Vaxart, Inc.
For the period ended Dec 31, 2024. Filed Mar 20, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 20, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-14.
0001437749-24-007865
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-20.
0001437749-25-008572
ITEM 7. 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 85 previous paragraphs and 88 current paragraphs.
48 unchanged; 21 reworded; 18 added; 16 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 27 previous and 27 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 (18)
Current report
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 $8.7 million and zero for the years ended December 31, 2024 and 2023, respectively, based on the achievement of certain milestones under the 2024 ASPR-BARDA Contract.
Current report
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. As of December 31, 2024, the 2024 ATI-RRPV Contract makes available an aggregate amount of up to $134.2 million, consisting of firm fixed price amounts totaling $67.9 million and reimbursement of costs incurred in trial preparation and execution activities. As of December 31, 2024, the 2024 ATI-RRPV Contract further contemplates additional funding up to $326.5 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 $16.2 million and zero for the years ended December 31, 2024 and 2023, respectively, based on costs incurred and the achievement of firm fixed-price milestones under the 2024 ATI-RRPV Contract. 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. On February 21, 2025, we received the “Notices” (discussed above) directing us to stop work on all of our efforts with respect to the 2024 ATI-RRPV Contract, with the exception that we may continue efforts associated with the per protocol follow-up for the 400-person cohort. The Notices stated that the stop work order is in effect for a period of 90 days after the date of the Notices 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 letter.
Current report
Total Revenue
Current report
The following table summarizes the period-over-period changes in our revenue for years ended December 31 (in thousands, except percentages):
Current report
For the year ended December 31, 2024 and 2023, revenue from government contracts was $24.9 million and zero, 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 $8.7 million for the year ended December 31, 2024. Revenue from the ATI-RRPV Contract was $16.2 million for the year ended December 31, 2024.
Current report
Non-Operating (Expense) Income
Current report
For the year ended December 31, 2024, we recorded interest income of $2.5 million, a 4% decrease from the $2.7 million interest income recorded in the year ended December 31, 2023. The decrease is primarily due to lower interest rates in 2024, partially offset by a higher cash, cash equivalents and investments balance.
Current report
In January 2024, we entered into a securities purchase agreement (the “2024 Securities Purchase Agreement”) with RA Capital Healthcare Fund, L.P. pursuant to which 15,384,615 shares of our common stock were sold to RA Capital Healthcare Fund, L.P. at an offering price of $0.65 per share. The gross proceeds from the 2024 Securities Purchase Agreement were $10.0 million and, after deducting offering expenses, the net proceeds were $9.9 million.
Current report
In January 2024, we were awarded the 2024 ASPR-BARDA Contract with a base and all options value of $9.3 million. Under the 2024 ASPR-BARDA Contract, we received an award to support clinical trial planning activities for a Phase 2b clinical trial that would compare our XBB vaccine candidate to an mRNA comparator to evaluate efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events. The 2024 ASPR-BARDA Contract originally had a period of performance term that was set to expire in July 2024, but we entered into an amendment in July 2024 that extended the period of performance expiration date into October 2024. BARDA and Vaxart are currently discussing contract closeout for the 2024 ASPR-BARDA Contract. As of December 31, 2024, we received approximately $9.3 million of cash payments under the 2024 ASPR-BARDA Contract.
Current report
In June 2024, we entered into an underwriting agreement with Oppenheimer & Co. Inc., relating to the issuance and sale by us in an underwritten registered direct offering (the “June 2024 Offering”) of 50,000,000 shares of our common stock at a price of $0.80 per share. The gross proceeds to us from such offering were $40.0 million, and after deducting the underwriting discounts and commissions and other offering expenses paid by us, the net proceeds were $37.5 million.
Current report
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 U.S. Food and Drug Administration, manufacture a COVID-19 vaccine candidate targeting the KP.2 strain, and acquire an approved mRNA vaccine targeting the KP.2 strain. As of December 31, 2024, we have received $72.0 million of cash payments under the 2024 ATI-RRPV Contract. Subsequent to December 31, 2024, through the filing date of this Annual Report on Form 10-K, we have received $7.2 million under the 2024 ATI-RRPV Contract. On February 21, 2025, we received the Notices directing us to stop work on all of our efforts with respect to the 2024 ATI-RRPV Contract, with the exception that we may continue efforts associated with the per protocol follow-up for the 400-person cohort. The Notices stated that the stop work order is in effect for a period of 90 days after the date of the Notices 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 letter.
Current report
As of December 31, 2024, we had approximately $51.7 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 Annual Report. To continue operations, we expect that we will need to raise further capital, through the sale of additional securities or otherwise. 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 report
Net Cash (Used in) Provided by Investing Activities
Current report
Share-based payment arrangements. As of December 31, 2024, the unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs expected to vest was $13.5 million, which we expect to recognize over an estimated weighted average period of 2.1 years. See Note 10 to the Consolidated Financial Statements in Part II, Item 8 for further details on stock-based compensation expense recognized.
Current report
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 December 31, 2024, is being amortized on a straight-line basis over the remaining period of 4.9 years.
Current report
Revenue from Government Contracts
Current report
Under firm fixed-price milestone contracts, we recognize the firm fixed-price revenue as the milestones are substantially complete and the firm fixed-price for the milestone is earned (“firm fixed-price milestone”). Cash received in advance of the completion of a firm fixed-price milestone will be recorded as deferred revenue until the milestone has been substantially completed and earned. Under cost reimbursable contracts, we recognize revenue as allowable costs are incurred and the fixed fee is earned (“cost-plus-fixed-fee”). Reimbursable costs under the contract primarily include direct labor, subcontract costs, materials, equipment, travel, and approved overhead and indirect costs. Fixed fees under cost reimbursable contracts are earned in proportion to the allowable costs incurred in performance of the work relative to total estimated contract costs, with such costs incurred representing a reasonable measurement of the proportional performance of the work completed.
Current report
Payments to us under cost reimbursable contracts are provisional payments subject to adjustment upon annual audit by the government. Management believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. When the final determination of the allowable costs for any year has been made, revenue and billings may be adjusted accordingly in the period that the adjustment is known.
Removed paragraphs (16)
Previous report
The Company re-qualified as a smaller reporting company as of December 31, 2022 and, therefore, is no longer subject to the requirements for auditor attestation for internal control over financial reporting.
Previous report
GrantRevenue
Previous report
Total Revenues
Previous report
The following table summarizes the period-over-period changes in our revenues for years ended December 31 (in thousands, except percentages):
Previous report
Grant Revenue
Previous report
We expect to incur significant research and development expenses for manufacturing and clinical trials related to our COVID-19 vaccine candidate in 2024.
Previous report
Impairment of Intangible Assets
Previous report
Impairment of intangible assets were zero and $4.3 million for the years ended December 31, 2023 and 2022, respectively. The partial impairment of developed technology in the year ended December 31, 2022, related to royalty revenue receivable for the Inavir flu vaccine in Japan which we have lowered our projections, principally due to increased quarantining, social distancing and mask wearing due to the COVID-19 pandemic.
Previous report
Other Income (Expense)
Previous report
For the year ended December 31, 2023, we recorded net non-operating income of $1.1 million, compared to net non-operating income of $6.9 million in 2022.
Previous report
The gain on remeasurement of future royalty liability in 2022 arose due to the lowered projections of amounts payable to HCRP, as royalties from Inavir flu vaccine in Japan have declined since the start of the COVID-19 pandemic and we lowered our projections, principally due to increased quarantining, social distancing and mask wearing due to the COVID-19.
Previous report
As of December 31, 2023, we had $39.7 million of cash, cash equivalents and investments. In January 2024, Vaxart completed an offering (the “January 2024 Offering”) in which 15,384,615 shares of its common stock were sold at an offering price of $0.65 per share pursuant to the Company’s effective shelf registration statement on Form S-3 (the “2023 Shelf Registration”). The gross proceeds from the January 2024 Offering were $10.0 million and, after deducting underwriting discounts, commission and estimated offering expenses, net proceeds were $9.9 million. See Note 15 of the Consolidated Financial Statements in Part II, Item 8 for further details.
Previous report
In the first quarter of 2023, the Company implemented a restructuring plan to reduce operating costs and better align its workforce with the needs of its business. The plan resulted in a reduction of approximately 27% of the Company’s workforce and severance costs of $0.5 million for the year ended December 31, 2023.
Previous report
Our expectation is that we will continue to generate operating losses and negative operating cash flows in the future and the need for additional funding to support our planned operations raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that the consolidated financial statements are issued.
Previous report
Net Cash Provided by (Used in) Investing Activities
Previous report
Intangible assets acquired in the Merger were initially recorded at their estimated fair values of $20.3 million for developed technology related to Inavir which was, until it was revalued, being amortized on a straight-line basis over the estimated period of future royalties of 11.75 years. The developed technology related to Inavir was revalued at $5.0 million as of December 31, 2022, resulting in an impairment loss of $4.3 million being recorded. These valuations were prepared by an independent third party based on discounted cash flows of estimated future revenue streams, which are highly subjective. The fair value as of December 31, 2023, is being amortized on a straight-line basis over the remaining period of future royalties of 5.9 years.
Reworded paragraphs (21)
Previous wording
In April 2016, Aviragen sold certain royalty rights related to Inavir in the Japanese market for $20.0 million to HealthCare Royalty Partners III, L.P. (“HCRP”). Under the terms of our agreement with HCRP, during the first royalty interest period of April 1, 2016 through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by us. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by us. A shortfall occurs when, during an annual period ending on March 31 st, for the first royalty interest period of April 1, 2016 through March 31, 2025, the Company’s royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, we are not obligated to pay HCRP any royalty payment beyond what the Company is paid from Daiichi Sankyo Company Limited (“Daiichi Sankyo”). The cumulative remaining shortfall amount is the aggregate amount of the shortfall for each annual period, which was $7.0 million and $4.3 million as of December 31, 2023 and 2022, respectively. 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 and 2021 when the fair value was estimated to be $5.0 million and $10.6 million, respectively, resulting in a revaluation gain of $7.0 million in the year ended December 31, 2022 and $3.8 million in the year ended December 31, 2021. Even though we do not currently 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.
Current wording
In April 2016, Aviragen sold certain royalty rights related to Inavir in the Japanese market for $20.0 million to HealthCare Royalty Partners III, L.P. (“HCRP”). Under the terms of our agreement with HCRP, during the first royalty interest period of April 1, 2016 through March 31, 2025, HCRP is entitled to the first $3.0 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties earned in each year commencing on April 1, with any excess revenue being retained by us. Further, during the second royalty interest period beginning April 1, 2025 and ending on December 24, 2029, HCRP is entitled to the first $2.7 million and any cumulative remaining shortfall amount plus 15% of the next $1.0 million in royalties, with any excess revenue being retained by us. A shortfall occurs when, during an annual period ending on March 31 st, for the first royalty interest period of April 1, 2016 through March 31, 2025, royalty payments fall below $3.0 million; and $2.7 million for the second royalty interest period of April 1, 2025 and ending on December 24, 2029, excluding the period of April 1, 2028 through December 24, 2029. In the event there is a remaining cumulative remaining shortfall amount as of December 24, 2029, then, for so long as the Company continues to receive royalties from Daiichi Sankyo Company Limited (“Daiichi Sankyo”), the sum of those royalties will be paid to HCRP until the cumulative remaining shortfall amount has been paid in full.
Previous wording
In 2022, the Company accepted a grant of $3.5 million to perform research and development work for the Bill & Melinda Gates Foundation (the “BMGF Grant”). 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.
Current wording
In November 2022, we accepted a grant (the “BMGF Grant”) of $3.5 million to perform research and development work for the Bill & Melinda Gates Foundation and received $2.0 million in advance that was recorded as restricted cash and deferred revenue. We received an additional $1.5 million in July 2023 upon completion of certain milestones. We recognize revenue under research contracts only when a contract is executed and the contract price is fixed or determinable. Revenue from the BMGF Grant was recognized in the period during which the related costs were incurred and the related services rendered, as the applicable conditions under the contract were met. Costs of contract revenue were recorded as a component of operating expenses in the consolidated statements of operations and comprehensive loss. We fully recognized revenue from the BMGF Grant during the year ended December 31, 2023.
Previous wording
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 in 2022 since we now perform the majority of our manufacturing activities in-house. We have captured these external costs for each vaccine program. We do not allocate external costs incurred on preclinical research or process development to specific programs.
Current wording
We have incurred significant external costs for CROs that conduct clinical trials on our behalf. 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.
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 (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 years ended December 31 (in thousands):
Previous wording
The following table presents period-over-period changes in selected items in the consolidated statements of operations and comprehensive loss (in thousands, except percentages):
Current wording
The following table presents period-over-period changes in selected items in the consolidated statements of operations and comprehensive loss for years ended December 31 (in thousands, except percentages):
Previous wording
For the year ended December 31, 2023, non-cash royalty revenue related to sale of future royalties from Daiichi Sankyo was $3.9 million, compared to $0.1 million for the year ended December 31, 2022. A flu epidemic in Japan caused the increase in non-cash revenue in 2023. The Company continues to have non-cash royalty revenue as all royalties received in the year ended December 31, 2023 and 2022, were required to be paid to HCRP.
Current wording
For the year ended December 31, 2024, non-cash royalty revenue related to sale of future royalties from Daiichi Sankyo was $3.8 million, compared to $3.9 million for the year ended December 31, 2023. We continue to have non-cash royalty revenue as all royalties received in the years ended December 31, 2024 and 2023 were required to be paid to HCRP.
Previous wording
The Company recognized revenue from the BMGF Grant of $3.5 million and zero for the years ended December 31, 2023 and 2022, respectively.
Current wording
We recognized revenue from the BMGF Grant of zero and $3.5 million for the years ended December 31, 2024 and 2023, respectively.
Previous wording
For the year ended December 31, 2023, research and development expenses were $68.1 million, a decrease of $12.9 million, or 16%, compared to $81.1 million for the year ended December 31, 2022. The decrease was 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.
Current wording
For the year ended December 31, 2024, research and development expenses were $74.2 million, an increase of $6.1 million, or 9%, compared to $68.1 million for the year ended December 31, 2023. The increase was primarily due to increases in clinical trial expenses related to our COVID-19 vaccine candidate, an increase in manufacturing and preclinical expenses and facilities expenses, offset by a decrease in clinical trial expenses related to our norovirus vaccine candidate and a decrease in stock-based compensation expense and personnel-related costs.
Previous wording
For the year ended December 31, 2023, general and administrative expenses were $22.6 million, a decrease of $6.8 million, or 23%, compared to $29.4 million for the year ended December 31, 2022. The decrease was primarily due to decreases in legal and professional fees, litigation settlement costs and directors' and officers' insurance, partially offset by an increase in personnel stock-based costs.
Current wording
For the year ended December 31, 2024, general and administrative expenses were $20.8 million, a decrease of $1.8 million, or 8% compared to $22.6 million for the year ended December 31, 2023. The decrease was primarily due to a decrease in personnel-related costs, including stock-based compensation expenses, and directors’ and officers’ insurance costs, offset by increases in severance costs, recruiting costs and other professional fees.
Previous wording
The following table summarizes the period-over-period changes in our non-operating income for years ended December 31 (in thousands, except percentages):
Current wording
The following table summarizes the period-over-period changes in our non-operating (expense) income for years ended December 31 (in thousands, except percentages):
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 $1.4 million in 2023, from the $1.3 million in 2022, 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 $3.0 million for the year ended December 31, 2024, from the $1.4 million in 2023, due to an increase in non-cash royalty revenue payable to HCRP.
Previous wording
A significant portion of the provision for income taxes in the years ended December 31, 2023 and 2022, respectively, is foreign taxes payable on intercompany interest and foreign withholding tax on royalty revenue earned on sales of Inavir in Japan. Our foreign 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, and has declined in line with reductions in royalty revenue. In addition, we incurred charges for state income taxes in the United States.
Current wording
The provision for income taxes was $260,000 and $261,000 for the years ended December 31, 2024 and 2023, respectively. The tax charge relates to interest on an intercompany loan from a foreign subsidiary and a 5% withholding tax on royalty revenue earned on sales of Inavir in Japan, which is potentially recoverable as a foreign tax credit but expensed because we record a 100% valuation allowance against our deferred tax assets. The amount of income tax expense recorded is directly proportional to Inavir royalties, including the portion that we pass through to HCRP.
Previous wording
We are a clinical-stage biotechnology company with no product sales. 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.
Current wording
We are a clinical-stage biotechnology company with no product sales. Our primary source of financing is from the sale and issuance of common stock in public offerings as well as funding from HHS BARDA. In the past, we have also obtained funds from the issuance of common stock warrants, secured debt and preferred stock and from collaboration agreements.
Previous wording
On September 15, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “September 2021 ATM”), pursuant to which it may offer and sell, from time to time through sales agents, shares of its common stock having an aggregate offering price of up to $100 million. The Company filed a prospectus supplement with the SEC on September 16, 2021, and will pay sales commissions of up to 3.0% of gross proceeds from the sale of shares. As of December 31, 2023, there was approximately $77.4 million in net proceeds still available to us under the September 2021 ATM. Since December 31, 2023, the Company sold an additional 5,071,472 shares under the September 2021 ATM for gross proceeds net of commissions of $5.7 million through March 12, 2024.
Current wording
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 incurred direct expenses and paid sales commissions of up to 3.0% of gross proceeds from the sale of shares under the September 2021 ATM. In the year ended December 31, 2024, 7,719,641 shares were issued and sold under the September 2021 ATM for gross proceeds of $9.1 million, which, after deducting sales commissions and expenses incurred to date, resulted in net proceeds of $8.8 million. Effective October 18, 2024, the Company terminated the September 2021 ATM and discontinued all offers and sales of common stock thereunder.
Previous wording
Based on management's current plan, the Company expects to have enough cash runway into the fourth quarter of 2024. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, management’s plans include further reducing or delaying operating expenses. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these consolidated financial statements. The accompanying 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.
Current wording
Based on management’s current plan, we expect to have enough cash runway into the fourth quarter of 2025. 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. These conditions raise substantial doubt about our ability to continue as a going concern for a period of one year from the date of the issuance of these consolidated financial statements. The accompanying consolidated financial statements have been prepared assuming that we 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.
Previous wording
We experienced negative cash flow from operating activities for the years ended December 31, 2023, and 2022, in the amounts of $70.5 million, and $94.8 million, respectively. The cash used in operating activities for the year ended December 31, 2023, was due to cash used to fund a net loss of $82.5 million and an increase in working capital of $10.9 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, stock-based compensation and non-cash interest expense related to sale of future royalties, net of non-cash revenue related to sale of future royalties and amortization of discount on investments, net totaling $22.9 million. The cash used in operating activities for the year ended December 31, 2022, was due to cash used to fund a net loss of $107.8 million and an increase in working capital of $4.7 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, stock-based compensation, impairment of intangible assets and non-cash interest expense related to sale of future royalties, net of gain on remeasurement of future royalty liability, amortization of discount on investments, net and non-cash revenue related to sale of future royalties totaling $17.7 million.
Current wording
We experienced negative cash flow from operating activities for the years ended December 31, 2024, and 2023, in the amounts of $44.8 million, and $70.5 million, respectively. The cash used in operating activities for the year ended December 31, 2024, was due to cash used to fund a net loss of $66.9 million and an increase in working capital of $3.3 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, stock-based compensation and non-cash interest expense related to sale of future royalties, net of non-cash revenue related to sale of future royalties and amortization of discount on investments, net totaling $18.9 million. The cash used in operating activities for the year ended December 31, 2023, was due to cash used to fund a net loss of $82.5 million and an increase in working capital of $10.9 million, partially offset by adjustments for net non-cash income related to depreciation and amortization, stock-based compensation and non-cash interest expense related to sale of future royalties, net of non-cash revenue related to sale of future royalties and amortization of discount on investments, net totaling $22.9 million.
Previous wording
In 2023, we received $45.7 million from maturities of investments, net of purchases and used $1.8 million to purchase property and equipment, net of disposals. In 2022, we used $10.8 million to purchase investments, net of maturities and used $9.6 million to purchase property and equipment.
Current wording
In the year ended December 31, 2024, we used $20.8 million of cash to purchase investments, net of maturities, and used $0.6 million of cash to purchase property and equipment. In 2023, we received $45.7 million from maturities of investments, net of purchases and used $1.8 million to purchase property and equipment, net of disposals.
Previous wording
In 2023, we received $13.6 million from the issuance of common stock in a registered direct offering, $1.4 million from the sale of common stock under the September 2021 ATM and $0.6 million from the issuance of common stock under the employee stock purchase plan, partially offset by $0.4 million from common stock acquired to settle employee tax withholding liabilities. In 2022, we received $17.2 million from the sale of common stock under the September 2021 ATM and $0.2 million from the exercise of stock options.
Current wording
In the year ended December 31, 2024, we received net proceeds of $37.5 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, net proceeds of $9.9 million from the sale of our common stock under the 2024 Securities Purchase Agreement and $0.5 million from the issuance of common stock and treasury stock under the employee stock purchase plan, partially offset by $0.2 million from common stock acquired to settle employee tax withholding liabilities. In 2023, we received $13.6 million from the issuance of common stock in a registered direct offering, $1.4 million from the sale of common stock under the September 2021 ATM and $0.6 million from the issuance of common stock under the employee stock purchase plan, partially offset by $0.4 million from common stock acquired to settle employee tax withholding liabilities.
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 2023, 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 2024, a notional 10% decrease in expected term would have reduced the fair value and the related compensation expense by approximately 2.1%.
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 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 4.2%.
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 2024, a notional 10% decrease in expected volatility (from 129.1% to 116.2%) would have reduced the fair value and the related compensation expense by approximately 4.0%.
Previous wording
See the “Recent Accounting Pronouncements” in Note 2 to the Consolidated Financial Statements in Part II, Item 8 for information related to the issuance of new accounting standards in 2023, none of which have had, or are expected to have, a material impact on our consolidated financial statements.
Current wording
See the “Recent Accounting Pronouncements” in Note 2 to the Consolidated Financial Statements in Part II, Item 8 for information related to the issuance of new accounting standards in 2024, which are either not applicable to its operations or their adoption is not expected to have a material impact on our consolidated financial statements.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
We are not obligated to pay HCRP any royalty payment beyond what we are paid by Daiichi Sankyo. The cumulative remaining shortfall amount is the aggregate amount of the shortfall for each annual period, which was $6.0 million as of December 31, 2024. Even though we do not currently 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.