Vaxart, Inc.
For the period ended Jun 30, 2025. Filed Aug 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 13, 2025
VXRT$0.550.0%Stored close · as of Jul 8, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001437749-25-016459
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001437749-25-026514
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 110 previous paragraphs and 112 current paragraphs.
76 unchanged; 31 reworded; 4 added; 2 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 34 previous and 34 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (4)
Current report
In June 2025, we reported positive topline results from a Phase 1 clinical trial (Study VXA-109) evaluating our second-generation bivalent norovirus vaccine constructs head-to-head against our first-generation bivalent norovirus vaccine constructs. The open-label, Phase 1 trial was conducted in 60 healthy volunteers who were randomized to receive the first-generation vaccine constructs, an equivalent dose of the second-generation GI.1 and GII.4 vaccine constructs, or a lower dose of the second-generation vaccine constructs (n=20 for each group). The primary immunological endpoint was norovirus blocking antibody assay (NBAA) titer at Day 0 and Day 28. In a Phase 2 challenge study of the first-generation vaccine constructs, these functional NBAA titers were identified as correlates of protection against norovirus infection. Although the study was not powered to determine superiority by statistical methods, the increase in NBAA titers with the second-generation vaccine candidates was sufficiently large (141% for the GI.1 vaccine candidate and 94% for the GII.4 vaccine candidate) to demonstrate statistical significance at the equivalent dose.
Current report
In May 2025 we received approval from HHS BARDA to initiate dosing and proceeded to dose the first patient in the 10,000-participant portion of our ongoing Phase 2b clinical trial comparing our KP.2 COVID-19 vaccine candidate against an approved mRNA KP.2 comparator. As announced on May 27, 2025, the first patient was dosed in the 10,000 participant portion of the study. However, as discussed above, on August 5, 2025, the Company received written notification from ATI in the form of a stop work order directing the Company to stop work on screening and enrollment for the COVID-19 Phase 2b trial under the 2024 ATI-RRPV Contract as of the notification date. The Company may, however, continue efforts associated with the per protocol follow-up of all participants dosed as of the notification date in the study under the terms of the 2024 ATI-RRPV Contract. We currently cannot estimate if any further changes may be agreed in the future regarding the scope and value of the 2024 ATI-RRPV Contract and any implications of such changes on this Phase 2b clinical trial.
Current report
For the six months ended June 30, 2025, general and administrative expenses decreased by $2.8 million, or 22%, compared to the six months ended June 30, 2024. The decrease was primarily due to a decrease in personnel costs, legal and professional fees.
Current report
Purchase obligations. As of June 30, 2025, the Company had approximately $28.2 million of non-cancelable purchase commitments, principally for clinical services which are expected to be paid within the next year. Approximately$24.1 million of non-cancelable purchase commitments are attributable to a third-party vendor that provides clinical services, that is reimbursable at approximately $25.9 million under a cost-plus-fixed-fees arrangement in the ATI-RRPV Contract.
Removed paragraphs (2)
Previous report
With advice from advisors and infectious disease experts, we decided to proceed with a Phase 1, open label, dose ranging clinical trial evaluating our second-generation oral norovirus vaccine constructs head-to-head against our first-generation constructs. The trial will measure safety and immunogenicity, including immune parameters that have correlated to protection in our Phase 2 GI.1 norovirus challenge study. The Phase 1 trial initiated in March 2025 and topline data is expected in the middle of 2025.
Previous report
Purchase obligations. The amounts include an estimate of all open purchase orders and contractual obligations in the ordinary course of business, including commitments with contract manufacturers and suppliers for which we have not received the goods or services. We consider all open purchase orders, which are generally enforceable and legally binding, to be commitments, although the terms may afford us the option to cancel based on our business needs prior to the delivery of goods or performance of services.
Reworded paragraphs (31)
Previous wording
Adult and Elderly. 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 first-generation 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.
Current wording
Adult and Elderly. 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 first-generation 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 30% 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.
Previous wording
If the Phase 1 trial is successful, the next step, pending a partnership or other funding, would be to conduct a Phase 2b safety and immunogenicity study that could potentially begin as early as the second half of 2025. This Phase 2b trial would be followed by an End of Phase 2 meeting with the FDA. A Phase 3 trial could then begin as early as 2026, pending a successful End of Phase 2 meeting and funding.
Current wording
Following the successful outcome of the VXA-109 trial, the next step, pending a partnership or other funding and pending additional input from a potential partner or investor, would be to conduct a Phase 2b safety and immunogenicity study that could potentially begin as early as the second half of 2025. This Phase 2b trial would be followed by an End of Phase 2 meeting with the FDA. A Phase 3 trial could then begin as early as 2026, pending a successful End of Phase 2 meeting and funding.
Previous wording
In June 2024, we entered into an agreement (as modified or amended from time to time, the “2024 ATI-RRPV Contract”) with Advanced Technology International (“ATI”), the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by HHS BARDA. The 2024 ATI-RRPV Contract provides for funding of up to $460.7 million to conduct the Phase 2b study, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain. In February 2025, we entered into Modification No. 5 (the “Modification”) to the 2024 ATI-RRPV Contract. The Modification increased the total amount of funding available for payment to approximately $240.1 million. Subsequently, in February 2025, we received written notification directing the Company to stop work on the 2024 ATI-RRPV Contract, with the exception that we could continue effort associated with the per protocol follow-up for the 400-person cohort. The stop work order was in effect for a period of 90 days and, that within a period of 90 days, ATI, as directed by the U.S. Government, will either cancel the stop work order, extend the stop work, or terminate the work covered by the 2024 ATI-RRPV Contract. Subsequently, in April 2025, the Company received written notification from ATI in the form of a stop work order lift (the “Lift Notice”) that the stop work order had been lifted and that the Company may resume incurring costs, participating in meetings, and communicating with the Government and ATI concerning the project award. The Lift Notice required further discussion between the Company and HHS BARDA regarding costs, timelines, and regulatory pathway agreement. Subsequent to the Company’s receipt of the Lift Notice, the Company had a virtual meeting with HHS BARDA wherein the Company was told that it could proceed with screening for the 10,000-participant portion of the Phase 2b trial.
Current wording
In June 2024, we entered into an agreement (as modified or amended from time to time, the “2024 ATI-RRPV Contract”) with Advanced Technology International (“ATI”), the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by HHS BARDA. The 2024 ATI-RRPV Contract provides for funding of up to $460.7 million to conduct the Phase 2b study, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain. In February 2025, we entered into Modification No. 5 (the “Modification”) to the 2024 ATI-RRPV Contract. The Modification increased the total amount of funding available for payment to approximately $240.1 million. Subsequently, in February 2025, we received written notification directing the Company to stop work on the 2024 ATI-RRPV Contract, with the exception that we could continue efforts associated with the per protocol follow-up for the 400-participant cohort. The stop work order was to be in effect for a period of 90 days. Subsequently, in April 2025, the Company received written notification from ATI in the form of a stop work order lift (the “Lift Notice”) that the stop work order had been lifted and that the Company may resume incurring costs, participating in meetings, and communicating with the Government and ATI concerning the project award. The Lift Notice required further discussion between the Company and HHS BARDA regarding costs, timelines, and regulatory pathway agreement. Subsequent to the Company’s receipt of the Lift Notice, the Company had received approval from HHS BARDA to proceed with dosing for the 10,000-participant portion of the Phase 2b trial. On August 5, 2025, the Company received written notification from ATI in the form of a stop work order directing the Company to stop work on screening and enrollment for the COVID-19 Phase 2b trial under the 2024 ATI-RRPV Contract as of the date of the notice. The Company may, however, continue efforts associated with the per protocol follow-up of all participants dosed as of the notification date in the study under the terms of the 2024 ATI-RRPV Contract. As of the notification date, the Company had enrolled approximately half of the targeted number of participants for the study. As of August 12, 2025, the Company has not been provided with any further details, including the reason for such stop work order. Consistent with the stop work order, the Company intends to continue all work as planned with the per protocol follow-up of all participants dosed as of the notification date in the study.
Previous wording
The Phase 2b study is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The study design anticipates enrolling approximately 10,400 healthy adults 18 years and older in the U.S. with approximately 5,200 receiving our COVID-19 vaccine candidate and approximately 5,200 receiving an approved mRNA comparator. The study will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.
Current wording
The Phase 2b study is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The study design anticipates enrolling approximately 10,400 healthy adults 18 years and older in the U.S. with approximately 5,200 receiving our COVID-19 vaccine candidate and approximately 5,200 receiving an approved strain matched mRNA comparator. The study will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65.
Previous wording
In the second half of 2024, we initiated and completed enrollment of the sentinel cohort of the Phase 2b study consisting of 400 individuals comparing our XBB COVID-19 vaccine candidate against an approved mRNA XBB comparator. In January 2025, an independent data safety monitoring board (“DSMB”) recommended the study to proceed without modifications based on initial safety assessment of 30-day data from the sentinel cohort. If we receive approval from HHS BARDA, we will progress to the next part of the study to enroll approximately 10,000 participants comparing our KP.2 COVID-19 vaccine candidate against an approved mRNA KP.2 comparator.
Current wording
In the second half of 2024, we initiated and completed enrollment of the sentinel cohort of the Phase 2b study consisting of 400 individuals comparing our XBB COVID-19 vaccine candidate against an approved mRNA XBB comparator. In January 2025, an independent data safety monitoring board (“DSMB”) recommended the study to proceed without modifications based on initial safety assessment of 30-day data from the sentinel cohort.
Previous wording
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 influenza vaccine candidate.
Current wording
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 tri-valent seasonal influenza vaccine candidate.
Previous wording
In January 2024, we were awarded the 2024 ASPR-BARDA Contract by HHS BARDA, with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. Revenue from government contracts recognized on the 2024 ASPR-BARDA Contract was zero and $1.6 million for the three months ended March 31, 2025 and 2024, respectively, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract.
Current wording
In January 2024, we were awarded the 2024 ASPR-BARDA Contract by HHS BARDA, with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. Revenue from government contracts recognized on the 2024 ASPR-BARDA Contract was zero and $6.2 million for the three months ended June 30, 2025 and 2024, respectively, and zero and $7.8 million for the six months ended June 30, 2025 and 2024, respectively, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract.
Previous wording
In June 2024, we entered into the 2024 ATI-RRPV Contract. In the second half of 2024, the 2024 ATI-RRPV Contract was modified to increase funding and expand the scope to include the manufacture of a vaccine candidate targeting the KP.2 strain and acquire an approved mRNA vaccine targeting the KP.2 strain. Pursuant to the 2024 ATI-RRPV Contract (as modified or amended from time to time), we may receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the FDA. The 2024 ATI-RRPV Contract makes available an aggregate amount of up to $240.1 million, consisting of firm fixed price amounts totaling $67.9 million and reimbursement of costs incurred in trial preparation and execution activities. The 2024 ATI-RRPV Contract further contemplates additional funding up to $220.6 million if we and HHS BARDA decide to continue with the Phase 2b comparative study. Revenue from government contracts recognized on the 2024 ATI-RRPV Contract was $19.3 million for the three months ended March 31, 2025 based on costs incurred and the achievement of firm fixed-price milestones under the 2024 ATI-RRPV Contract. For further information about the stop work order and the lift of the stop work order, see the section above titled “—Our Product Pipeline” in the “Coronavirus Vaccine” discussion.
Current wording
In June 2024, we entered into the 2024 ATI-RRPV Contract. In the second half of 2024, the 2024 ATI-RRPV Contract was modified to increase funding and expand the scope to include the manufacture of a vaccine candidate targeting the KP.2 strain and acquire an approved mRNA vaccine targeting the KP.2 strain. Pursuant to the 2024 ATI-RRPV Contract (as modified or amended from time to time), we may receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the FDA. The 2024 ATI-RRPV Contract makes available an aggregate amount of up to $240.1 million, consisting of firm fixed price amounts totaling $67.9 million and reimbursement of costs incurred in trial preparation and execution activities. The 2024 ATI-RRPV Contract further contemplates additional funding up to $220.6 million if we and HHS BARDA decide to continue with the Phase 2b comparative study. Revenue from government contracts recognized on the 2024 ATI-RRPV Contract was $39.7 million and $0.2 million for the three months ended June 30, 2025 and 2024, respectively, and $59.0 million and $0.2 million for the six months ended June 30, 2025 and 2024, respectively, based on costs incurred and the achievement of firm fixed-price milestones under the 2024 ATI-RRPV Contract. For further information about the August 5, 2025 stop work order relating to the 2024 ATI-RRPV Contract, see the section above titled “—Our Product Pipeline” in the “Coronavirus Vaccine” discussion.
Previous wording
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 for the three months ended March 31, 2025 and 2024 (in thousands):
Current wording
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 for the three and six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
The following table presents period-over-period changes in selected items in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024 (in thousands, except percentages):
Current wording
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 six months ended June 30, 2025 and 2024 (in thousands, except percentages):
Previous wording
The following table summarizes the period-over-period changes in our revenues for the three months ended March 31, 2025 and 2024 (in thousands, except percentages):
Current wording
The following table summarizes the period-over-period changes in our revenues for the three and six months ended June 30, 2025 and 2024 (in thousands, except percentages):
Previous wording
For the three months ended March 31, 2025 and 2024, non-cash royalty revenue related to sale of future royalties from Daiichi Sankyo was $1.6 million and $0.6 million, respectively. We continue to have non-cash royalty revenue as all royalties received for the three months ended March 31, 2025 and 2024 were required to be paid to HCRP.
Current wording
For the three months ended June 30, 2025 and 2024, non-cash royalty revenue related to sale of future royalties from Daiichi Sankyo was zero and $37,000, respectively, and for thesix months ended June 30, 2025 and 2024, was $1.6 million and $0.6 million, respectively. We continue to have non-cash royalty revenue as all royalties received for the three and six months ended June 30, 2025 and 2024 were required to be paid to HCRP.
Previous wording
For the three months ended March 31, 2025 and 2024, revenue from government contracts was $19.3 million and $1.6 million, respectively. The revenue from government contracts consists of the 2024 ASPR-BARDA Contract awarded to us in January 2024 and the 2024 ATI-RRPV Contract awarded to us in June 2024. Revenue from the 2024 ASPR-BARDA Contract was zero and $1.6 million for the three months ended March 31, 2025 and 2024, respectively. Revenue from the ATI-RRPV Contract was $19.3 million for the three months ended March 31, 2025.
Current wording
For the three months ended June 30, 2025 and 2024, revenue from government contracts was $39.7 million and $6.4 million, respectively, and for the six months ended June 30, 2025 and 2024, was $59.0 million and $8.0 million, respectively. The revenue from government contracts consists of the 2024 ASPR-BARDA Contract awarded to us in January 2024 and the 2024 ATI-RRPV Contract awarded to us in June 2024. Revenue from the 2024 ASPR-BARDA Contract was zero and $6.2 million for the three months ended June 30, 2025 and 2024, respectively, and zero and $7.8 million for the six months ended June 30, 2025 and 2024, respectively. Revenue from the ATI-RRPV Contract was $39.7 million and $0.2 million for the three months ended June 30, 2025 and 2024, respectively, and $59.0 million and $0.2 million for the six months ended June 30, 2025 and 2024, respectively.
Previous wording
The following table summarizes the period-over-period changes in our operating expenses for the three months ended March 31, 2025 and 2024 (in thousands, except percentages):
Current wording
The following table summarizes the period-over-period changes in our operating expenses for the three and six months ended June 30, 2025 and 2024 (in thousands, except percentages):
Previous wording
For the three months ended March 31, 2025, research and development expenses increased by $11.7 million, or 62%, compared to the three months ended March 31, 2024. The increase was primarily due to an increase in clinical trial expenses related to our COVID-19 and norovirus vaccine candidates, partially offset by a decrease in preclinical and manufacturing expenses.
Current wording
For the three months ended June 30, 2025, research and development expenses increased by $32.3 million, or 185%, compared to the three months ended June 30, 2024. The increase was primarily due to an increase in clinical trial expenses related to our COVID-19 and norovirus vaccine candidates, partially offset by a decrease in preclinical, manufacturing expenses and personnel costs.
Previous wording
For the three months ended March 31, 2025, general and administrative expenses decreased by $2.2 million, or 30%, compared to the three months ended March 31, 2024. The decrease was primarily due to a decrease in stock-based compensation expense, personnel costs and legal and other professional fees.
Current wording
For the three months ended June 30, 2025, general and administrative expenses decreased by $0.6 million, or 11%, compared to the three months ended June 30, 2024. The net decrease was primarily due to a decrease in professional and legal fees.
Previous wording
The following table summarizes the period-over-period changes in our non-operating income for the three months ended March 31, 2025 and 2024 (in thousands, except percentages):
Current wording
The following table summarizes the period-over-period changes in our non-operating income for the three and six months ended June 30, 2025 and 2024 (in thousands, except percentages):
Previous wording
For thethree months ended March 31, 2025, we recorded interest income of $0.4 million, a 13% decrease from the $0.5 million interest income recorded in thethree months ended March 31, 2024. The decrease is primarily due to the decrease in our cash, cash equivalents and investments balance.
Current wording
For thethree months ended June 30, 2025, we recorded interest income of $0.3 million, a 25% decrease from the $0.4 million interest income recorded in thethree months ended June 30, 2024. For the six months ended June 30, 2025, we recorded interest income of $0.7 million, a 19% decrease from the $0.9 million of interest income recorded in the six months ended June 30, 2024. The decrease is primarily due to the decrease in our cash, cash equivalents and investments balance.
Previous wording
Non-cash interest expense related to sale of future royalties representing imputed interest on the unamortized portion of the sale of future royalties liability, increased to $1.0 million for the three months ended March 31, 2025, from the $0.8 million for the three months ended March 31, 2024, due to an increase in non-cash royalty revenue payable to HCRP.
Current wording
Non-cash interest expense related to sale of future royalties representing imputed interest on the unamortized portion of the sale of future royalties liability, increased to $0.7 million for the three months ended June 30, 2025, from the $0.6 million for the three months ended June 30, 2024, and to $1.7 million for the six months ended June 30, 2025, from the $1.4 million for the six months ended June 30, 2024, due to an increase in non-cash royalty revenue payable to HCRP.
Previous wording
The following table summarizes the period-over-period changes in our provision for income taxes for the three months ended March 31, 2025 and 2024 (in thousands, except percentages):
Current wording
The following table summarizes the period-over-period changes in our provision for income taxes for the three and six months ended June 30, 2025 and 2024 (in thousands, except percentages):
Previous wording
The provision for income taxes was $95,000 and $45,000 for the three months ended March 31, 2025 and 2024, respectively. The tax charge relates to interest on an intercompany loan from a foreign subsidiary and a 5% withholding tax on royalty revenue earned on sales of Inavir in Japan, which is potentially recoverable as a foreign tax credit but expensed because we record a 100% valuation allowance against our deferred tax assets. The amount of income tax expense recorded is directly proportional to Inavir royalties, including the portion that we pass through to HCRP.
Current wording
The provision for income taxes was $20,000 and $21,000 for the three months ended June 30, 2025 and 2024, respectively, and $115,000 and $66,000 for the six months ended June 30, 2025 and 2024, respectively. The tax charge relates to interest on an intercompany loan from a foreign subsidiary, and a 5% withholding tax on royalty revenue earned on sales of Inavir in Japan, which is potentially recoverable as a foreign tax credit but expensed because we record a 100% valuation allowance against our deferred tax assets. The amount of foreign withholding tax expense recorded is directly proportional to Inavir royalties, including the portion that we pass through to HCRP.
Previous wording
In March 2025, the Company entered into an At the Market Offering Agreement (the “March 2025 ATM”) with Citizens JMP Securities, LLC (“Citizens”) and B. Riley Securities, Inc. (“B. Riley” and, together with Citizens, the “Managers”), pursuant to which the Company may offer and sell, from time to time through the Managers, shares of its common stock having an aggregate offering price of up to $50 million. The shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-270671), as previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The Company filed a prospectus supplement, dated March 21, 2025, with the SEC in connection with the offer and sale of the shares under the March 2025 ATM. The Company will pay the Managers a placement fee of up to 3% of the gross sale price from each sale of the shares under the March 2025 ATM. As of March 31, 2025, the Company has not sold any shares under the March 2025 ATM.
Current wording
In March 2025, the Company entered into an At the Market Offering Agreement (the “March 2025 ATM”) with Citizens JMP Securities, LLC (“Citizens”) and B. Riley Securities, Inc. (“B. Riley” and, together with Citizens, the “Managers”), pursuant to which the Company may offer and sell, from time to time through the Managers, shares of its common stock having an aggregate offering price of up to $50 million. The shares will be sold pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-270671), as previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The Company filed a prospectus supplement, dated March 21, 2025, with the SEC in connection with the offer and sale of the shares under the March 2025 ATM. The Company will pay the Managers a placement fee of up to 3% of the gross sale price from each sale of the shares under the March 2025 ATM. During the six months ended June 30, 2025, 382,700 shares were issued and sold under the March 2025 ATM for gross proceeds of $0.2 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $0.1 million. As of June 30, 2025, approximately $48.4 million of our common stock remained available for issuance and sale pursuant to the March 2025 ATM.
Previous wording
In June 2024, we entered into the 2024 ATI-RRPV Contract. Pursuant to the 2024 ATI-RRPV Contract, we may receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the FDA, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain. As of March 31, 2025, we have received $85.6 million of cash payments under the 2024 ATI-RRPV Contract. Subsequent to March 31, 2025, through the filing date of this Quarterly Report on Form 10-Q, we have received $9.2 million under the 2024 ATI-RRPV Contract.
Current wording
In June 2024, we entered into the 2024 ATI-RRPV Contract. Pursuant to the 2024 ATI-RRPV Contract, we may receive funding of up to $460.7 million to conduct a Phase 2b comparative study evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the FDA, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain. As of June 30, 2025, we have received $98.9 million of cash payments under the 2024 ATI-RRPV Contract. Subsequent to June 30, 2025, through the filing date of this Quarterly Report on Form 10-Q, we have received $4.3 million under the 2024 ATI-RRPV Contract. On August 5, 2025, the Company received written notification from ATI in the form of a stop work order directing the Company to stop work on screening and enrollment for the COVID-19 Phase 2b trial under the 2024 ATI-RRPV Contract as of the notification date. The Company may, however, continue efforts associated with the per protocol follow-up of all participants dosed as of the notification date in the study under the terms of the 2024 ATI-RRPV Contract. As of the notification date the Company had enrolled approximately half of the targeted number of participants for the study. As of August 12, 2025, the Company has not been provided with any further details, including the reason for such stop work order. Management is currently evaluating the effect of the stop work order on its liquidity and capital resources.
Previous wording
As of March 31, 2025, we had approximately $41.9 million of cash, cash equivalents and short-term investments. Our cash, cash equivalents and investments are not sufficient to fund our planned operations for a period of 12 months from the date of issuance of this Quarterly Report. To continue operations, we expect that we will need to raise further capital, through the sale of additional securities or otherwise; however, adequate funding may not be available to us on acceptable terms, or at all, particularly in light of current economic uncertainty, high interest rates, rising inflation, tariffs, and the potential for local and/or global economic recession. Our future capital requirements and the adequacy of our available funds will depend on many factors, most notably our ability to successfully commercialize our products and services.
Current wording
As of June 30, 2025, we had approximately $26.3 million of cash, cash equivalents and short-term investments. Our cash, cash equivalents and investments are not sufficient to fund our planned operations for a period of 12 months from the date of issuance of this Quarterly Report. To continue operations, we expect that we will need to raise further capital, through the sale of additional securities or otherwise; however, adequate funding may not be available to us on acceptable terms, or at all, particularly in light of current economic uncertainty, high interest rates, rising inflation, tariffs, and the potential for local and/or global economic recession. Our future capital requirements and the adequacy of our available funds will depend on many factors, most notably our ability to successfully commercialize our products and services.
Previous wording
We experienced negative cash flow from operating activities for the three months ended March 31, 2025 and 2024, in the amounts of $9.6 million and $21.2 million, respectively. The cash used in operating activities in the three months ended March 31, 2025, was due to cash used to fund a net loss of $15.6 million, partially offset by a decrease in working capital of $3.4 million, and adjustments for net non-cash expenses related to depreciation and amortization, accretion 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 $2.6 million. The cash used in operating activities in the three months ended March 31, 2024, was due to cash used to fund a net loss of $24.4 million and an increase in working capital of $0.8 million, partially offset by adjustments for net non-cash expenses related to depreciation and amortization, accretion of discount on investments, net, stock-based compensation, non-cash interest expense related to sale of future royalties and non-cash revenue related to sale of future royalties totaling $4.0 million.
Current wording
We experienced negative cash flow from operating activities for the six months ended June 30, 2025 and 2024, in the amounts of $25.5 million and $33.2 million, respectively. The cash used in operating activities in the six months ended June 30, 2025, was due to cash used to fund a net loss of $30.6 million, partially offset by a decrease in working capital of $1.0 million, and adjustments for net non-cash expenses related to depreciation and amortization, accretion 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 $6.0 million. The cash used in operating activities in the six months ended June 30, 2024, was due to cash used to fund a net loss of $40.9 million and an decrease in working capital of $1.1 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 $8.7 million.
Previous wording
In the three months ended March 31, 2025, we received $13.4 million from maturities of investments, net of purchases, and used $0.1 million of cash to purchase property and equipment. In the three months ended March 31, 2024, we used $4.9 million to purchase investments, net of maturities, and used $0.1 million to purchase property and equipment.
Current wording
In the six months ended June 30, 2025, we received $20.5 million from maturities of investments, net of purchases, and used $27,000 of cash to purchase property and equipment. In the six months ended June 30, 2024, we used $14.1 million to purchase investments, net of maturities, and used $0.5 million of cash to purchase property and equipment.
Previous wording
In the three months ended March 31, 2025, we used $0.2 million to acquire common stock to settle employee tax withholding liabilities. In the three months ended March 31, 2024, we received net proceeds of $8.4 million from the sale of our common stock under the September 2021 ATM and net proceeds of $9.9 million from the sale of our common stock under the 2024 Securities Purchase Agreement, partially offset by $0.2 million from common stock acquired to settle employee tax withholding liabilities.
Current wording
In the six months ended June 30, 2025, we used $0.2 million to acquire common stock to settle employee tax withholding liabilities, and received net proceeds of $53,000 from the sale of our common stock under the March 2025 ATM. In the six months ended June 30, 2024, we received net proceeds of $37.6 million from the sale of our common stock under the June 2024 Offering, net proceeds of $8.8 million from the sale of our common stock under the September 2021 ATM and net proceeds of $9.9 million from the sale of our common stock under the 2024 Securities Purchase Agreement, partially offset by $0.2 million from common stock acquired to settle employee tax withholding liabilities.
Previous wording
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.
Current wording
Operating leases. Operating lease amounts include future minimum lease payments under all our non-cancelable operating leases with an initial term in excess of one year.
Previous wording
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. The fair value as of March 31, 2025 is being amortized on a straight-line basis over the remaining period of 4.6 years.
Current wording
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. The fair value as of June 30, 2025 is being amortized on a straight-line basis over the remaining period of 4.4 years and 2.5 years for developed technology and intellectual property, respectively.
Previous wording
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 the three months ended March 31, 2025, a notional 10% decrease in expected term would have reduced the fair value and the related compensation expense by approximately 2.2%.
Current wording
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 the six months ended June 30, 2025, a notional 10% decrease in expected term would have reduced the fair value and the related compensation expense by approximately 2.2%.
Previous wording
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 the three months ended March 31, 2025, a notional 10% decrease in expected volatility (from 126.5% to 113.8%) would have reduced the fair value and the related compensation expense by approximately 4.1%.
Current wording
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 the six months ended June 30, 2025, a notional 10% decrease in expected volatility (from 126.6% to 113.9%) would have reduced the fair value and the related compensation expense by approximately 4.2%.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, research and development expenses increased by $44.0 million, or 121%, compared to the six months ended June 30, 2024. The increase was primarily due to an increase in clinical trial expenses related to our COVID-19 and norovirus vaccine candidates, partially offset by a decrease in manufacturing, pre-clinical expenses and personnel costs.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Item 2. Management****’**s Discussion and Analysis of Financial Condition and Results of Operations