Vaxart(VXRT) - 2022 Q1 - Quarterly Report

Part I. Financial Information This section presents Vaxart, Inc.'s unaudited financial statements and management's analysis of financial condition and operations for the quarter ended March 31, 2022 Item 1. Financial Statements (Unaudited) This section presents Vaxart, Inc.'s unaudited condensed consolidated financial statements and comprehensive notes for the quarter ended March 31, 2022 Condensed Consolidated Balance Sheets The company's total assets decreased from $221.17 million at December 31, 2021, to $200.38 million at March 31, 2022, primarily driven by a reduction in cash and cash equivalents, while total liabilities remained relatively stable and total stockholders' equity decreased Financial Highlights (in thousands) | Metric (in thousands) | Dec 31, 2021 | Mar 31, 2022 | Change | | :-------------------- | :----------- | :----------- | :----- | | Total Assets | $221,168 | $200,378 | (9.4%) | | Cash and cash equivalents | $143,745 | $123,404 | (14.2%) | | Total Liabilities | $33,637 | $34,013 | 1.1% | | Total Stockholders' Equity | $187,531 | $166,365 | (11.3%) | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended March 31, 2022, Vaxart reported a net loss of $25.10 million, a significant increase from $16.01 million in the prior-year period, driven by an 81% rise in R&D expenses and an 83% decrease in total revenue Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric (in thousands) | 3 Months Ended Mar 31, 2022 | 3 Months Ended Mar 31, 2021 | % Change | | :-------------------- | :-------------------------- | :-------------------------- | :------- | | Total Revenue | $85 | $506 | (83)% | | Research and development | $18,203 | $10,073 | 81% | | General and administrative | $6,658 | $5,944 | 12% | | Operating Loss | $(24,776) | $(15,511) | 60% | | Net Loss | $(25,101) | $(16,007) | 57% | | Net Loss Per Share (basic & diluted) | $(0.20) | $(0.14) | 42.9% | Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity decreased by $21.17 million during the three months ended March 31, 2022, primarily due to a net loss of $25.10 million and unrealized losses on investments, partially offset by common stock issuance and stock-based compensation Stockholders' Equity Changes (in thousands) | Metric (in thousands) | Dec 31, 2021 | Mar 31, 2022 | Change | | :-------------------- | :----------- | :----------- | :----- | | Total Stockholders' Equity | $187,531 | $166,365 | $(21,166) | | Net Loss | | $(25,101) | | | Issuance of common stock (ATM) | | $992 | | | Stock-based compensation | | $3,130 | | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $25.11 million in Q1 2022, while investing activities provided $3.73 million and financing activities provided $1.04 million, reflecting shifts in investment and funding sources Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | 3 Months Ended Mar 31, 2022 | 3 Months Ended Mar 31, 2021 | % Change | | :-------------------- | :-------------------------- | :-------------------------- | :------- | | Net cash used in operating activities | $(25,113) | $(16,592) | 51.4% |\n| Net cash provided by (used in) investing activities | $3,732 | $(20,559) | N/A | | Net cash provided by financing activities | $1,040 | $67,592 | (98.5)% | | Net (decrease) increase in cash and cash equivalents | $(20,341) | $30,441 | N/A | | Cash and cash equivalents at end of period | $123,404 | $157,311 | (21.6)% | Notes to the Condensed Consolidated Financial Statements These notes provide detailed information supporting the condensed consolidated financial statements, covering the company's organization, accounting policies, balance sheet components, revenue, liabilities, leases, commitments, equity, net loss per share, and subsequent events NOTE 1. Organization and Basis of Presentation Vaxart, Inc., reincorporated in Delaware in 2007, operates in one segment focused on oral recombinant protein vaccines and utilized an "at-the-market" offering in Q1 2022 - Vaxart, Inc. is a Delaware-incorporated company, formed through a business combination in 2018[21] - The company operates in one reportable segment: discovery and development of oral recombinant protein vaccines[25] - In Q1 2022, 216,000 shares were sold under the September 2021 ATM for net proceeds of $1.0 million[24] NOTE 2. Summary of Significant Accounting Policies This note outlines the basis of presentation for the unaudited condensed consolidated financial statements, prepared in accordance with SEC rules and U.S. GAAP, with no material changes to significant accounting policies - Financial statements are prepared in accordance with SEC rules and U.S. GAAP, with certain information condensed or omitted[26] - The statements include Vaxart, Inc. and its subsidiaries, with all significant intercompany transactions and balances eliminated[27] - Management makes estimates and assumptions that affect reported amounts, and actual results could differ[28] - The company's investment strategy focuses on preserving capital and meeting liquidity requirements, with credit exposure limited by concentration and minimum credit rating[32] NOTE 3. Fair Value of Financial Instruments The company applies fair value accounting for financial assets and liabilities, categorizing $109.70 million in recurring financial assets into a three-level hierarchy, primarily in money market funds and U.S. Treasury securities - Fair value accounting is applied for financial assets and liabilities, categorized into a three-level valuation hierarchy based on input observability[34][35] Recurring Financial Assets Measured at Fair Value (in thousands) | Asset Type | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :------------------ | :---------------------------- | :------------------------------- | | Money market funds | $76,094 | $70,978 | | U.S. Treasury securities | $20,319 | $24,997 | | Commercial paper | $6,882 | $7,491 | | Corporate debt securities | $6,402 | $6,464 | | Total | $109,697 | $109,930 | NOTE 4. Balance Sheet Components This note details key balance sheet accounts, showing cash, cash equivalents, and investments decreased to $157.01 million, while property and equipment increased and intangible assets decreased due to amortization Cash, Cash Equivalents, and Marketable Securities (in thousands) | Category | March 31, 2022 (in thousands) | December 31, 2021 (in thousands) | | :------------------ | :---------------------------- | :------------------------------- | | Cash at banks | $47,310 | $72,767 | | Money market funds | $76,094 | $70,978 | | U.S. Treasury securities | $20,319 | $24,997 | | Commercial paper | $6,882 | $7,491 | | Corporate debt securities | $6,402 | $6,464 | | Total Fair Value | $157,007 | $182,697 | - Property and equipment, net, increased to $7.63 million as of March 31, 2022, from $6.60 million at December 31, 2021, with depreciation expense of $370,000 in Q1 2022[41] - Intangible assets, net, decreased to $10.29 million as of March 31, 2022, from $10.62 million at December 31, 2021, with amortization expense of $338,000 in Q1 2022[45] - Goodwill remained stable at $4.51 million as of March 31, 2022, with no indicators of impairment[46] NOTE 5. Revenue The company generates royalty revenue from Inavir sales in Japan, with non-cash royalty revenue decreasing by 83% to $85,000 in Q1 2022 due to reduced sales, and revenue being seasonal - Royalty revenue is generated from the sale of Inavir in Japan, with a 4% royalty on net sales until December 2029[48] - Non-cash royalty revenue related to sale of future royalties decreased by 83% to $85,000 in Q1 2022 from $493,000 in Q1 2021, due to reduced Inavir sales[48] - Royalty revenue is seasonal, with the majority earned in the first and fourth fiscal quarters[49] NOTE 6. Liabilities Related to Sale of Future Royalties In 2016, Aviragen sold Inavir royalty rights to HCRP for $20.0 million, accounted for as a liability amortized using the interest method, with the balance at $11.79 million as of March 31, 2022 - Royalty rights related to Inavir in the Japanese market were sold to HCRP for $20.0 million in 2016, accounted for as a liability amortized using the interest method[52][53] - HCRP is entitled to the first $3.0 million plus 15% of the next $1.0 million in royalties earned annually[52] Future Royalties Liability (in thousands) | Metric | Amount (in thousands) | | :---------------------------------------- | :-------------------- | | Total liability, start of period (Dec 31, 2021) | $11,522 | | Non-cash royalty revenue paid to HCRP | $(71) | | Non-cash interest expense recognized | $340 | | Total liability, end of period (Mar 31, 2022) | $11,791 | | Current portion | $(836) | | Long-term portion | $10,955 | NOTE 7. Leases The company has operating lease agreements for facilities with a weighted average remaining term of 6.67 years, total undiscounted obligations exceeding $17.9 million, and a Q1 2022 lease cost of $1.10 million - As of March 31, 2022, the weighted average discount rate for operating leases was 9.27% and the weighted average remaining term was 6.67 years[60] Operating Lease Obligations (in thousands) | Year Ending December 31, | Amount (in thousands) | | :----------------------- | :-------------------- | | 2022 (nine months remaining) | $1,590 | | 2023 | $2,168 | | 2024 | $2,242 | | 2025 | $2,316 | | 2026 | $2,852 | | Thereafter | $6,770 | | Undiscounted total | $17,938 | | Less: imputed interest | $(5,022) | | Present value | $12,916 | - Total lease cost for the three months ended March 31, 2022, was $1.10 million, up from $0.98 million in the prior year[62] NOTE 8. Commitments and Contingencies As of March 31, 2022, Vaxart had $20.7 million in non-cancelable purchase commitments and is involved in legal proceedings, though management does not believe any loss is probable or estimable - As of March 31, 2022, the Company had approximately $20.7 million of non-cancelable purchase commitments, principally for contract manufacturing and clinical services[67] - The company is a nominal defendant in several shareholder derivative and securities class actions challenging stock options, proxy statements, and warrant amendments[70][71][75] - Management does not presently believe that any loss from ongoing litigation is probable and it is not possible to reasonably estimate the loss[79] NOTE 9. Stockholders' Equity The company is authorized to issue 150 million common shares, with 125.84 million outstanding as of March 31, 2022, and 16.00 million shares reserved for equity awards and warrants - Authorized common stock: 150,000,000 shares; outstanding: 125,840,811 shares as of March 31, 2022[9] - No dividends had been declared by the board of directors as of March 31, 2022[83] Equity Awards and Warrants Reserved | Category | March 31, 2022 | December 31, 2021 | | :---------------------------- | :------------- | :---------------- | | Options issued and outstanding | 13,253,647 | 10,216,106 | | RSUs issued and outstanding | 245,625 | — | | Available for future grants | 2,269,093 | 5,582,742 | | Common stock warrants | 232,434 | 232,434 | | Total | 16,000,799 | 16,031,282 | NOTE 10. Equity Incentive Plans The 2019 Equity Incentive Plan's share reserve was increased to 16.90 million shares, with 245,625 restricted stock units granted and $3.13 million in stock-based compensation recognized in Q1 2022 - The 2019 Equity Incentive Plan's aggregate share reserve was increased to 16,900,000 shares in June 2021[90] - In March 2022, the Company granted 245,625 restricted stock unit (RSU) awards to employees[91] Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended Mar 31, 2022 (in thousands) | 3 Months Ended Mar 31, 2021 (in thousands) | | :------------------------ | :--------------------------------------- | :--------------------------------------- | | Research and development | $2,027 | $579 | | General and administrative | $1,103 | $672 | | Total | $3,130 | $1,251 | - As of March 31, 2022, unrecognized stock-based compensation cost was $38.7 million, to be recognized over an estimated weighted average period of 3.32 years[98] NOTE 11. Net Loss Per Share Basic and diluted net loss per share for Q1 2022 was $(0.20), compared to $(0.14) in Q1 2021, with potentially dilutive securities excluded due to the net loss Net Loss Per Share Calculation (in thousands, except per share data) | Metric | 3 Months Ended Mar 31, 2022 | 3 Months Ended Mar 31, 2021 | | :---------------------------------------- | :-------------------------- | :-------------------------- | | Net loss | $(25,101) | $(16,007) | | Shares used to compute net loss per share | 125,795,255 | 115,422,628 | | Net loss per share – basic and diluted | $(0.20) | $(0.14) | - Potentially dilutive securities (options, restricted stock units, warrants) were excluded from the computation of diluted weighted average shares outstanding because they would have been antidilutive due to the net loss[100] NOTE 12. Subsequent Events Since March 31, 2022, the company issued an additional 560,000 common shares under its ATM offering, generating $2.8 million in net proceeds, with litigation updates in Note 8 - Since March 31, 2022, the Company issued 560,000 shares of common stock under the September 2021 ATM for net proceeds totaling $2.8 million[101] - Changes in the status of litigation since March 31, 2022, are included in Note 8[102] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Vaxart's financial condition, operational results, product pipeline updates, liquidity, capital resources, and critical accounting policies Company Overview and Background Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines using its proprietary VAAST platform, designed to generate broad immune responses against infectious diseases - Vaxart is a clinical-stage biotechnology company primarily focused on the development of oral recombinant vaccines[104] - The vaccines are based on its proprietary Vector-Adjuvant-Antigen Standardized Technology ("VAAST") oral vaccine platform[104] - Oral vaccines are designed to generate broad and durable immune responses and are administered using a room temperature-stable tablet[104] Business Update Regarding COVID-19 The COVID-19 pandemic continues to pose challenges, but Vaxart has maintained operations without material interruptions while assessing its impact on business, supply chain, and clinical trials - The COVID-19 outbreak has presented a substantial public health and economic challenge, affecting business operations and financial markets[107] - Vaxart has been able to continue operations without material interruptions but is assessing the potential impact on its business, expenses, supply chain, and clinical trials[108] - Recovery from negative impacts may be slowed or reversed by factors such as the emergence of coronavirus strains with mutated S proteins[108] Our Product Pipeline Vaxart is developing several oral tablet vaccine candidates for SARS-CoV-2, norovirus, influenza, RSV, and HPV, with ongoing clinical trials and promising results in efficacy and immunogenicity - A Phase 2a clinical study for the S-only SARS-CoV-2 vaccine candidate (VXA-CoV2-1.1-S) commenced dosing in October 2021, with Part 1 data expected in Q3 2022[111] - Vaxart's bivalent norovirus vaccine demonstrated robust immunogenicity in Phase 1b, with no cross-interference between GI.1 and GII.4 strains[115] - The H1 influenza oral tablet vaccine reduced clinical disease by 39% relative to placebo in a Phase 2 challenge study, outperforming Fluzone (27%)[119] - The influenza vaccine elicited a significant expansion of mucosal homing receptor plasmablasts, indicating a protective mucosal immune response[120] - Early development programs include RSV vaccine and an HPV therapeutic vaccine candidate, which showed T cell responses and tumor reduction in mouse models[122][123] Financial Operations Overview Vaxart's revenue sources include royalty revenue from Inavir sales and non-cash royalty revenue, with research and development expenses expected to increase as vaccine candidates advance through clinical trials - Revenue from customer service contracts of $13,000 in Q1 2021 has now been completed[126][138] - Royalty revenue is earned from Inavir sales in Japan, net of amounts recognized as non-cash royalty revenue related to the sale of future royalties, with the agreement expiring in December 2029[127] - Non-cash royalty revenue related to the sale of future royalties was $85,000 in Q1 2022, a decrease from $493,000 in Q1 2021, due to reduced Inavir sales[128][139] - Research and development expenses are recognized as incurred, with significant external costs for manufacturing and contract research organizations (CROs)[131][132] - R&D expenses are expected to increase in 2022 and beyond as vaccine candidates advance through clinical trials and commercial launch preparations[133] Results of Operations Total revenue decreased by 83% to $85,000 in Q1 2022, while operating expenses increased by 55% to $24.86 million, leading to a 57% increase in net loss to $25.10 million Consolidated Results of Operations (in thousands) | Metric | 3 Months Ended Mar 31, 2022 (in thousands) | 3 Months Ended Mar 31, 2021 (in thousands) | % Change | | :------------------------ | :--------------------------------------- | :--------------------------------------- | :------- | | Total Revenue | $85 | $506 | (83)% | | Total Operating Expenses | $24,861 | $16,017 | 55% | | Operating Loss | $(24,776) | $(15,511) | 60% | | Net Loss | $(25,101) | $(16,007) | 57% | - Research and development expenses increased by $8.1 million (81%) due to higher personnel costs, stock-based compensation, facilities allocation, and manufacturing/clinical expenses for COVID-19 and norovirus vaccine candidates[142] - General and administrative expenses increased by $714,000 (12%) primarily due to increased personnel costs, including stock-based compensation[144] - Net non-operating expenses decreased by 33% to $305,000, driven by higher interest income and a reduction in non-cash interest expense related to the sale of future royalties[145][146] Liquidity and Capital Resources As of March 31, 2022, Vaxart had $157.0 million in cash and marketable securities, believing existing funds are sufficient for at least one year, but anticipating the need for further capital thereafter - As of March 31, 2022, the Company had approximately $157.0 million of cash, cash equivalents, and marketable securities[150] - An additional $2.8 million in net proceeds from common stock sales under the September 2021 ATM was received after March 31, 2022, with approximately $92 million still available[150] - Existing funds are believed to be sufficient for at least one year, but further capital will be needed thereafter, potentially through additional securities sales, debt financing, or collaboration agreements[151][152] Cash Flows Net cash used in operating activities increased to $25.11 million in Q1 2022, while investing activities provided $3.73 million and financing activities significantly decreased to $1.04 million Consolidated Cash Flows (in thousands) | Cash Flow Category | 3 Months Ended Mar 31, 2022 (in thousands) | 3 Months Ended Mar 31, 2021 (in thousands) | | :---------------------------------- | :--------------------------------------- | :--------------------------------------- | | Net cash used in operating activities | $(25,113) | $(16,592) | | Net cash provided by (used in) investing activities | $3,732 | $(20,559) | | Net cash provided by financing activities | $1,040 | $67,592 | - The increase in cash used in operating activities was due to a higher net loss and an increase in working capital[155] - Net cash provided by investing activities was primarily due to $13.6 million from maturities of investments, partially offset by $8.5 million in purchases of investments[18][156] - Net cash provided by financing activities decreased significantly due to lower net proceeds from the issuance of common stock through ATM facilities[157] Contractual Obligations and Commercial Commitments As of March 31, 2022, Vaxart's total contractual obligations and commercial commitments amounted to $71.31 million, including long-term debt related to HCRP royalties, operating leases, and purchase obligations Contractual Obligations and Commercial Commitments (in thousands) | Contractual Obligation | Total (in thousands) | < 1 Year (in thousands) | 1 - 3 Years (in thousands) | 3 - 5 Years (in thousands) | > 5 Years (in thousands) | | :--------------------- | :------------------- | :---------------------- | :------------------------- | :------------------------- | :----------------------- | | Long Term Debt, HCRP | $17,790 | $836 | $6,368 | $5,068 | $5,518 | | Operating Leases | $32,831 | $4,041 | $8,479 | $9,634 | $10,677 | | Purchase Obligations | $20,687 | $20,687 | — | — | — | | Total | $71,308 | $25,564 | $14,847 | $14,702 | $16,195 | - Purchase obligations include approximately $6.1 million for leasehold improvements related to an executed but not yet commenced operating lease[67][159] Critical Accounting Policies and Estimates The company's critical accounting policies involve significant management judgments and estimates for accrued R&D expenses, intangible assets, and stock-based compensation, relying on subjective assumptions - Accrued research and development expenses are estimated based on the progress of services provided by third-party service providers, requiring significant judgments and estimates[162][163] - Intangible assets, including developed technology related to Inavir, were revalued at $10.6 million as of December 31, 2021, resulting in a $3.0 million impairment loss, and are amortized over their estimated useful lives[164] - Stock-based compensation fair value is estimated using the Black-Scholes valuation model, which relies on subjective assumptions for expected term, expected volatility, risk-free interest rate, expected dividend (zero), and forfeiture rate[165][166][167][168] Recent Accounting Pronouncements The company reviewed newly-issued accounting pronouncements and concluded that their adoption is not expected to have a material impact on its financial position or results of operations - The adoption of newly-issued accounting pronouncements is not expected to have a material impact on the company's financial position or results of operations[33][170] Item 3. Quantitative and Qualitative Disclosures About Market Risk Vaxart's primary market risk exposure is to interest rate changes on marketable debt securities, considered insignificant due to high credit ratings and short-term investments, with exchange rate sensitivity also insignificant - Exposure to market risk for changes in interest rates relates primarily to investments in marketable debt securities, but is considered insignificant due to high credit quality and short-term nature of investments[171][172] - Exchange rate sensitivity is considered insignificant as most revenue and expenses are denominated in U.S. dollars, despite royalty revenue being based on Japanese yen sales[173] Item 4. Controls and Procedures Management evaluated the effectiveness of disclosure controls and procedures as of March 31, 2022, concluding they were effective, with no material changes in internal control over financial reporting during the quarter - Disclosure controls and procedures were evaluated and concluded to be effective at a reasonable assurance level as of March 31, 2022[174] - No material change in internal control over financial reporting occurred during the quarter ended March 31, 2022[175] - Control systems provide only reasonable, not absolute, assurance that objectives are met due to inherent limitations and resource constraints[176] Part II. Other Information This section provides additional information including legal proceedings, risk factors, and exhibits for the reporting period Item 1. Legal Proceedings The company is involved in various legal proceedings, including shareholder derivative and securities class actions, but does not currently believe any loss is probable or reasonably estimable - Information on legal proceedings is incorporated by reference from Note 8 to the Condensed Consolidated Financial Statements[179] - The company is involved in legal proceedings, but management does not presently believe that any loss is probable or reasonably estimable[180] Item 1A. Risk Factors The company refers to existing risk factors and highlights an additional risk related to the Russia-Ukraine conflict, which could cause geopolitical instability and impact financial condition - Refers to the risks and uncertainties described in Item 1A of the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[181] - The ongoing military conflict between Russia and Ukraine could cause geopolitical instability, economic uncertainty, financial markets volatility, and capital markets disruption, adversely affecting the company's revenue, financial condition, or results of operations[182] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This item is not applicable to the company for the reporting period - Not applicable[183] Item 3. Defaults Upon Senior Securities This item is not applicable to the company for the reporting period - Not applicable[184] Item 4. Mine Safety Disclosures This item is not applicable to the company for the reporting period - Not applicable[185] Item 5. Other Information This item is not applicable to the company for the reporting period - Not applicable[186] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, compensation plans, and certifications - The section lists various exhibits filed with the Form 10-Q, including corporate governance documents, compensation plans, and certifications[187] Signatures This section certifies the report's due authorization and was signed on May 9, 2022, by the President and Chief Executive Officer of Vaxart, Inc Signatures The report was signed on May 9, 2022, by Andrei Floroiu, President and Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) of Vaxart, Inc., certifying its due authorization - The report was signed on May 9, 2022, by Andrei Floroiu, President and Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) of Vaxart, Inc.[192]