Vaxart Inc
For the period ended Mar 31, 2024. Filed May 13, 2024.
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Mar 31, 2024 · Filed May 13, 2024
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Notes to the Condensed Consolidated Financial Statements
VAXART****, INC.**
NOTE1. Organization and Nature of Business
General
Vaxart Biosciences, Inc. was originally incorporated in California in* March2004,* under the name West Coast Biologicals, Inc. The Company changed its name to Vaxart, Inc. (“Private Vaxart”) in* July2007,* and reincorporated in the state of Delaware. In* February 2018,*Private Vaxart completed a business combination with Aviragen Therapeutics, Inc. (“Aviragen”), pursuant to which Aviragen merged with Private Vaxart, with Private Vaxart surviving as a wholly-owned subsidiary of Aviragen (the “Merger”). Pursuant to the terms of the Merger, Aviragen changed its name to Vaxart, Inc. (together with its subsidiaries, the “Company” or “Vaxart”) and Private Vaxart changed its name to Vaxart Biosciences, Inc.
In* January**2024,* the Company entered into a securities purchase agreement (the*“2024* Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of the Company's common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share pursuant to the Company’s shelf registration statement on Form S-3 (FileNo. 333-270671) (the*“2023* Shelf Registration”). The gross proceeds from the2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.
On* September 15, 2021,the Company entered into a Controlled Equity Offering Sales Agreement (the “September 2021ATM”), pursuant to which it mayoffer and sell, from time to time through sales agents, shares of its common stock having an aggregate offering price of up to $100 million. The Company filed a prospectus supplement with the SEC on September 16, 2021,a subsequent prospectus supplement with the SEC on May 9, 2023and will pay sales commissions of up to 3.0% of gross proceeds from the sale of shares. In thethree* months ended* March 31, 2024,7,404,672 shares were issued and sold under the September 2021*ATM for gross proceeds of $8.7 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $8.4 million.
The Company’s principal operations are based in South San Francisco, California, and it operates inone reportable segment, which is the discovery and development of oral recombinant protein vaccines, based on its proprietary oral vaccine platform.
NOTE2. Summary of Significant Accounting Policies
Basis of Presentation, Liquidity and Going Concern – The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the accounting and disclosure rules and regulations of the SEC assuming the Company will continue as a going concern.
The Company is a clinical-stage biotechnology company withno product sales. Its primary source of capital is from the sale and issuance of common stock and common stock warrants. As of* March 31, 2024,the Company had cash, cash equivalents and investments of $36.7 million. The Company’s cash, cash equivalents and investments arenot* sufficient to fund the Company’s planned operations for a period of12 months from the date the financial statements are issued. The Company will be dependent upon raising additional capital through placement of its common stock, notes or other securities, borrowings, or entering into a partnership with a strategic party in order to implement its business plan.
Based on management's current plan, the Company expects to have enough cash runway into latefourth quarter of2024. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, management’s plans include further reducing or delaying operating expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period ofone year from the date of the issuance of these condensed consolidated financial statements. The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements donot include any adjustments that might be necessary if the Company is unable to continue as a going concern.
The condensed consolidated balance sheet as of* December 31, 2023,included in this filing, was derived from audited financial statements, but doesnot* include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in consolidated financial statements have been condensed or omitted pursuant to these rules and regulations. These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended* December**31,* 2023, included in the Company’s Annual Report on Form10-K filed with the SEC on* March 14, 2024* (the “Annual Report”). Unless noted below, there have beenno material changes to the Company’s significant accounting policies described in Note2 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 arenot necessarily indicative of the results to be expected for the full year or any future periods.
Basis of Consolidation – The unaudited condensed consolidated financial statements include the financial statements of Vaxart, Inc. and its subsidiaries. All significant transactions and balances between Vaxart, Inc. and its subsidiaries have been eliminated in consolidation.
Use of Estimates – The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities in the financial statements and accompanying notes. Actual results and outcomes could differ from these estimates and assumptions.
Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk consist principally of cash, cash equivalents, available-for-sale investments and accounts receivable. The Company places its cash, cash equivalents and available-for-sale investments at financial institutions that management believes are of high credit quality. The Company is exposed to credit risk in the event of default by the financial institutions holding the cash and cash equivalents to the extent such amounts are in excess of the federally insured limits. Losses incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.
The primary focus of the Company’s investment strategy is to preserve capital and meet liquidity requirements. The Company’s investment policy addresses the level of credit exposure by limiting the concentration in anyone corporate issuer or sector and establishing a minimum allowable credit rating.
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Recent Accounting Pronouncements
The Company has reviewed all significant newly-issued accounting pronouncements that arenot yet effective and concluded that they are eithernot applicable to its operations or their adoption isnot expected to have a material impact on its financial position or results of operations.
NOTE3**.Fair Value of Financial Instruments **
Fair value accounting is applied for all financial assets and liabilities and nonfinancial assets and liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis (at least annually). Financial instruments include cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued liabilities that approximate fair value due to their relatively short maturities.
Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets are categorized based upon the level of judgment associated with inputs used to measure their fair values. The accounting guidance for fair value provides a framework for measuring fair value and requires certain disclosures about how fair value is determined. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance also establishes athree-level valuation hierarchy that prioritizes the inputs to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity.
Thethree-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:
Level1 – Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;
Level2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that arenot active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and
Level3 – Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little orno market data.
The following table sets forth the fair value of the Company’s financial assets that are measured on a recurring basis as of* March 31, 2024* and* December 31, 2023* (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets: | ||||
| Money market funds | $17,710 | $— | $— | $17,710 |
| U.S. Treasury securities | — | 14,876 | — | 14,876 |
| Total assets | $17,710 | $14,876 | $— | $32,586 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Financial assets: | ||||
| Money market funds | $31,403 | $— | $— | $31,403 |
| U.S. Treasury securities | — | 4,958 | — | 4,958 |
| Total assets | $31,403 | $4,958 | $— | $36,361 |
The Company heldno financial liabilities measured on a recurring basis as of* March 31, 2024* or* December 31, 2023*.
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NOTE4**.**Balance Sheet Components
| (a) | Cash, Cash Equivalents and Investments |
Cash, cash equivalents and investments consisted of the following (in thousands):
| Amortized · Gross Unrealized · Estimated · Cash and · Short-Term | ||||||
|---|---|---|---|---|---|---|
| Cost | Gains | Losses | Fair Value | Cash Equivalents | Investments | |
| Cash at banks | $4,078 | $— | $— | $4,078 | $4,078 | $— |
| Money market funds | 17,710 | — | — | 17,710 | 17,710 | — |
| U.S. Treasury securities | 14,886 | — | (10) | 14,876 | 4,947 | 9,929 |
| Total | $36,674 | $— | $(10) | $36,664 | $26,735 | $9,929 |
| Amortized · Gross Unrealized · Estimated · Cash and · Short-Term | ||||||
|---|---|---|---|---|---|---|
| Cost | Gains | Losses | Fair Value | Cash Equivalents | Investments | |
| Cash at banks | $3,352 | $— | $— | $3,352 | $3,352 | — |
| Money market funds | 31,403 | — | — | 31,403 | 31,403 | — |
| U.S. Treasury securities | 4,959 | — | (1) | 4,958 | — | 4,958 |
| Total | $39,714 | $— | $(1) | $39,713 | $34,755 | $4,958 |
As of* March**31,2024* and* December 31, 2023,all investments were available-for-sale debt securities with remaining maturities of12* months or less.
| (b) | Accounts Receivable |
Accounts receivable comprises royalties receivable of $0.6 million and $3.0 million as of* March 31, 2024and December 31, 2023,respectively. The Company has providedno allowance for credit losses as of March 31, 2024and December 31, 2023,*based on past events and subsequent receipts.
| (c) | Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consists of the following (in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Prepaid clinical and manufacturing expenses | $1,762 | $984 |
| Unbilled revenue from government contracts | 1,596 | — |
| Prepaid insurance | 933 | 258 |
| Prepaid rent | 528 | 488 |
| Interest receivable | 140 | 127 |
| Other | 2,105 | 958 |
| Prepaid expenses and other current assets | $7,064 | $2,815 |
| (d) | Property and Equipment, Net |
Property and equipment, net consists of the following (in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Laboratory equipment | $13,507 | $13,448 |
| Office and computer equipment | 1,105 | 1,105 |
| Leasehold improvements | 3,998 | 3,985 |
| Construction in progress | 226 | 24 |
| Total property and equipment | 18,836 | 18,562 |
| Less: accumulated depreciation | (7,734) | (6,831) |
| Property and equipment, net | $11,102 | $11,731 |
Depreciation expense was $0.9 million for thethree months ended* March 31,* 2024 and2023. There wereno impairments of the Company’s property and equipment recorded in thethree months ended* March 31,* 2024 or2023.
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| (e) | Right-of-Use Assets, Net |
Right-of-use assets, net comprises facilities of $23.8 million and $24.8 million as of* March 31, 2024* and* December 31, 2023*, respectively. The right-of-use of additional leased premises in California commenced in2023, resulting in an additional $3.1 million right-of-use assets recorded in the year ended* December 31, 2023.*
| (f) | Intangible Assets, Net |
Intangible assets comprise developed technology and intellectual property. Intangible assets are carried at cost less accumulated amortization. As of* March 31, 2024*, developed technology and intellectual property had remaining lives of 5.6 and 3.75 years, respectively. As of* March 31, 2024,there have beenno* indicators of impairment. Intangible assets consist of the following (in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Developed technology | $5,000 | $5,000 |
| Intellectual property | 80 | 80 |
| Total cost | 5,080 | 5,080 |
| Less: accumulated amortization | (974) | (791) |
| Intangible assets, net | $4,106 | $4,289 |
Intangible asset amortization expense was $0.2 million for thethree months ended* March 31, 2024and2023.*
As of* March 31, 2024*, the estimated future amortization expense by year is as follows (in thousands):
| Year Ending December 31, | Amount |
|---|---|
| 2024 (nine months remaining) | $548 |
| 2025 | 732 |
| 2026 | 731 |
| 2027 | 731 |
| 2028 | 727 |
| Thereafter | 637 |
| Total | $4,106 |
| (g) | Goodwill |
Goodwill, which represents the excess of the purchase price over the fair value of assets acquired, comprises$4.5 million as of* March 31, 2024* and* December 31, 2023*. As of* March 31, 2024*, there have beenno indicators of impairment.
| (h) | Other Accrued Current Liabilities |
Other accrued current liabilities consist of the following (in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Accrued compensation | $3,199 | $4,576 |
| Accrued clinical and manufacturing expenses | 180 | 312 |
| Accrued professional and consulting services | 707 | 211 |
| Other liabilities, current portion | 894 | 535 |
| Total | $4,980 | $5,634 |
NOTE5**.**Revenue
Royalty Revenue Related to Sale of Future Royalties
The Company generates royalty revenue from the sale of Inavir in Japan, pursuant to a collaboration and license agreement that Aviragen entered into with Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) in2009. In* September 2010,laninamivir octanoate was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children, which Daiichi Sankyo markets as Inavir. Under the agreement, the Company currently receives a 4% royalty on net sales of Inavir in Japan. Based on information provided by Daiichi Sankyo, the Company believes the expiration of the last patent related to Inavir is in August 2036,at which time royalty revenue will cease. The Company’s royalty revenue is seasonal, in line with the flu season, so the majority of the Company’s royalty revenue and non-cash royalty revenue related to the sale of future royalties are earned in thefirst* andfourth fiscal quarters. The royalty revenue related to Inavir recognized for thethree months ended* March 31,* 2024 and2023, waszero. The Company recognized non-cash royalty revenue related to sale of future royalties of $0.6 million and $0.3 million for thethree months ended* March 31,* 2024 and2023, respectively (see Note6). Both royalty revenue and the non-cash royalty revenue related to the sale of future royalties are subject to a 5% withholding tax in Japan, for which $29,000 and $14,000 was included in income tax expense for thethree months ended* March 31,* 2024 and2023, respectively.
On* January 12, 2024,the Company was awarded a contract (the“2024* ASPR-BARDA Contract”) by the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Administration for Strategic Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services with a base and all options value of $9.3 million. Under the2024 ASPR-BARDA Contract, the Company received an award to support clinical trial planning activities for a Phase2b clinical trial that would compare the Company’s XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. The Company accounts for the2024 ASPR-BARDA Contract under Accounting Standards Codification958-605 and recognizes revenue as donor-imposed conditions are met. The Company recognized revenue from government contracts of $1.6 million for thethree months ended* March 31, 2024,based on the achievement of certain milestones under the2024* ASPR-BARDA Contract. Unbilled revenue from government contracts was $1.6 million as of* March 31, 2024.*
In* November 2022,the Company accepted a $3.5 million grant to perform research and development work for the Bill & Melinda Gates Foundation (the “BMGF Grant”) and received $2.0 million in advance that was recorded as restricted cash and deferred revenue. The Company received an additional $1.5 million in July 2023upon completion of certain milestones. The Company recognizes revenue under research contracts only when a contract is executed and the contract price is fixed or determinable. Revenue from the BMGF Grant was recognized in the period during which the related costs were incurred and the related services rendered, as the applicable conditions under the contract were met. Costs of contract revenue were recorded as a component of operating expenses in the consolidated statements of operations and comprehensive loss. The Company recognized revenue from the BMGF Grant ofzero and $0.4 million for thethree* months ended* March 31, 2024and2023,* respectively. The Company fully recognized revenue from the BMGF Grant during the year ended* December 31, 2023.*
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