Formregain compliance. The Company 10may -Q and Rulebe eligible for an additional 10-01180 calendar days compliance period under certain circumstances. If the Company does not regain compliance during the compliance period, the Company’s common stock will be delisted from Nasdaq. The delisting of Regulation S-the Company's common stock from Nasdaq X.may make it more difficult for the Company to raise capital on favorable terms in the future, or at all. There can be no All material adjustments considered necessaryassurance that the Company will be successful raising additional capital. 

Based on management's current plan, the Company expects to have enough cash runway into the third 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 fair presentationperiod of one year from the date of the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been included.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, 2022, 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 disclosuredisclosures normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to instructions,these rules and regulations prescribed by the U.S. Securities and Exchange Commission (“SEC”). Except as disclosed herein, there has been no material change in the information disclosed in the notes to theregulations. These condensed consolidated financial statements included in the Company’s Annual Report on Form 10-K that was filed with the SEC on September 1, 2017.

The unaudited interim condensed consolidated financial statements include the accounts of the Company and all of its wholly owned subsidiaries. All inter-company transactions and balances are eliminated in consolidation.

Operating results for the three and six months ended December 31, 2017 are not necessarily indicative of those in future quarters or the annual results that may be expected for the Company’s fiscal year ending June 30, 2018. For a more complete discussion of the Company’s significant accounting policies and other information, this report should be read in conjunction with the consolidatedCompany’s audited financial statements and footnotes related thereto for the fiscal year ended June 30, 2017December 31,2022,included in the Company’s Annual Report on Form 10-K.

The Company’s-K filed with the SEC on March 15, 2023 (the “Annual Report”). Unless noted below, there have been no material changes to the Company’s significant accounting policies havedescribed 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 changed since June 30, 2017.necessarily indicative of the results to be expected for the full year or any future periods.

 

Recently Issued Accounting StandardsBasis of Consolidation – The 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.

 

In May 2014,

Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the FASB issued authoritative accounting guidance relatedreported 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.

6

VAXART, INC.

Notes to revenue from contracts with customers. This guidance is a comprehensive new revenue recognition modelthe Condensed Consolidated Financial Statements (Unaudited)

Concentration of Credit Risk – Financial instruments that requires a company to recognize revenue to depict the transfer of goods or services to a customer at an amount that reflects the consideration it expects to receive in exchange for those goods or services. This guidance is effective for annual reporting periods beginning after December 15, 2017. Accordingly,potentially subject the Company will adopt this guidance on July 1, 2018. Companies may use either a full retrospective or a modified retrospective approach to adopt this guidance.significant concentrations of credit risk consist principally of cash, cash equivalents, restricted cash and available-for-sale investments. The Company places its cash, cash equivalents, restricted cash and available-for-sale investments at financial institutions that management believes are of high credit quality. The Company is evaluating which transition approachexposed to usecredit risk in the event of default by the financial institutions holding the cash, cash equivalents and itsrestricted cash 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 if any, on its consolidatedthe Company’s financial statements.condition, results of operations, and cash flows.

 

InThe 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 January 2016, onethe FASB issued guidance related to financial instruments - overall recognition corporate issuer or sector and measurement of financial assets and financial liabilities. The guidance enhances the reporting model for financial instruments, which includes amendments to address aspects of recognition, measurement, presentation and disclosure. The update to the standard is effective for public companies for interim and annual periods beginning after December 15, 2017. Accordingly, the standard is effective for the Company on July 1, 2018. The Company is currently evaluating the impact that the standard will have on the consolidated financial statements.establishing a minimum allowable credit rating.

 

In

Recent Accounting Pronouncements

The Company has reviewed all newly-issued accounting pronouncements that are February 2016, notthe FASB issued new guidance on leases. This guidance replaces the prior lease accounting guidance in yet effective and concluded that they are either not applicable to its entirety. The underlying principle of the new standard is the recognition of lease assets and lease liabilities by lessees for substantially all leases, with an exception for leases with terms of less than twelve months. The standard also requires additional quantitative and qualitative disclosures. The guidance is effective for interim and annual reporting periods beginning after December 15, 2018, and earlyoperations or their adoption is permitted. The standard requires a modified retrospective approach, which includes several optional practical expedients. Accordingly, the standard is effective for the Company on July 1, 2019. The Company is currently evaluating the impact that this guidance will have on the consolidated financial statements.

In August 2016, the FASB issued new guidance on how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The standard is effective for the Company beginning July 1, 2018. Early adoption is permitted. We do not expect the adoption of this guidanceexpected to have a material impact on the consolidatedits financial statements.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 financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, marketable securities, accounts receivable and accounts payable that approximate fair value due to their relatively short maturities.

(3)

Fair Value Measurements

 

AAssets and liabilities recorded at fair value hierarchy has been established that requireson a recurring basis in the Companybalance sheets are categorized based upon the level of judgment associated with inputs used to maximize the use of observable inputs, where available, and minimize the use of unobservable inputs whenmeasure their fair values. The accounting guidance for fair value provides a framework for measuring fair value. Thevalue and requires certain disclosures about how fair value hierarchy describesis 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 levels of-level valuation hierarchy that prioritizes the inputs that may beto valuation techniques used to measure fair value: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.

 

Level 1

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

Quoted prices in active markets for identical assets or liabilities.

 

the related assets or liabilities; and

 

Level 2

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.

Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices 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 assets or liabilities.

Level 3

Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

The following table sets forth the fair value of the Company’s financial assets and liabilities that wereare measured at fair value on a recurring basis at as of September 30, 2023 and December 31, 2017 2022and June 30, 2017, by level within the fair value hierarchy. The assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. (in thousands):

  

Level 1

  

Level 2

  

Level 3

  

Total

 

September 30, 2023

                

Financial assets:

                

Money market funds

 $27,975  $  $  $27,975 

U.S. Treasury securities

     19,799      19,799 

Total

 $27,975  $19,799  $  $47,774 

  

Level 1

  

Level 2

  

Level 3

  

Total

 

December 31, 2022

                

Financial assets:

                

Money market funds

 $30,834  $  $  $30,834 

U.S. Treasury securities

     41,542      41,542 

Commercial paper

     5,674      5,674 

Corporate debt securities

     2,488      2,488 

Total

 $30,834  $49,704  $  $80,538 

 

The Company’s short-term investments held no recurring financial liabilities as of JuneSeptember 30, 2017 have been classified as Level2023, or 2,December 31, 2022 which have been initially valued at the transaction price and subsequently revalued, at the end of each reporting period, utilizing a third party pricing service. The pricing service utilizes industry standard valuation models and observable market inputs to determine value that include surveying the bond dealer community, obtaining benchmark quotes, incorporating relevant trade data, and updating spreads daily. There have been no transfers of assets or liabilities between the fair value measurement classifications..

 

      

Quoted Prices in

  

Significant

     
      

Active Markets

  

Other

  

Significant

 

(in millions)

     

for Identical Assets

  

Observable Inputs

  

Unobservable Inputs

 

December 31, 2017

 

Total

  

(Level 1)

  

(Level 2)

  

(Level 3)

 

Cash equivalents

 $18.7  $7.0  $11.7  $ 

Short-term investments available-for-sale

            

Total

 $18.7  $7.0  $11.7  $ 

(in millions)    

Quoted Prices in

Active Markets

for Identical Assets

  

Significant

Other

Observable Inputs

  

Significant 

Unobservable 

Inputs 

 

June 30, 2017

 

Total

  

(Level 1)

  

(Level 2)

  

(Level 3)

 

Cash equivalents

 $10.9  $5.9  $5.0  $ 

Short-term investments available-for-sale

 

20.9

      20.9    

Total

 $31.8  $5.9  $25.9  $ 

Cash equivalents consist primarily of money market funds, corporate notes and commercial paper with original maturities of 90 or fewer days when purchased. Short-term investments consist of certificates of deposit, corporate securities, U.S. Treasury securities andU.S. agency securities, classified as available-for-sale and have maturities less than 365 days from the date of acquisition.

The following table shows the unrealized gains and losses and fair values for those investments as of December 31, 2017 and June 30, 2017 aggregated by major security type:

(in millions)

     

Unrealized

  

Unrealized

     

December 31, 2017

 

At Cost

  

Gains

  

(Losses)

  

At Fair Value

 

Money market funds

 $7.0  $-  $-  $7.0 

Corporate notes

  6.5   -   -   6.5 

Commercial paper

  5.2   -   -   5.2 

Total

 $18.7  $-  $-  $18.7 

97

(in millions)

     

Unrealized

  

Unrealized

     

June 30, 2017

 

At Cost

  

Gains

  

(Losses)

  

At Fair Value

 

Money market funds

 $5.9  $  $  $5.9 

Commercial paper

  8.5         8.5 

Corporate notes

  17.4         17.4 

Total

 $31.8  $  $  $31.8 

VAXART, INC.

 

AsNotes to the Condensed Consolidated Financial Statements (Unaudited)

NOTE 4.  Balance Sheet Components

(a)

Cash, Cash Equivalents, Restricted Cash and Investments

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

  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and Cash Equivalents

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

and Restricted Cash

  

Investments

 

September 30, 2023

                        

Cash at banks

 $5,263  $  $  $5,263  $5,263  $ 

Money market funds

  27,975         27,975   27,975    

U.S. Treasury securities

  19,810      (11)  19,799      19,799 

Total

 $53,048  $  $(11) $53,037  $33,238  $19,799 

  

Amortized

  

Gross Unrealized

  

Estimated

  

Cash and Cash Equivalents

  

Short-Term

 
  

Cost

  

Gains

  

Losses

  

Fair Value

  

and Restricted Cash

  

Investments

 

December 31, 2022

                        

Cash at banks

 $15,179  $  $  $15,179  $15,179  $ 

Money market funds

  30,834         30,834   30,834    

U.S. Treasury securities

  41,812      (270)  41,542      41,542 

Commercial paper

  2,488         2,488      2,488 

Corporate debt securities

  5,703      (29)  5,674      5,674 

Total

 $96,016  $  $(299) $95,717  $46,013  $49,704 

Cash and cash equivalents and restricted cash of $33.2 million as of September 30, 2023 and $46.0 million as of December 31, 20172022, includes restricted cash of $79,000 and June 30, 2017, the Company had investments in an unrealized gain (loss) position below material disclosure thresholds in the table above. The Company determined that the unrealized gains$2.0 million, respectively.

(b)

Property and Equipment, Net

Property and losses on these investments were temporary in nature and expected the security to mature at its stated maturity principal. All available-for-sale securities held at December 31, 2017, will mature in less than one year. The fair value of cash, accounts receivable, accounts payable and accrued liabilities approximate their carrying value becauseequipment, net consists of the short-term nature of these financial instruments at following (in thousands):

  

September 30, 2023

  

December 31, 2022

 
         

Laboratory equipment

 $13,638  $12,035 

Office and computer equipment

  1,105   1,078 

Leasehold improvements

  4,098   1,760 

Construction in progress

  27   3,984 

Total property and equipment

  18,868   18,857 

Less: accumulated depreciation

  (5,942)  (3,272)

Property and equipment, net

 $12,926  $15,585 

Depreciation expense was $1.0 million and $0.5 million for the December 31, 2017three months ended September 30,2023and June 2022, respectively, and $2.8 million and $1.3 million for the nine months ended September 30, 2017, respectively. The fair value2023 and 2022, respectively. There were no material impairments of the Company’s short-term note payable, which is measured using Levelproperty and equipment recorded in the 2nine inputs, approximates book value, atmonths ended September 30,2023, or 2022, respectively.

(c)

Right-of-Use Assets, Net

Right-of-use assets, net comprises facilities of $25.8 million and $25.7 million as of September 30, 2023 and December 31, 2022, 2017and June 30, 2017.

(4)   Accrued and Other Current Liabilitiesrespectively. 

 

(d)

Intangible Assets, Net

Accrued expenses

Intangible assets comprise developed technology and intellectual property. Intangible assets are carried at cost less accumulated amortization. Amortization is computed using the straight-line method over useful life of 11.75 years for developed technology and 20 years for intellectual property. As of September 30,2023, developed technology and intellectual property had remaining lives of 6.1 and 4.25 years, respectively. As of September 30, 2023, there have been no indicators of impairment. Intangible assets consist of the following (in millions)thousands):

 

  

December 31, 2017

  

 

June 30, 2017

 
         

Professional fees

 $0.7  $0.4 

Salary and benefits

  1.3   0.4 

Research and development expenses

  0.5   1.8 

Other accrued expenses

  -   0.3 

Total accrued expenses and other liabilities

 $2.5  $2.9 
  

September 30, 2023

  

December 31, 2022

 
         

Developed technology

 $5,000  $5,000 

Intellectual property

  80   80 

Total cost

  5,080   5,080 

Less: accumulated amortization

  (608)  (60)

Intangible assets, net

 $4,472  $5,020 

  

8

(5)     Liabilities Related to Sale of Future RoyaltiesVAXART, INC.

 

In April 2016, the Company sold certain royalty rights relatedNotes to the approved productCondensed Consolidated Financial Statements (Unaudited)

Intangible asset amortization expense for the three months ended September 30,2023 and 2022, was $0.2 million and $0.3 million, respectively, and for the nine months ended September 30, 2023 and 2022, $0.5 million and $1.0 million respectively.

As of September 30,2023, the estimated future amortization expense by year is as follows (in thousands):

Year Ending December 31,

 

Amount

 

2023 (three months remaining)

 $183 

2024

  731 

2025

  731 

2026

  731 

2027

  731 

Thereafter

  1,365 

Total

 $4,472 

(e)

Goodwill

Goodwill, which represents the excess of the purchase price over the fair value of assets acquired, comprises $4.5 million as of September 30, 2023 and December 31, 2022. As of September 30, 2023, there have been no indicators of impairment.

(f)

Other Accrued Liabilities

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

  

September 30, 2023

  

December 31, 2022

 
         

Accrued compensation

 $4,573  $3,112 

Accrued clinical and manufacturing expenses

  535   2,413 

Accrued professional and consulting services

  306   691 

Other liabilities, current portion

  577   1,868 

Total

 $5,991  $8,084 

NOTE 5.  Revenue

Royalty Agreement

The Company generates royalty revenue from the sale of Inavir®, sold by 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 market,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. The last patent related to Inavir is set to expire in $20December 2029, 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 in the nine months ended September 30,2023 and 2022, was nil. In addition, the Company recognized non-cash royalty revenue related to sale of future royalties (see Note 6) of $0.4 million and nil in the three months ended September 30,2023 and 2022, respectively, and $0.8 million and $85,000 in the nine months ended September 30,2023 and 2022, respectively. Both royalty revenue and the non-cash royalty revenue related to sale of future royalties are subject to a 5% withholding tax in Japan, for which $23,000 and nil was included in income tax expense in the three months ended September 30,2023 and 2022, respectively, and $38,000 and $4,000 in the nine months ended September 30,2023 and 2022, respectively.

Grant Revenue

In November 2022, the Company accepted a grant (the “BMGF Grant”) to perform research and development work for the Bill & Melinda Gates Foundation (“BMGF”) 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 has been executed and the contract price is fixed or determinable. Revenue from the BMGF Grant is recognized in the period during which the related costs are incurred and the related services are rendered, provided that the applicable conditions under the contract have been met. Costs of contract revenue are 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 $1.7 million and $3.4 million in the three and nine months ended September 30,2023, respectively. As of September 30, 2023 and December 31, 2022, restricted cash and deferred revenue were $79,000 and $2.0 million, respectively.

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, HCRP is entitled to the first $3.0 million 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.

9

VAXART, INC.

Notes to the Condensed Consolidated Financial Statements (Unaudited)

Under the relevant accounting guidance, due to a limit on the amount of royalties that HCRP can earn under the arrangement,RIAA, this transaction was accounted for as a liability that will beis 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. In order toTo 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 with Daiichi Sankyo and the payments that will be passed through to HCRP over the life of thethis agreement. The sum of the pass through amounts less the net proceeds received will be recorded as non-cash interest expense over the life of the liability. 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 will periodically assessassesses the expected royalty payments, and to the extent such payments are greater or less than the initial estimate, the Company will adjustadjusts 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, andincluding the related interest, is fully amortized.

 

The following table shows the activity within the liability account during the sixnine months ended December 31, 2017:September 30,2023 (in thousands):

 

 

in millions

 

Total Liability related to sale of future royalties, June 30, 2017

 $16.7 

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

 $5,716 

Non-cash royalty revenue paid to HCRP

  (0.3) (314)

Non-cash interest expense recognized

  0.8   573 

Total Liability related to sale of future royalties, December 31, 2017

 $17.2 

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

 5,975 

Current portion

  (1,342)

Long-term portion

 $4,633 

  

 

(NOTE 67)   Net Loss per share.  Leases

 

BasicThe Company has obtained the right of use for office and manufacturing facilities under seven operating lease agreements with initial terms exceeding one year and has one operating lease agreement for facilities and one for manufacturing equipment with initial terms of one year or less. 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 September 30, 2023, 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 5.4 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 twelve months as of September 30, 2023 (in thousands):

Year Ending December 31,

    

2023 (three months remaining)

 $1,043 

2024

  4,275 

2025

  4,421 

2026

  4,975 

2027

  5,205 
2028  

5,387

 

Thereafter

  1,410 

Undiscounted total

  26,716 

Less: imputed interest

  (6,257)

Present value of future minimum payments

  20,459 

Current portion of operating lease liability

  (2,517)

Operating lease liability, net of current portion

 $17,942 

The Company has a future payment obligation of up to $0.2 million that is not reflected in the table above relating to a lease agreement that has not yet commenced but was executed as of September 30, 2023. The Company presently has no finance leases and no future obligations under operating leases with initial terms of one year or less.

10

VAXART, INC.

Notes to the Condensed Consolidated Financial Statements (Unaudited)

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 and nine months ended September 30, 2023, and 2022 are summarized as follows (in thousands):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 

Lease cost

                

Operating lease cost

 $1,554  $1,202  $4,617  $2,652 

Short-term lease cost

  10   117   41   335 

Variable lease cost

  459   397   1,401   926 

Total lease cost

 $2,023  $1,716  $6,059  $3,913 

NOTE 8.  Commitments and Contingencies

(a)

Purchase Commitments

As of September 30, 2023, the Company had approximately $4.8 million of non-cancelable purchase commitments, principally for contract manufacturing and clinical services which are expected to be paid within the next year. 

(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.

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.

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.

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.

11

VAXART, INC.

Notes to the Condensed Consolidated Financial Statements (Unaudited)

(b)

Common Stock

As of September 30,2023, 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 September 30, 2023, no dividends had been declared by the board of directors.

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:

  

September 30, 2023

  

December 31, 2022

 
         

Options issued and outstanding

  18,073,909   14,725,261 

RSUs issued and outstanding

  3,594,698   808,310 

Available for future grants of equity awards

  5,527,341   12,074,692 

Common stock warrants

  227,434   227,434 

2022 Employee Stock Purchase Plan

  1,498,939   1,800,000 

Total

  28,922,321   29,635,697 

In June 2023, Vaxart completed an underwritten public offering in which 16,000,000 shares of its common stock were sold at an offering price of $0.8680 per share pursuant to the Company’s effective 2023 Shelf Registration. The net proceeds from the June 2023 Offering were $13.6 million after deducting underwriting discounts and commission and estimated offering expenses payable by Vaxart. The June 2023 Offering included a 30-day option to purchase up to an additional 2,400,000 common shares at the offering price of $0.8680 per share which expired in July 2023.

(c)

Warrants

The following warrants were outstanding as of September 30, 2023, 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

  16,175  $3.125 

March 2024

Common Stock

  10,914  $22.99 

December 2026

Total

  227,434      

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.

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.

A summary of stock option and RSU transactions in the nine months ended September 30,2023, 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, 2023

  12,074,692   14,725,261  $4.48   808,310  $3.57 

Granted

  (10,631,320)  7,399,849  $0.78   3,231,471  $0.78 

Exercised

     (54,720) $0.31     $ 

Released

       $   (163,766) $3.82 

Forfeited

  2,347,716   (2,066,399) $5.08   (281,317) $2.53 

Canceled

  1,736,253   (1,930,082) $4.48     $ 
                     

Balance as of September 30, 2023

  5,527,341   18,073,909  $2.91   3,594,698  $1.13 

As of September 30, 2023, there were 18,073,909 options outstanding with a weighted average exercise price of $2.91, a weighted average remaining term of 8.43 years and an aggregate intrinsic value of $52,000. Of these options, 6,434,571 were vested, with a weighted average exercise price of $4.08, a weighted average remaining term of 7.27 years and an aggregate intrinsic value of $44,000. 

The Company received $17,000 for the 54,720 options exercised during the nine months ended September 30,2023, which had an intrinsic value of $31,000 and received $214,000 for the 166,993 options exercised during the nine months ended September 30, 2022, which had an intrinsic value of $474,000. 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 September 30, 2023, based on the Company’s common stock closing price of $0.75 on September 29. 2023, 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 nine months ended September 30,2023 and 2022, was $0.78 and $3.88, respectively. Their fair values were estimated using the following assumptions:

Nine Months Ended September 30,

2023

2022

Risk-free interest rate

3.45% - 4.15%1.62% - 3.20%

Expected term (in years)

5.50 - 6.005.42 - 6.08

Expected volatility

128% - 134%125% - 131%

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 September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 
                 

Research and development

 $2,404  $2,567  $6,142  $6,977 

General and administrative

  1,439   1,076   4,275   3,217 

Total stock-based compensation

 $3,843  $3,643  $10,417  $10,194 

As of September 30, 2023, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $21.3 million, which the Company expects to recognize over an estimated weighted average period of 2.24 years.

13

VAXART, INC.

Notes to the Condensed Consolidated Financial Statements (Unaudited)

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 ESPP. The 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 nine months ended September 30,2023, the Company received $298,000 and issued 301,061 shares under the ESPP. As of September 30, 2023, 1,498,939 shares are available and reserved for future issuance under the ESPP.

The estimated fair value used for the six-month offering period beginning June 1, 2023 and ending November 30, 2023, was $0.54 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. Stock-based compensation expense related to the ESPP for the nine months ended September 30,2023, was $270,000. As of September 30,2023, the unrecognized stock-based compensation cost related to outstanding ESPP expected to be recognized is $61,000 by November 2023. The fair value of the ESPP shares was estimated using the Black-Scholes option pricing model using the following assumptions:

  

Six-Month Offering Period Ending November 30, 2023

  

Six-Month Offering Period Ending May 31, 2023

 
         

Risk-free interest rate

  5.37%  4.60%

Expected term (in years)

  0.5   0.5 

Expected volatility

  98.55%  84.66%

Dividend yield

  %  %

NOTE 11.  Net LossPer Share

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 September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 
                 

Net loss

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

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

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

Net loss per share – basic and diluted

 $(0.11) $(0.23) $(0.45) $(0.66)

No adjustment has been computed based onmade to the net loss in the threeand nine months ended September 30,2023, or 2022, as the weighted-average number of common shares outstanding during the applicable period. For diluted net loss per share, common stock equivalents (shares of common stock issuable upon the exercise of stock options and unvested restricted stock units) are excluded from the calculation as their inclusioneffect would be anti-dilutive. The Company has excluded all anti-dilutive share-based awardsdue to purchase common stock in periods indicating a loss, as their effect is anti-dilutive. 

the net loss.

 

The following tables set forthpotentially dilutive weighted average securities were excluded from the computation of historical basic and diluted net loss per share.weighted average shares outstanding because they would have been antidilutive:

 

  

Three Months Ended
December 31,

 
  

2017

  

2016

 
         

Net loss (in millions)

 $(3.4

)

 $(9.1

)

Weighted-average shares outstanding

  38,649,237   38,640,487 

Dilutive effect of restricted stock and stock options

  -   - 

Shares used to compute diluted earnings per share

  38,649,237   38,640,487 

Basic net loss per share

 $(0.09

)

 $(0.24

)

Diluted net loss per share

 $(0.09

)

 $(0.24

)

Number of anti-dilutive share-based awards excluded from computation

  6,898,629   5,645,543 

  

Six Months Ended
December 31,

 
  

2017

  

2016

 
         

Net loss (in millions)

 $(8.7

)

 $(19.1

)

Weighted-average shares outstanding

  38,649,237   38,640,487 

Dilutive effect of restricted stock and stock options

  -   - 

Shares used to compute diluted earnings per share

  38,649,237   38,640,487 

Basic net loss per share

 $(0.23

)

 $(0.49

)

Diluted net loss per share

 $(0.23

)

 $(0.49

)

Number of anti-dilutive share-based awards excluded from computation

  6,898,629   5,645,543 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 
                 

Options to purchase common stock

  18,151,747   14,735,710   17,019,217   13,170,959 
                 

Restricted stock units to purchase common stock

  3,629,741   660,660   2,840,178   353,738 
                 

Warrants to purchase common stock

  227,434   227,434   227,434   229,156 
                 

Employee Stock Purchase Plan

  337,496      379,720    
                 

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

  22,346,418   15,623,804   20,466,549   13,753,853 

 

 

(7)

Licenses, Royalty Collaborative and Contractual Arrangements

 

Royalty agreements

The Company entered into a royalty-bearing research and license agreement with GlaxoSmithKline (“GSK”) in 1990 for the development and commercialization of zanamivir, a neuraminidase inhibitor marketed by GSK as Relenza® to treat influenza. Under the terms of the agreement, the Company licensed zanamivir to GSK on an exclusive, worldwide basis. Most of the Company’s Relenza® patents have expired and the only substantial remaining intellectual property related to the Relenza® patent portfolio is scheduled to expire in July 2019 in Japan. Until that patent expires, the Company will receive a 7% royalty on GSK’s annual net sales of Relenza® in Japan.

The Company also generates royalty revenue from the sale of Inavir® (laninamivir octanoate or LANI) in Japan, pursuant to a collaboration and license agreement and a related commercialization agreement (collectively, the “Inavir® License Agreement”) with Daiichi Sankyo. Under the Inavir® License Agreement, the Company currently receives a 4% royalty on net sales of Inavir® in Japan and is eligible to earn sales milestone payments. Under the Inavir® License Agreement, the Company and Daiichi Sankyo have cross-licensed the world-wide rights to develop and commercialize the related intellectual property, and have agreed to share equally in any royalties, license fees, or milestone or other payments received from any third party licenses outside of Japan. The patent relating to hydrates and the crystalline form of LANI used in Inavir® expires in 2021 (not including extensions) in the U.S. and EU and in 2024 in Japan. In February 2015, a patent containing claims relevant to the manufacture of Inavir® was issued in Japan and expires in December 2029.

In April 2016, the Company entered into a Royalty Interest Acquisition Agreement (“Agreement”) with HCRP. Under the Agreement, HCRP made a $20 million cash payment to the Company in consideration for acquiring from the Company certain royalty rights (“Royalty Rights”) related to Inavir® in the Japanese market.

The following tables summarize the key components of the Company’s revenues (in millions):

  

Three Months Ended December 31,

 
  

2017

  

2016

 
  

(in millions)

 

Royalty revenue - Relenza®

 $-  $1.5 

Non-cash royalty revenue related to the sale of future royalties

  2.7   2.3 

Total revenue

 $2.7  $3.8 

  

Six Months Ended December 31,

 
  

2017

  

2016

 
  

(in millions)

 

Royalty revenue - Relenza®

 $-  $1.6 

Non-cash royalty revenue related to the sale of future royalties

  2.8   2.3 

Total revenue

 $2.8  $3.9 

Relenza revenue declined to zero in the three and six months ended December 31, 2017 from $1.5 million in the same periods of the prior fiscal year due to the cessation of royalties on U.S. sales at the end of 2016 and the unfavorable impact of a returns adjustment in the current quarter.

Collaborative and contract arrangements

In July 2016, the Company entered into an exclusive, worldwide license for RSV replication inhibitors intellectual property with Georgia State University Research Foundation (“GSURF”) in exchange for an upfront fee, future milestone payments and royalties on future net sales of any products that utilize the underlying RSV intellectual property. The Company has an obligation to make a minimum payment of $10,000 to GSURF annually until the license agreement expires or is terminated. The Company also entered into a two year sponsored research agreement with GSURF for annual sponsored research payments.

 

  

 

(8)

Income Taxes

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act significantly revises the future ongoing U.S. corporate income tax by, among other things, lowering U. S. corporate income tax rates and implementing a territorial tax system. Since the Company is a calendar year tax filer, the lower corporate income tax rate will be effective beginning January 1, 2018.

Based upon the provisions of the Tax Act, the Company’s deferred tax assets and liabilities will be remeasured to incorporate the lower corporate tax rate of 21% into its tax provision; however, since the Company maintains a full valuation allowance, there is no net impact to income tax expense reported in the Company’s financial statements for the periods presented as the provisional valuation allowance will be adjusted accordingly. At this time, the Company is still evaluating the impact of this remeasurement.

There are also certain transitional impacts of the Tax Act. As part of the transition to the new territorial tax system, the Tax Act imposes a one-time repatriation tax on deemed repatriation of historical earnings and profits (“E&P”) of foreign subsidiaries. Due to the complexity of this calculation and the information required to complete such a calculation, the Company is still reviewing its E&P from our foreign subsidiaries in connection with the one-time transition tax. 

The Company is also currently analyzing its global working capital and cash requirements and the potential tax liabilities attributable to a repatriation, including calculating any excess of the amount for financial reporting over the tax basis in its foreign subsidiaries, but has yet to determine whether it plans to change its prior assertion and repatriate earnings.  Accordingly, the Company has not recorded any deferred taxes attributable to its investments in its foreign subsidiaries. The Company will record the tax effects of any change in its prior assertion in the period that it completes its analysis and are able to make a reasonable estimate, and disclose any unrecognized deferred tax liability for temporary differences related to its foreign investments, if practicable.

The changes included in the Tax Act are broad and complex. The final transition impacts of the Tax Act may affect our financial statements and/or disclosures, possibly materially, due to, among other things, changes in interpretations of the Tax Act, any legislative action to address questions that arise because of the Tax Act, any changes in accounting standards for income taxes or related interpretations in response to the Tax Act. The Securities Exchange Commission has issued rules that would allow for a measurement period of up to one year after the enactment date of the Tax Act to finalize the recording of the related tax impacts.

ITEM 2:  Item 2.  ManagementManagement’ss Discussion and Analysis of Financial Condition and Results of Operations

FORWARD LOOKING STATEMENTS

 

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 15, 2023. This Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking statements involve knownwithin the meaning of Section 27A of the Securities Act of 1933, as amended, and unknown risks, uncertaintiesSection 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 other factors that may cause actual results, performance or achievementsassumptions and on information currently available to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.our management. In mostsome cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “goal,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “forecast,” “potential,” “likely” or “possible”, as well as the negative of such expressions,“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. These forward-looking statements include, without limitation, statements relating to:

our expectations as to when top-line safety and efficacy data for BTA074 (teslexivir)are expected;

our anticipationFactors that we will generally incur net losses from operations in the future due to our intention to continue to support the preclinical and clinical development of our product candidates;

our future financing requirements, the factors that may influence the timing and amount of those requirements and our ability to fund them;

the number of months that our current cash, cash equivalents, investments and anticipated future proceeds from existing royalty-bearing licenses will allow us to operate; and

the expected post-Merger share ownership split between Vaxart and Aviragen stockholders and anticipated timing of the closing of the Merger.

Various important factors could cause actual results, performance, events or achievementscontribute to materially differ fromthese differences include those expressed or implied by forward-looking statements, including the U.S. Fooddiscussed below and Drug Administration (“FDA”) or a similar regulatory body in another country, a data safety monitoring board, or an institutional review board delaying, limiting, suspending or terminating any of the Company’s clinical development programs at any time for a lack of safety, efficacy, tolerability, anti-viral activity, commercial viability, regulatory or manufacturing issues, or any other reason whatsoever; the Company's ability to secure, manage and retain qualified third-party clinical research, preclinical research, data management and contract manufacturing organizations upon which it relies to assist in the design, development, implementation and execution of the clinical and preclinical development of all its product candidates; and these third-party organizations fulfilling their contractual obligations on a timely and satisfactory basis; the safety or efficacy data from planned or ongoing future preclinical and clinical studies of any of its product candidates not supporting the clinical development of that product candidate; the successful enrollment of the requisite number of study participants on a timely basis; the Company’s ability to comply with applicable government regulations in various countries and regions in which we are conducting, or expect to conduct, clinical trials; the Company’s ability to retain and recruit sufficient staff, including key executive management and employees, to manage our business; the Company’s ability to maintain, protect or defend its proprietary rights from unauthorized use by others, or not infringe on the intellectual property rights of others; our ability to successfully manage our expenses, operating results and financial position in line with our plans and expectations; the condition of the financial equity and debt markets and our ability to raise sufficient funding in such markets; changes in the general economic business or competitive conditions in the industry or with respect to our product candidates; potential employee resignations on short notice; provisions in certificate of incorporation, bylaws and laws of Delaware containing provisions that could delay or discourage a change in control of the Company; the Company’s obtaining the requisite stockholder approval and other conditions to the Merger being satisfied; and other cautionary statements contained elsewhere in this Quarterly Report on Form10-Q and 10-Q. The forward-looking statements included in the Company’s Annualthis Quarterly Report on Form 10-K for the year ended June 30, 2017,10-Q are made only as filed with the U.S. Securities and Exchange Commission on September 1, 2017.

There may be events in the future that we are unable to predict accurately, or over which we have no control. You should completely read this Form 10-Q and the documents that we reference herein that have been filed or incorporated by reference as exhibits and with the understanding that our actual future results may be materially different from what we expect. Our business, financial condition, results of operations, and prospects may change. We may not update these forward-looking statements, even though our situation may change in the future, unless we have an obligation under the federal securities laws to update and disclose material developments related to previously disclosed information.We qualify all of the date hereof. These statements are based upon information presented in this Form 10-Q, and particularly our forward-looking statements, by these cautionary statements.

Aviragen is a registered trademark of Aviragen Therapeutics Inc., Relenza®is a registered trademark of GlaxoSmithKline plc, and Inavir®is a registered trademark of Daiichi Sankyo Company, Ltd.

Referencesavailable to “we,” “us,” and “our” refer to Aviragen Therapeutics, Inc. and its subsidiaries.

The following is a discussion and analysisus as of the major factors contributing to our results of operations for the three and six months ended December 31, 2017, and our financial condition at thatfiling date and should be read in conjunction with the financial statements and the notes thereto included inPart I,Item 1 of this Quarterly Report on Form 10-Q.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

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.

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 investigational vaccines are administered using a room temperature-stable tablet, rather than by injection. 

Our Product Pipeline

Figure1. The following table outlines the status of our oral vaccine development programs:

figure1.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, 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. In a study by the CDC and Johns Hopkins University, published in 2016, the global annual economic impact of norovirus disease was estimated at $60 billion, $34 billion of which occurred in high income regions including the United States. An update by the lead authors estimated the burden in the U.S. alone to be $10.5 billion annually in 2018. 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 are focusedcurrently conducting additional analyses of the data from our norovirus trials and will engage with regulators to discuss a Phase 2B study and potentially a GII.4 challenge study. We expect the Phase 2B study will generate sufficient safety data to enable us to have an end of Phase 2 meeting with the FDA, potentially as early as in the fourth quarter of 2024. The end of Phase 2 meeting will allow us to gain concurrence on the discoveryscope and developmentdesign of direct-acting antiviralsthe Phase 3 pivotal efficacy study in adults over 18 years of age.

In the Fall of 2022, we announced a study that would receive significant funding and support from the Bill and Melinda Gates Foundation to treat infectionsevaluate 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 have limited therapeutic optionsare induced in milk may protect breastfeeding infants from infectious pathogens. We initiated this study in the fourth quarter of 2023. As a grant recipient from the Bill and affectMelinda Gates Foundation, Vaxart has agreed to a significant numberglobal access commitment for use of patients globally. The Company has threeits bivalent norovirus vaccine candidate, if proven effective and approved, in breastfeeding mothers from low- and middle-income countries.

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 stage compounds: BTA074 (teslexivir),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 antiviral treatment for condyloma caused by human papillomavirus types 6 & 11; vapendavir, a capsid inhibitor for the preventionmRNA vaccine (either Pfizer/BioNTech or treatment of rhinovirus (“RV”) upper respiratory infections; and BTA585 (enzaplatovir)Moderna). Serum neutralizing antibody responses to SARS-CoV-2 (Wuhan), a fusion protein inhibitorrecognized correlate of protection, were boosted in development forthis 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 treatmentneutralizing 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 respiratory syncytial virus infections.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.

 

Although severalIn February 2021, we announced our Phase 1 study evaluating the safety and immunogenicity of our influenza product candidatesoral 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 been successfully developedalso initiated preclinical work on novel vaccine constructs that seek to create more a potent pan-betacoronavirus vaccine candidate that would respond to SARS-CoV-2 and commercializedalso other betacoronaviruses (such as SARS-CoV-1 and MERS-CoV).

The Company remains engaged in discussions with regulatory agencies, governments, non-governmental organizations and other potential strategic parties to date by other larger pharmaceutical companiesdetermine the best way to progress its pan-betacoronavirus vaccine program.

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. The total economic burden of seasonal influenza in the United States has been estimated to be $87.1 billion, including medical costs which average $10.4 billion annually, while lost earnings due to illness and loss of life amount to $16.3 billion annually.

In September 2018, we completed a $15.7 million contract with the U.S. Government through the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (“BARDA”) under license, collaboration or commercialization agreements with us, we have not independently developed or received regulatory approval for any product candidate, and we do not currently have any sales, marketing or commercial capabilities. Therefore, it is possible that we may not derive any significant product revenues from any product candidates that we are developing now, or may develop in the future. We expect to incur losses for the foreseeable future as we intend to support the clinical and preclinical developmentwhich a Phase 2 challenge study of our product candidates.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.

 

On October 30, 2017,2018, 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, which we have discontinued independent clinical development of. 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 December 2029. 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”). We pay HCRP the first $3 million plus 15% of the next $1 million of royalties earned in annual periods ending on March 31. At the time of the Merger, the estimated future benefit to HCRP was remeasured at fair value and was estimated to be $15.9 million, which we account for as a liability and amortize using the effective interest method over the remaining estimated life of the arrangement. The estimated future benefit was remeasured as of December 31, 2022, when the fair value was estimated to be $5.7 million, resulting in a revaluation gain of $7.0 million in the year ended December 31, 2022. Even though we do not retain the related royalties under the transaction, as the amounts are remitted to HCRP, we will continue to record revenue related to these royalties until the amount of the associated liability and related interest is fully amortized.

Grant Revenue

In November 2022, the Company announcedaccepted a grant (the “BMGF Grant”) to perform research and development work for the Bill & Melinda Gates Foundation (“BMGF”) and received $2.0 million in advance that it had entered into 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 has been executed and the Merger Agreement pursuant tocontract price is fixed or determinable. Revenue from the BMGF Grant is recognized in the period during which Vaxart,the related costs are incurred and the related services are rendered, provided that the applicable conditions under the contract have been met. Costs of contract revenue are recorded as a privately-held clinical-stage company focusedcomponent of operating expenses in the consolidated statements of operations and comprehensive loss. The Company recognized revenue from the BMGF Grant of $1.7 million in the three months ended September 30, 2023 and $3.4 million in the nine months ended September 30, 2023. As of September 30, 2023 and December 31, 2022, restricted cash and deferred revenue were $79,000 and $2.0 million, respectively.

Research and Development Expenses

Research and development expenses represent costs incurred on conducting research, such as developing oral recombinant vaccines from its proprietary deliveryour tablet vaccine platform, would become a wholly-owned subsidiaryand 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 Company. This transaction marksfollowing:

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 culminationmajority 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 September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

2023

  

2022

 

External program costs:

                

Norovirus program

 $1,648  $2,491  $9,065  $6,229 

COVID-19 program

  884   2,287   2,876   5,244 
       Other programs     52      171 

Preclinical research

  68   317   698   1,267 

Process development

  

103

   634   887   1,820 

Total external costs

  2,703   5,781   13,526   14,731 

Internal costs

  12,299   16,685   39,911   45,864 

Total research and development

 $15,002  $22,466  $53,437  $60,595 

We expect to incur significant research and development expenses in 2023 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 and nine months ended September 30, 2023 and 2022 (in thousands, except percentages):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

% Change

  

2023

  

2022

  

% Change

 
                         

Revenue

 $2,101  $   100% $4,134  $85   * 
                         

Operating expenses

  19,923   29,426   (32)%  70,581   83,534   (16)%
                         

Operating loss

  (17,822)  (29,426)  (39)%  (66,447)  (83,449)  (20)%
                         

Net non-operating income (expense)

  461   133   *   1,444   (340)  * 
                         

Loss before income taxes

  (17,361)  (29,293)  (41)%  (65,003)  (83,789)  (22)%
                         

Provision for income taxes

  39   16   *

 

  87   51   71%
                         

Net loss

 $(17,400) $(29,309)  (41)% $(65,090) $(83,840)  (22)%

* Percentages greater than 100% or not meaningful

Total Revenue 

The following table summarizes the period-over-period changes in our revenues for the three and nine months ended September 30, 2023 and 2022 (in thousands, except percentages):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

% Change

  

2023

  

2022

  

% Change

 

Non-cash royalty revenue related to sale of future royalties

 $446  $   100

%

 $754  $85   *

 

Grant revenue

  1,655      100

%

 $3,380  $   100%

Total revenue

 $2,101  $   100

%

 $4,134  $85   * 

* Percentages greater than 100% or not meaningful

Non-cash Royalty Revenue Related to Sale of Future Royalties

Non-cash royalty revenue related to sale of future royalties for the three months ended September 30, 2023 and 2022, was $0.4 million and nil, respectively, and for the nine months ended September 30, 2023 and 2022, was $0.8 million and $85,000, respectively. The increase was due to an increase in sales of Inavir in Japan. Non-cash royalty revenue of up to $3.3 million may be earned each year ending March 31. The Company’s royalty revenue is seasonal, in line with the flu season, so the majority of the Company’s Strategic Review process which was initiated in April. The Merger will result in a clinical-stage pharmaceutical company focused on developing Vaxart’s oral recombinant vaccinesroyalty revenue and our direct-acting antiviralsnon-cash royalty revenue related to treat infections that have limited therapeutic options. We believe Vaxart’s oral tablet vaccines have the potential to be major productssale of future royalties are earned in the worldwide vaccine market.first and fourth fiscal quarters.

Grant Revenue

 

The exchange ratioCompany recognized revenue from the Bill and Melinda Gates Foundation Grant of $1.7 million and $3.4 million in the merger agreement was determinedthree and nine months ended September 30, 2023, respectively. 

Total Operating Expenses

The following table summarizes the period-over-period changes in our operating expenses for the three and nine months ended September 30, 2023 and 2022 (in thousands, except percentages):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

% Change

  

2023

  

2022

  

% Change

 

Research and development

 $15,002  $22,466   (33

)%

 $53,437  $60,595   (12

)%

General and administrative

  4,921   6,960   (29

)%

  17,144   22,939   (25

)%

Total operating expenses

 $19,923  $29,426   (32

)%

 $70,581  $83,534   (16

)%

Research and Development

For the three months ended September 30,2023, research and development expenses decreased by Vaxart assigning $60,000,000 in value to Aviragen for its financial and clinical assets, and $90,000,000 in value for its own assets. On a pro forma basis after giving effect$7.5 million, or 33%, compared to the numberthree months ended September 30,2022. The decrease is primarily due to decreases in manufacturing costs, personnel related costs and clinical trial expenses related to our COVID-19 vaccine candidates, partially offset by increased depreciation.

For the nine months ended September 30, 2023, research and development expenses decreased by $7.2 million, or 12%, compared to the nine months ended September 30, 2022. The decrease is primarily due to decreases in manufacturing costs, personnel related costs and clinical trial expenses related to our COVID-19 vaccine candidates, partially offset by increased facilities and depreciation expense and increased clinical trial expenses related to our norovirus vaccine candidates.

General and Administrative

For the three months ended September 30, 2023, general and administrative expenses decreased by $2.0 million, or 29%, compared to the three months ended September 30, 2022. The decrease is primarily due to a decrease in legal and professional fees, directors' and officers' insurance and personnel related costs, partially offset by an increase in personnel stock-based costs.

For the nine months ended September 30, 2023, general and administrative expenses decreased by $5.8 million, or 25%, compared to the nine months ended September 30, 2022. The decrease is primarily due to a decrease in litigation settlement cost, legal and professional fees, directors' and officers' insurance and personnel related costs, partially offset by an increase in personnel stock-based costs.

Non-Operating Income (Expense)

The following table summarizes the period-over-period changes in our non-operating income for the three and nine months ended September 30, 2023 and 2022, respectively (in thousands, except percentages):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

% Change

  

2023

  

2022

  

% Change

 

Interest income

 $723  $458   58

%

 $2,076  $650   * 

Non-cash interest expense related to sale of future royalties

  (207)  (325)  36

%

  (573)  (988)  42

%

Other expense, net

  (55)     *   (59)  (2)  * 

Net non-operating income (expense)

 $461  $133   *  $1,444  $(340)  * 

* Percentages greater than 100% or not meaningful

For the three months ended September 30, 2023, we recorded interest income of $0.7 million, a 58% increase from the $0.5 million interest income recorded in the three months ended September 30, 2022. For the nine months ended September 30, 2023, we recorded interest income of $2.1 million, a 219% increase from the $0.7 million interest income recorded in the nine months ended September 30, 2022. The increase is due to an increase in interest rates on our cash, cash equivalents, restricted cash and marketable securities.

Non-cash interest expense related to sale of future royalties, which relates to accounting for sums that will become payable to HCRP for royalty revenue earned from Inavir as debt, was $0.2 million in the three months ended September 30, 2023, down from the $0.3 million in the three months ended September 30, 2022, and $0.6 million in the nine months ended September 30, 2023, down from the $1.0 million in the nine months ended September 30, 2022, as the outstanding balance due to HCRP has been paid down and remeasured. We project a further reduction in 2023 following the December 2022 revaluation of our liability to HCRP.

Provision for Income Taxes

The following table summarizes the period-over-period changes in our provision for income taxes for the three and nine months ended September 30, 2023 and 2022, respectively (in thousands, except percentages):

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2023

  

2022

  

% Change

  

2023

  

2022

  

% Change

 

Foreign withholding tax on royalty revenue

 $23  $   100% $38  $4   * 

Foreign taxes payable on intercompany interest

  16   16   

%

  46   45   2%

State income taxes

        %  3   2   50%

Provision for income taxes

 $39  $16   *  $87  $51   71%

* Percentages greater than 100% or not meaningful

The provision for income taxes was $39,000 and $16,000 in the three months ended September 30, 2023 and 2022, respectively, and $87,000 and $51,000 in the nine months ended September 30, 2023 and 2022, respectively. The tax charge relates primarily 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

Our primary source of financing is from the sale and issuance of common stock and common stock warrants in public offerings, along with proceeds from the exercise of warrants. In the past, we have also obtained funds from the issuance of secured debt and preferred stock and from collaboration agreements.

In June 2023, Vaxart completed an underwritten public offering (the “June 2023 Offering”) in which 16,000,000 shares of its common stock were sold at an offering price of $0.8680 per share. The net proceeds from the June 2023 Offering were $13.6 million after deducting underwriting discounts and commission and estimated offering expenses payable by Vaxart.

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 will 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.

As of AviragenSeptember 30, 2023, we had received net proceeds of $1.4 million from the sale of common stock under the September 2021 ATM and there is approximately $79.0 million in net proceeds still available to us. Since September 30, 2023, we have not raised any additional capital under the September 2021 ATM. 

As of September 30, 2023, we had approximately $53.0 million of cash, cash equivalents, restricted cash and marketable securities. Our expectation is that we will be issuedcontinue to Vaxart security holdersgenerate operating losses and negative operating cash flows in the Mergerfuture and assuming no adjustmentsthe need for cash balancesadditional funding to support our planned operations raise substantial doubt regarding our ability to continue as provideda going concern for ina period of one year after the Merger Agreement, current Vaxart security holders will own approximately 60% ofdate that the combined company and current Aviragen security holders will own approximately 40% of the combined company. The transaction has been approved by the boards of directors of both companies. The Merger is expected to close in February 2018, subject to the approval of the stockholders of each company as well as other customary conditions.

At the end of the quarter, a small group of dissident stockholders, who call themselves the Concerned Aviragen Shareholders (“CAS”) Group, launched a proxy contest against the proposed merger with Vaxart andfinancial statements are seeking an opportunity to nominate individuals for election to the Company’s Board at our upcoming Annual Meeting.  We continue to believe the proposed merger with Vaxart is the best possible strategic alternative, and together, Aviragen and Vaxart will have the potential to create meaningful value for stockholders.

CRITICAL ACCOUNTING POLICIES AND ESTIMATESissued.

 

Management’s Discussion intends on completing 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 Analysiscollaboration agreements which, while reducing our risks and extending our cash runway, will also reduce our share of Resultseventual 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 Nasdaq; 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):

  

Nine Months Ended September 30,

 
  

2023

  

2022

 
         

Net cash used in operating activities

 $(56,932) $(65,627)

Net cash provided by (used in) investing activities

  28,848   (36,216)

Net cash provided by financing activities

  15,309   8,866 
         

Net decrease in cash, cash equivalents and restricted cash

 $(12,775) $(92,977)

Net Cash Used in Operating Activities

We experienced negative cash flow from operating activities for the nine months ended September 30, 2023 and 2022, in the amounts of Operations discusses$56.9 million and $65.6 million, respectively. The cash used in operating activities in the nine months ended September 30, 2023, was due to cash used to fund a net loss of $65.1 million and a decrease in working capital of $8.4 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 $16.5 million. The cash used in operating activities in the nine months ended September 30, 2022, was due to cash used to fund a net loss of $83.8 million and a decrease in working capital of $3.3 million, further decreased 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 $14.9 million. 

Net Cash Provided by (Used in) Investing Activities

In the nine months ended September 30, 2023, we received $30.7 million from maturities of marketable securities, net of purchases, and used $1.9 million to purchase property and equipment, net of disposals. In the nine months ended September 30, 2022, we used $25.5 million to purchase marketable securities, net of maturities, $5.7 million to purchase property and equipment and $5.0 million to pay for right-of-use assets.

Net Cash Provided by Financing Activities

In the nine months ended September 30, 2023, we received net proceeds of $13.6 million from the sale of 16,000,000 shares of our financial results, which (exceptcommon stock, $1.4 million from the sale of common stock under the September 2021 ATM and $0.3 million from the issuance of common stock under the employee stock purchase plan. In the nine months ended September 30, 2022, we received $8.7 million from the sale of common stock under the September 2021 ATM and $0.2 million from the exercise of stock options and warrants.

Contractual Obligations and Commercial Commitments

We have the following contractual obligations and commercial commitments as of September 30, 2023 (in thousands):

Contractual Obligation

 

Total

  

< 1 Year

  

2 - 3 Years

  

4 - 5 Years

  

> 5 Years

 
                     

Long Term Debt, HCRP

 $10,021   1,342   2,435   3,867   2,377 

Operating Leases

  26,716   1,043   8,696   10,180   6,797 

Purchase Obligations

  4,792   4,792          

Total

 $41,529   7,177   11,131   14,047   9,174 

Long Term Debt, HCRP. Under an agreement executed in 2016, we are obligated to pay HCRP the first $3 million plus 15% of the next $1 million of royalty revenues that we earn for sales of Inavir in each year ending on March 31. See Note 6 to the extent describedCondensed 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 Notes thereto)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 September 30, 2023, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $21.3 million, which the Company expects to recognize over an estimated weighted average period of 2.24 years. See Note 10 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 presentedprepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”).in the United States. The preparation of these financial statements requires us to make estimates and assumptionsjudgments that affect the reported amounts of assets, and liabilities and the disclosure of contingent assetsexpenses. On an ongoing basis, we evaluate these estimates and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

judgments. We base our estimates and judgments on historical experience current economic and industry conditions, andon various other factorsassumptions that we believe to be reasonable under the circumstances. This formsThese 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 under different assumptions or conditions.estimates. We believe there have been no changes to our criticalthat the accounting policies that requirediscussed below are critical to understanding our historical and future performance, as these policies relate to the more significant judgmentareas 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 as discussed in detaildetermining the accrued balance in each reporting period. As actual costs become known, we adjust our 2017 annual 10-K filing:accrued estimates.

 

Use of estimates

Revenue recognition

Accrued expenses

Share-based compensation

 

ForIntangible 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 descriptionstraight-line basis over the estimated period of recentfuture royalties of 11.75 years and $1.8 million for the developed technology related to Relenza which was fully amortized as of December 31, 2022. 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 by an independent third party based on discounted cash flows of estimated future revenue streams, which are highly subjective. The fair value, as reassessed as of December 31, 2022, is being amortized on a straight-line basis over the remaining period of future royalties of 6.1 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 nine months ended September 30, 2023, a notional 10% decrease in expected term would have reduced the fair value and the related compensation expense by approximately 2%.

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 nine months ended September 30, 2023, a notional 10% decrease in expected volatility (from 128% to 115%) would have reduced the fair value and the related compensation expense by approximately 4%.

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 policies andstandards in the first nine months of 2023, none of which had a material impact on our financial statements, refer to Note 2 in the condensed consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Results

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 Operationsour 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 debt securities. We do not enter into investments for the Three months ended December 31, 2017trading or speculative purposes and December 31, 2016we hold no equity securities. We presently have no borrowings or lines of credit. 

Summary. For the three months ended December 31, 2017,Specifically, as of September 30, 2023, we reported a net losshad cash, cash equivalents, restricted cash and investments of $3.4approximately $53.0 million, as compared to a net losswhich consist of $9.1 million in the same periodbank deposits, money market funds, direct obligations of the prior fiscal year. BasicU.S. government or its agencies, commercial paper and diluted net loss per share was $0.09 for the three month period ended December 31, 2017, as compared to a basic and diluted net loss per share of $0.24 in the same period of 2016. The following commentary provides details underlying changes from last year in the major line itemscorporate bonds. All of our statementinvestments must satisfy high credit rating requirements at the time of operations:

Revenue. Revenue decreasedpurchase. 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 $2.7 million for the three month periods ended December 31, 2017, as compared to $3.8 million in the same period in 2016, mostlyrisk of loss due to a decrease in our Relenza royalties. Relenza revenue declined to zero in the three months ended December 31, 2017 from $1.5 million in the same period of the prior fiscal year due to the cessation of royalties on U.S. sales at the end of 2016 and the unfavorable impact of a returns adjustment in the current quarter. The following table summarizes the key components of our revenue for the three months ended December 31, 2017 and 2016:   

  

Three Months Ended December 31,

 
  

2017

  

2016

 
  

(in millions)

 

Royalty revenue - Relenza®

 $-  $1.5 

Non-cash royalty revenue related to the sale of future royalties

  2.7   2.3 

Total revenue

 $2.7  $3.8 

Research and Development Expense. Research and development expense decreased to $2.5 million for the three months ended December 31, 2017 from $10.2 million for the same period in 2016. The following table summarizes the components of our research and development expense for the three months ended December 31, 2017 and 2016.interest rate changes is not significant.

 

16
24

  

Three Months Ended December 31,

 
  

(in millions)

 
  

2017

  

2016

 
         

Direct preclinical, clinical and product development expenses

 $1.4  $9.0 

Salaries, severance and share-based compensation expenses

  1.1   1.1 

Depreciation and facility related expenses

  -   0.1 

Total research and development expense

 $2.5  $10.2 

 

Direct preclinical, clinical and product development expense decreased largely due to reduced clinical trial activity and manufacturing costs, as two of our three Phase 2 clinical trials came to a close at the end of the prior fiscal year. Salaries, severance and share-based compensation expenses did not change as compared to the same period in 2016, as decreases due to reductions in personnel in the last quarter of the prior fiscal year were offset by severance expense for employees terminated in the current quarter.Exchange Rate Sensitivity

 

General and Administrative Expense. General and administrative expense increased to $3.1 million forOur royalty revenue, which is calculated in U.S. dollars, is based on sales in Japanese yen, so a 1% increase in the three months ended December 31, 2017 from $2.1 million for the same period in 2016, largely due to legal and professional fees related to the proposed merger with Vaxart announced in October 2017 and severance due to a reduction in personnel. The following table summarizes the componentsstrength of our general and administrative expense for the three months ended December 31, 2017 and 2016. 

  

Three Months Ended December 31,

 
  

(in millions)

 
  

2017

  

2016

 
         

Salaries, benefits and share-based compensation expenses

 $1.2  $1.1 

Professional and legal fees expenses

  1.4   0.4 

Other expenses

  0.5   0.6 

Total general and administrative expense

 $3.1  $2.1 

Foreign Exchange Loss (Gain),net. The impact of foreign exchange changed from a loss of $0.1 million in December 31, 2016 to no gain or loss for three months ended December 31, 2017. The positive impact on foreign exchange on our statement of operations was due to fluctuations in foreign currency exchange rates versus the U.S. dollar largely relatedagainst the yen would lead to the British Pounda 1% reduction in royalty revenue. All our other revenue and Australian dollar. The vast majority of our cash holdings are held in the U.S. dollar. We re-measuresubstantially all of our foreignexpenses, assets and liabilities at the period-end exchange rateare denominated in U.S. dollars and, the net effect of these translation adjustments is shown as a result, we have not experienced significant foreign currency lossexchange gains or gain.

Results of Operations for the Six months ended December 31, 2017losses recently and December 31, 2016

Summary. For the six months ended December 31, 2017, we reported a net loss of $8.7 million, as compared to a net loss of $19.1 milliondo not anticipate that foreign exchange gains or losses will be significant in the same period of the prior fiscal year. Basic and diluted net loss per share was $0.23 for the six month period ended December 31, 2017, as compared to a basic and diluted net loss per share of $0.49 in the same period of 2016. The following commentary provides details underlying changes from last year in the major line items of our statement of operations:

Revenue. Revenue decreased to $2.8 million for the six month periods ended December 31, 2017, as compared to $3.9 million in the same period in 2016, mostly due to a decrease in our Relenza royalties. Relenza revenue declined to zero in the six months ended December 31, 2017 from $1.6 million in the same period of the prior fiscal year due to the cessation of royalties on U.S. sales at the end of 2016 and the unfavorable impact of a returns adjustment in the current year. The following table summarizes the key components of our revenue for the six months ended December 31, 2017 and 2016:   near future.

 

  

Six Months Ended December 31,

 
  

2017

  

2016

 
  

(in millions)

 

Royalty revenue - Relenza®

 $-  $1.6 

Non-cash royalty revenue related to the sale of future royalties

  2.8   2.3 

Total revenue

 $2.8  $3.9 

Research and Development Expense. Research and development expense decreased to $5.3 million for the six months ended December 31, 2017 from $17.8 million for the same period in 2016. The following table summarizes the components of our research and development expense for the six months ended December 31, 2017 and 2016.

  

Six Months Ended December 31,

 
  

(in millions)

 
  

2017

  

2016

 
         

Direct preclinical, clinical and product development expenses

 $3.3  $15.4 

Salaries, severance and share-based compensation expenses

  1.9   2.2 

Depreciation and facility related expenses

  0.1   0.2 

Total research and development expense

 $5.3  $17.8 

Direct preclinical, clinical and product development expense decreased largely due to reduced clinical trial activity and manufacturing costs, as two of our three Phase 2 clinical trials came to a close at the end of the prior fiscal year. Salaries, severance and share-based compensation expenses decreased compared to the same period in 2016 due to a reduction in personnel in the last quarter of the prior fiscal year, partially offset by severance expense for employees terminated in the current year.

General and Administrative Expense. General and administrative expense increased to $5.4 million for the six months ended December 31, 2017 from $4.3 million for the same period in 2016, largely due to legal and professional fees related to the proposed merger with Vaxart announced in October 2017 and severance due to a reduction in personnel. The following table summarizes the components of our general and administrative expense for the six months ended December 31, 2017 and 2016. 

  

Six Months Ended December 31,

 
  

(in millions)

 
  

2017

  

2016

 
         

Salaries, benefits and share-based compensation expenses

 $2.3  $2.0 

Professional and legal fees expenses

  2.0   1.1 

Other expenses

  1.1   1.2 

Total general and administrative expense

 $5.4  $4.3 

LIQUIDITY AND CAPITAL RESOURCES

For the six months ended December 31, 2017, cash and cash equivalents increased by $11.7 million. This increase was primarily the result of the maturities of our short-term investments.

Net cash used by operating activities was $9.2 million for the six months ended December 31, 2017, which reflected our net loss during the period of $8.7 million, a net decrease in a net operating assets of $0.5 million and a decrease in operating liabilities of $0.1 million, partially offset by net non-cash adjustments of $1.1 million. Non-cash adjustments consist of $2.7 million in non-cash royalty income, net of withholding taxes, partially offset by $0.8 million in non-cash interest expense and $0.8 million in share-based compensation expense.

Our net loss resulted largely from our funding of research and development activities including conducting the CT4 clinical trial for BTA074 (teslexivir), as well as ongoing general and administrative expenses including legal and professional fees related to the proposed merger with Vaxart. The net changes in operating assets and liabilities primarily reflects a $0.1 million decrease in accounts payable and accrued expense due to reduced clinical trial activity, offset by a $0.2 million decrease in prepaid expenses, also due to reduced clinical trial activity and a $0.3 million decrease in cash receivables primarily related to receipt of a research and development tax credit.

Net cash provided by investing activities during the six months ended December 31, 2017 consisted of the maturity of $27.9 million of investments, partially offset by the purchase of $7.0 million of investments.

At December 31, 2017, our cash and cash equivalents totaled $29.4 million. Our cash and cash equivalents are currently held in the form of short-term deposits with large U.S. banks, commercial paper and highly-rated corporate securities.

Based on our current strategy and operating plan, and considering the potential costs associated with advancing the preclinical and clinical development of our product candidates, we believe that our existing cash and cash equivalents of approximately $29.4 million as of December 31, 2017, along with the anticipated proceeds from existing royalty-bearing licenses will enable us to operate for a period of at least 12 months from the date of this report.

We have an ATM facility in place, which may allow us to quickly access the equity capital markets if we think it is prudent to do so and if market conditions allow. However, we currently do not have any commitments for future funding, nor do we anticipate that we will generate significant revenue, aside from revenue from existing royalty-bearing arrangements.

Contractual and Commercial Commitments

There have been no material changes from the information included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2017.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) (ii) of Regulation S-K under the Securities Exchange Act of 1934, as amended.

 

ITEM 3: Quantitative and Qualitative Disclosures about Market Risk

There has been no material change in our assessment of sensitivity to market risk since our presentation set forth in Item 7A “Quantitative and Qualitative Disclosures about Market Risk” in the our Annual Report on Form 10-K for the fiscal year ended June 30, 2017.

ITEM 4:4.  Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, includingwith the participation of our Chief Executive Officerprincipal executive officer and Chief Financial Officer,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 report.Quarterly Report on Form 10-Q. Based on thatsuch evaluation, our Chief Executive Officer and Chief Financial Officermanagement has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of the end of the period covered by this report.September 30, 2023.

 

Changes in Internal ControlsControl over Financial Reporting

 

There has beenwas no material change in our internal control over financial reporting that occurred during the quarter ended December 31, 2017September 30, 2023, 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

 

 

ITEMItem 1.  LEGAL PROCEEDINGSLegal Proceedings

 

The Companyinformation 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 various 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 incidentalneeded to the conduct of its business. The Company is not involved in any pending or threatened legal proceedings that it believesrun our business successfully, and could reasonably be expected to have a material adverse effectimpact on itsour business, financial condition orand results of operations.

 

ITEMItem 1A.  RISK FACTORSRisk Factors

 

Any investment in our business involves a high degree of risk. Before making an investment decision, youYou should carefully 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, 2022, which we filed with the Securities and Exchange Commission on March 15, 2023, together with all other information we includecontained or incorporated by reference in this Quarterly Report on Form 10-Q, includingwhen evaluating our condensed consolidated financial statementsbusiness and accompanying notes, andour prospects. There are no material changes to the additional informationrisk factors set forth in Part I, Item 1A, in our Annual Report on Form 10-K for the other reports we fileyear ended December 31, 2022. We have marked with the Securities and Exchange Commission along withan asterisk (*) those risks described below that reflect additions to the risks described in our Annual Report on Form 10-K for the fiscal year ended JuneDecember 31, 2022.

* 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 September 30, 20172023, we had $53.0 million of cash, cash equivalents, restricted cash, and investments. We believe these funds are sufficient to fund our operations into the third 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 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 financial statements.

* Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock.

Our common stock is listed on The Nasdaq Capital Market, which imposes, among other requirements, a $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). Our common stock traded for less than $1.00 for 30 consecutive trading days, and we received notice of this from the Listing Qualifications Department of The Nasdaq Stock Market on July 21, 2023. Under Nasdaq Listing Rule 5810(c)(3)(A), we were granted a 180-calendar day grace period, or until January 17, 2024, to regain compliance with the minimum bid price requirement. The minimum bid price requirement would be met if our common stock had a minimum closing bid price of at least $1.00 per share for a minimum of ten consecutive business days during the 180-calendar day grace period. If at any time during this 180-calendar day period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff stated that it will provide the Company is alsowith a written confirmation of compliance and the matter will be closed. However, under Nasdaq Listing Rule 5810(c)(3)(A), the Nasdaq staff may exercise its discretion to extend this ten-day period as discussed in Rule 5810(c)(3)(H).

Alternatively, if we fail to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180-calendar day period, we may be eligible for an additional 180-calendar day compliance period, provided (i) we meet the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the $1.00 minimum bid price requirement) and (ii) we provide written notice to Nasdaq of our intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event we do not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180-calendar day period, and if it appears to the Staff that we will not be able to cure the deficiency, or if we are not otherwise eligible, the Staff stated that it will provide us with written notification that our securities are subject to delisting from The Nasdaq Capital Market. At that time, we may appeal the risk factors set forth under the captions “Risks Relateddelisting determination to the Merger,” “Risks Relateda Hearings Panel. There can be no assurance that we will be able to Aviragen” and “Risks Relatedregain compliance or that Nasdaq will grant us a further extension of time to the Combined Company”regain compliance, if necessary.

The delisting of our common stock from Nasdaq may make it more difficult for us to raise capital on favorable terms in the Prospectusfuture, or at all. Such a delisting would likely have a negative effect on the price of our common stock and would impair our stockholders’ ability to sell or purchase our common stock when they wish to do so. Further, if our common stock were to be delisted from The Nasdaq Capital Market, our common stock would cease to be recognized as a covered security and we would be subject to additional regulation in each state in which we offer our securities. Moreover, there is no assurance that is part of the Registration Statement on Form S-4 (File No. 333-222009), as amended, filedany actions that we take to restore our compliance with the SecuritiesNasdaq minimum bid requirement would stabilize the market price or improve the liquidity of our common stock, prevent our common stock from falling below the Nasdaq minimum bid price required for continued listing again, or prevent future non-compliance with Nasdaq’s listing requirements.

There can be no assurance that we will continue to meet the minimum bid price requirement, or any other requirement in the future. If we fail to meet the minimum bid price requirement, or other applicable Nasdaq listing requirements, including maintaining minimum levels of stockholders’ equity or market values of our common stock, our common stock could be delisted. If our common stock were to be delisted, the liquidity of our common stock would be adversely affected, and Exchange Commission by the Company and declared effective on December 29, 2017. We have also described below those risks that reflect substantive changes from, or additions to, the risks described in our Annual Report on Form 10-K and Form S-4, as amended, referred to above. These risks may result in material harm to our business and our financial condition and results of operations. In this event, the market price of our common stock may decline and you could lose part or all of your investment.decrease.

 

We may* Unless our common stock continues to be listed on a national securities exchange it will become subject to the actions of activist shareholdersso-called penny stock. rules that impose restrictive sales practice requirements.

 

WeIf we are unable to maintain the listing of our common stock on Nasdaq or another national securities exchange, our common stock could become subject to the so-called “penny stock” rules if the shares have beena market value of less than $5.00 per share. The SEC has adopted regulations that define a penny stock to include any stock that has a market price of less than $5.00 per share, subject to certain exceptions, including an exception for stock traded on a national securities exchange. The SEC regulations impose restrictive sales practice requirements on broker-dealers who sell penny stocks to persons other than established customers and “accredited investors” as defined by relevant SEC rules. These additional requirements may discourage broker-dealers from effecting transactions in securities that are classified as penny stocks, which could severely limit the subjectmarket price and liquidity of increased activity by activist shareholders, including Digirad Corporation, East Hill Management Company, LLC, Thomas M. Clay, and certain other investors (collectively, the “Activist Group”). Responding to shareholder activism can be costly and time-consuming, disrupt our operations and divert the attention of management and our employees. Activist campaigns, including the Activist Group’s ongoing campaign against our proposed transaction with Vaxartsuch securities and the Activist Group’s noticeability of its intentionpurchasers to nominate a competing director slate for election at our annual stockholder meeting scheduled for April 11, 2018, can create uncertainties as to our future direction, strategy and leadership and may resultsell such securities in the losssecondary market. This means that if we are unable to maintain the listing of potential business opportunities and cause our common stock priceon a national securities exchange, the ability of stockholders to experience periods of volatility. Moreover, if individuals are elected to our board of directors with a specific agenda, our ability to effectively and timely implement our current initiatives, retain and attract experienced executives and employees and execute on our current business strategy maysell their common stock in the secondary market could be adversely affected.

If a transaction involving a penny stock is not exempt from the SEC’s rule, a broker-dealer must deliver a disclosure schedule relating to the penny stock market to each investor prior to a transaction. The broker-dealer also must disclose the commissions payable to both the broker-dealer and its registered representative, current quotations for the penny stock, and, if the broker-dealer is the sole market-maker, the broker-dealer must disclose this fact and the broker-dealer’s presumed control over the market. Finally, monthly statements must be sent disclosing recent price information for the penny stock held in the customer’s account and information on the limited market in penny stocks.

 

ITEMItem 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIESUnregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities

 

Not applicable.

 

ITEM 4. MINE SAFETY DISCLOSUREItem 3.  Defaults Upon Senior Securities

 

Not applicable.

 

ITEM 5. OTHER INFORMATIONItem 4.  Mine Safety Disclosures

 

None.Not applicable.

 

ITEM 6.  EXHIBITSItem 5.  Other Information

 

The exhibits to this report are listed in the Exhibit Index, which is incorporated into this Item 6 by reference.Not applicable.

  

Item 6.  Exhibits

 

 

Incorporated by Reference

Exhibit
Number

Description of Document

Schedule/Form

File
Number

Exhibit

Filing Date

      
3.1Restated Certificate of Incorporation of Aviragen Therapeutics, Inc.Form 10-K001-352853.1September 13, 2016
      
3.2Certificate of Amendment to Restated Certificate of Incorporation of Aviragen Therapeutics, Inc.Form 8-K001-352853.1February 20, 2018
      
3.3Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc.Form 8-K001-352853.2February 20, 2018
      
3.4Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc.Form 8-K001-352853.1April 24, 2019
      
3.5Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc.Form 8-K001-352853.1June 9, 2020
      
3.6Certificate of Amendment to Restated Certificate of Incorporation of Vaxart, Inc.Form 10-Q001-352853.3August 8, 2022
      
3.7Amended and Restated Bylaws of Vaxart, Inc., effective as of October 18, 2023Form 8-K001-352853.1October 23, 2023
      

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    
      
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)    

*Filed herewith.

§

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.

 

Aviragen Therapeutics, Inc.

Date: February 6, 2018

By:

/s/ Joseph M. Patti

Joseph M. Patti

Chief Executive Officer

(Principal Executive Officer)

By:

/s/ Mark P. Colonnese   

Mark P. Colonnese

Executive Vice President and Chief Financial Officer

(Principal Financial Officer) 

EXHIBIT INDEX

 

VAXART, INC.

Filed 

Incorporation by Reference

Exhibit

Number

Exhibit Title

with 

this

Form 

10-Q

Form

File No.

Date Filed

    
Dated: November 2, 2023By:  /s/ ANDREI FLOROIU
  Andrei Floroiu

President and Chief Executive Officer
(Principal Executive Officer)
    

2.1Dated: November 2, 2023

 

Agreement and Plan of Merger and Reorganization, dated October 27, 2017, by and among Aviragen Therapeutics, Inc., Vaxart, Inc. and Agora Merger Sub, Inc.By:  /s/ PHILLIP LEE

 

8-K

001-35285

171160761

10-30-2017

  

2.2Phillip Lee

 

Form of Support Agreement, by and between Aviragen Therapeutics, Inc., Agora Merger Sub, Inc., Vaxart, Inc. and certain of Vaxart, Inc.’s directors, officers and stockholders.

8-K

001-35285

171160761

10-30-2017

  

2.3Chief Financial Officer

 

Form of Support Agreement, by and between Aviragen Therapeutics, Inc., Agora Merger Sub, Inc., Vaxart, Inc. and Aviragen Therapeutics, Inc.’s directors and officers.

8-K

001-35285

171160761

10-30-2017

  

(Principal Financial and Accounting Officer)

  

 

31.1*

Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended

X

31.2*

Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended

 X

32.1*

Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350

X

101

The following financial information from the Aviragen Therapeutics, Inc. Quarterly Report on Form 10-Q for the period ended December 31, 2017 formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Operations for the Three months, (iii) the Condensed Statements of Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows, and (v) Notes to Condensed Consolidated Financial Statements

X

 

*      This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of Aviragen Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.

23

29