Aligos Therapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 10, 2025.
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FY2024 · Filed Mar 10, 2025
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Notes to Consolidated Financial Statements
financial statements
Unless otherwise indicated, financial information except share and per share data, including dollar values stated in the text of the notes to financial statements, is expressed in thousands of dollars.
- Organization
Description of business
Aligos Therapeutics, Inc. (Aligos-US) was incorporated in the state of Delaware on February 5, 2018 (inception). On September 10, 2018, the Company formed Aligos Belgium BVBA (the Subsidiary or Aligos-Belgium). On March 30, 2020, the Company formed as a wholly owned subsidiary, Aligos Australia Pty LTD (Aligos-Australia), a proprietary limited company. On May 18, 2021, the Company formed as a wholly owned subsidiary, Aligos Therapeutics (Shanghai) Co. Ltd. (Aligos-Shanghai) and together with Aligos-US, Aligos-Belgium, and Aligos-Australia being the Company or Aligos.
Aligos is a clinical-stage biotechnology company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, including in the areas of chronic hepatitis B (CHB), metabolic dysfunction associated steatohepatitis (MASH), and coronavirus (e.g., SARS-CoV-2 and related infections).
The Company is devoting substantially all of its efforts to the research and development of its drug candidates. The Company has not generated any product revenue to date. The Company is also subject to a number of risks similar to other companies in the biotechnology industry, including the uncertainty of success of its preclinical studies and clinical trials, regulatory approval of drug candidates, uncertainty of market acceptance of products, competition from substitute products and larger companies, the need to obtain additional financing, compliance with government regulations, protection of proprietary technology, dependence on third-parties, product liability, and dependence on key individuals.
Liquidity
The Company has incurred losses and negative cash flows from operations since its inception. As of December 31, 2024 and 2023, the Company had an accumulated deficit of approximately$618.0 million and$486.8 million, respectively. Management expects to continue to incur additional substantial losses in the foreseeable future as a result of expanded research and development activities.
As of December 31, 2024, the Company has cash, cash equivalent and investments of approximately$56.9 million, which is available to fund future operations. The Company expects to continue to spend substantial amounts to continue the nonclinical and clinical development of its current and future programs. If the Company is able to gain marketing approval for drug candidates that are being developed, it will require significant additional amounts of cash in order to launch and commercialize such drug candidates. In addition, other unanticipated costs may arise. Because the design and outcome of the Company’s planned and anticipated clinical trials is highly uncertain, the Company cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any drug candidate the Company may develop.
The Company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. Based on the Company’s research and development plans, it is expected that the Company’s existing cash, cash equivalents and investments, inclusive of the cash received from the PIPE financing in February 2025, will enable the Company to fund its operations for at least 12 months following the date the consolidated financial statements are issued. However, the Company’s operating plan may change as a result of many factors currently unknown, and the Company may need to seek additional funds sooner than planned. Moreover, it is particularly difficult to estimate with certainty the Company’s future expenses given the dynamic nature of its business, and the macro-economic environment generally.
The Company’s ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond its control. If additional funds are not available to the Company when needed, on terms that are acceptable to the Company, or at all, the Company may be required to: delay, limit, reduce or terminate nonclinical studies, clinical trials or other research and development activities or eliminate one or more of its development programs altogether; or delay, limit, reduce or terminate its efforts to establish manufacturing and sales and marketing capabilities or other activities that may be necessary to commercialize any future approved products, or reduce the Company’s flexibility in developing or maintaining its sales and marketing strategy.
- Summary of significant accounting policies
The accompanying consolidated financial statements have been prepared on a basis that contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
Risks and uncertainties
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. As a result, the Company is unable to predict the timing or amount of increased expenses or when or if the Company will be able to achieve or maintain profitability. Drug candidates currently under development will require significant additional research and development efforts, including extensive nonclinical and clinical testing and regulatory approval.
Moreover, it is particularly difficult to estimate with certainty the Company’s future expenses given the dynamic nature of its business, and the macro-economic environment generally.
Basis of presentation
The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative U.S. GAAP included in the Accounting Standards Codification (ASC), and Accounting Standards Update (ASU) issued by the Financial Accounting Standards Board (the FASB).
Certain amount previously reported in 2023 Consolidated Statements of Operations and Comprehensive Loss has been reclassified to conform the 2024 presentation, with respect to the separate presentation of changes in fair value of common warrants in the amount of $2.2 million, previously included in interest and other income, net. The reclassification had no impact on our net loss.
Principles of consolidation
The accompanying consolidated financial statements include Aligos-US and its wholly owned subsidiaries Aligos-Belgium, Aligos-Australia and Aligos-Shanghai. All intercompany balances and transactions have been eliminated.
Use of estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Accounting estimates and judgments are inherently uncertain, and the actual results could differ from these estimates.
Foreign currency
The Company’s foreign subsidiaries use the U.S. dollar as their functional currency, and they initially measure the foreign currency denominated assets and liabilities at the transaction date. Monetary assets and liabilities are then re-measured at exchange rates in effect at the end of each period, and non-monetary assets and liabilities are converted at historical rates. A re-measurement loss was recognized during the year ended December 31, 2024 of$3.4 thousand, and a re-measurement loss was recognized during the year ended December 31, 2023 of$45.7 thousand, and are reflected within interest and other income, net on the Consolidated Statements of Operations and Comprehensive Loss.
Segment information
The Company hasone reportable segment which is focused on discovering and developing drug candidates in both liver and viral diseases. The Company’s Chairman, President and Chief Executive Officer, who is thechief operating decision maker (CODM), assesses segment performance and decides how to allocate resources based on net loss that is also reported on the Consolidated Statements of Operations and Comprehensive Loss. See Note 17, Segment disclosure, for additional information.
Cash equivalents
The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents.
Restricted cash
As of December 31, 2024 and 2023, the restricted cash balance was$0.1 million and$0.1 million, respectively, and was used primarily to secure letters of credit in relation to the Company’s operating leases and deposits on rental assets (Note 6), as well as employee withholdings for the employee stock purchase plan.
Short-term investments
The Company generally invests its excess cash in money market funds and investment grade short-to-intermediate-term fixed income securities. Such investments are included in cash, cash equivalents and investments on the Consolidated Balance Sheets.
The Company determines the appropriate classification of securities at the time of purchase and re-evaluates such designation as of each balance sheet date. Available-for-sale debt securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale securities are reported as a separate component of stockholders’ (deficit) equity. Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. The cost of securities sold is determined on a specific identification basis, and realized gains and losses are included in interest and other income, net within the Consolidated Statements of Operations and Comprehensive Loss.
The Company assesses available-for-sale debt securities on a quarterly basis to see whether any unrealized loss is due to credit-related factors. Factors considered in determining whether an impairment is credit-related include the extent to which the investment’s fair value is less than its cost basis, declines in published credit ratings, changes in interest rates, and any other adverse factors related to the security. If it is determined that a credit-related impairment exists, the Company will measure the credit loss based on a discounted cash flow model. Credit-related impairments on available-for-sale debt securities are recognized as an allowance for credit losses with a corresponding adjustment to other income, net in the Company’s consolidated statement of operations. The unrealized loss position that is not credit-related is recorded, net of any related tax effects, in other comprehensive income until realized. There wereno credit-related losses recognized for the periods presented
Accrued Interest Receivable
Accrued interest receivable related to the Company’s available-for-sale debt securities is presented within prepaid expenses and other current assets on the Company’s consolidated balance sheets. The Company has elected to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivables associated with its available-for-sale debt securities.
Concentrations of credit risk and significant suppliers
The Company has no significant off-balance sheet risk, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, restricted cash and investments. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company generally invests its excess capital in money market funds, U.S. treasury bonds, U.S. treasury bills and certificates of deposit that are subject to minimal credit and market risks.
The Company is dependent on various third parties to manufacture compounds for the Company to conduct research and studies for its programs. These programs would be adversely delayed by a significant interruption in the supply of active pharmaceutical ingredients.
Accounting for Government Grants
In 2022, the Company was awarded agrantof $1.1 million by the National Institutes of Health (NIH) for research to target coronaviruses. The grant is for multiple years with the amount updated after each year of progress through 2025, subject to the annual reapplication and approval by the NIH. In 2023, the approved grant awarded was an additional $1.4 million. In 2024, the approved grant awarded was an additional $1.5 million.
In 2023, the Company wasawardeda contract of $8.5 million by the National Institute of Allergies and Infectious Diseases (NIAID) for research to target coronaviruses. In March 2024, the Company entered into an amendment to the above contract and wasawarded an additional $1.3 million, making the total contract value $9.8 million. The contract will end in early 2026.
U.S. GAAP does not contain authoritative accounting standards for grants or contracts provided by governmental entities to a for-profit entity. Absent authoritative accounting standards, interpretative guidance issued and commonly applied by financial statement preparers allows for the selection of accounting policies amongst acceptable alternatives. The Company determined it most appropriate to account for grants by analogy to International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance. Under this model, reimbursements the Company receives from the U.S. government for qualifying expenditures under the NIH grant will be recognized in earnings as a reduction to research and development expense when there is reasonable assurance that the Company will receive the grant. IAS 20 does not define “reasonable assurance”; however, the Company analogized this to “probable” as defined in FASB ASC 450-20-20 under U.S. GAAP, which is the definition the Company has applied. The grants and contracts will be recognized in earnings as a reduction of the related research and development (R&D) expenses.
During the year ended December 31, 2024, $2.8 million was recognized as a reduction to R&D expenses. During the year ended December 31, 2023, $1.6 million was recognized as a reduction to R&D expenses.
Common Warrants liability
The Company accounts for certain warrants as liabilities at fair value and adjusts the instruments to fair value at each reporting period. The Company determined that its outstanding warrants are freestanding derivative instruments. The warrants are subject to remeasurement at each balance sheet date until exercised, and any change in fair value is recognized in the Consolidated Statements of Operations and Comprehensive Loss. The fair value of the warrants issued by the Company has been estimated and is remeasured at the end of each reporting period using a Black-Scholes option pricing model.
Leases
The Company determines at the inception of the lease if an arrangement is a lease. Operating leases are included in operating lease right-of-use (ROU) assets and operating lease liabilities in the Consolidated Balance Sheets. Finance leases are included in property and equipment and finance lease liabilities in the Consolidated Balance Sheets.
ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. When the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement dates in determining the present value of lease payments. The Company uses the implicit rate when readily determinable. The operating lease ROU assets also include any lease payments made and excludes lease incentives when paid by the Company or on the Company’s behalf. The Company’s lease terms may include the period covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for operating leases is recognized on a straight-line basis over the lease term.
The Company has lease agreements with lease and non-lease components. The Company elected to not separate lease and non-lease components for all of its building leases. For vehicle leases, lease and non-lease components are accounted for separately. The Company also made an accounting policy election to recognize lease expense for leases with a term of 12 months or less on a straight-line basis over the lease term and not recognize ROU assets or lease liabilities for such leases.
Property and equipment
Property and equipment is stated at cost less accumulated depreciation, and is depreciated using the straight-line method over the estimated useful life of the asset, which are as follows:
| Lab equipment | 3 years |
|---|---|
| Computer equipment | 3 years |
| Furniture and office equipment | 3-8 years |
| Vehicles | 4 years |
| Leasehold improvements | Shorter of the useful life orremaining lease term |
Expenditures for repairs and maintenance of assets are charged to expense as incurred. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in loss from operations.
Impairment of long-lived assets
The Company regularly reviews the carrying amount of its property, equipment, other long-lived assets and intangible assets to determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. If indications of impairment exist, projected future undiscounted cash flows associated with the asset are compared to the carrying amount to determine whether the asset’s value is recoverable. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. During the year ended December 31, 2023, the Company vacated certain leased office space and, as a result, the Company recorded an impairment charge against right of use assets of $0.7 million, recorded in the Consolidated Statements of Operations and Comprehensive Loss as general and administrative (G&A) expenses. No other impairment charges were recorded during the years ended December 31, 2024 or 2023.
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, stock-based compensation and benefits, facilities costs, depreciation, and third-party license fees. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized.
In-process research and development (IPR&D) expense represents the costs to acquire technologies to be used in research and development that have not reached technological feasibility or have no alternative future uses and thus are expensed as incurred. IPR&D expense also includes upfront license fees and milestones paid to collaborators for technologies with no alternative use.
Collaborative arrangements
The Company enters into collaboration arrangements with pharmaceutical and other partners, under which the Company may grant licenses to its collaboration partners to research and develop potential drug candidates. Consideration under these contracts may include an upfront payment, development, regulatory, sales and other milestone payments. Contractual payments received for research and development activities performed are recognized on a gross basis in revenue from collaboration arrangements.
The Company may also perform research and development activities under the collaboration agreements where the Company may be granted licenses from its collaboration partners. Contractual payments to the other party in collaboration agreements and costs incurred by the Company are recognized on a gross basis in research and development expenses. Development and regulatory milestones payments to collaboration partners are recorded as research and development costs when such payments become probable. Royalties and sales-based milestone payments are recorded when the related sales occur.
When the Company enters into collaboration arrangements, the Company assesses whether the arrangement falls within the scope of ASC 808, Collaborative Arrangements (ASC 808) based on whether the arrangement involves joint operating activities and whether both parties would be active participants and would be exposed to significant risks and rewards of the arrangement. To the extent that the arrangement falls within the scope of ASC 808, the Company assesses whether the payments between the parties fall within the scope of other accounting literature such as ASC 606, Revenue from Contracts with Customers (ASC 606).
Revenue from contracts with customers
The Company enters into revenue arrangements with certain partners. Consideration under these contracts may include an upfront payment, development, regulatory, sales and other milestone payments. Contractual payments received for research and development activities performed are recognized on a gross basis in Revenue from Customers.
The Company may also perform research and development activities under the revenue agreements where the Company may be granted licenses from its partners. Contractual payments to the other party in revenue agreements and costs incurred by the Company are recognized on a gross basis in research and development expenses. For arrangements that include royalties and sales-based milestone payments, the license is deemed to be the predominant item to which such payments relate and the Company recognizes revenue at the later of when the related sales occur or when the performance obligation to which the royalty has been allocated has been satisfied.
When the Company enters into revenue arrangements, the Company assesses whether the arrangement first falls within the scope of ASC 808, Collaborative Arrangements (ASC 808) based on whether the arrangement involves joint operating activities and whether both parties would be active participants and would be exposed to significant risks and rewards of the arrangement. If the arrangement does not fall into this literature, the Company then looks to ASC 606, Revenue from Contracts with Customers (ASC 606) to see whether the partner is considered a customer.
Fair value measurements
Certain assets and liabilities of the Company are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
Level 1—Quoted prices in active markets for identical assets or liabilities.
Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Stock-based compensation
The Company’s stock-based awards consist of restricted stock awards and stock options. For stock-based awards issued to employees and nonemployees, the Company measures the estimated fair value of the stock-based awards on the date of grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective awards. The Company records expense for awards with service-based vesting using the straight-line method. The Company accounts for forfeitures as they occur.
The Company classifies stock-based compensation expense in its Consolidated Statements of Operations and Comprehensive Loss in the same manner in which the award recipient’s cash compensation costs are classified.
The fair value of each restricted stock award is the closing price of the Company’s common stock on the date of grant. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of a number of assumptions including the fair value of the common stock, expected volatility, risk-free interest rate, expected dividends, and expected term of the option.
The Company determined the expected stock volatility using a weighted-average of the historical volatility of a group of guideline companies that issued options with substantially similar terms, and expects to continue to do so until such time as the Company has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the simplified method for awards that qualify as “plain-vanilla” options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. The Company hasnot paid, and does not anticipate paying, cash dividends on its common stock; therefore, the expected dividend yield is assumed to bezero.
The fair value of the Company’s 2020 Employee Stock Purchase Plan (the ESPP)is determined on the date the offering period begins using a Black-Scholes option-pricing model and similar assumptions for stock options as described above.
Income taxes
Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established.
The Company accounts for uncertain tax positions recognized in the consolidated financial statements by prescribing a more-likely-than-not threshold for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related interest and penalties.
Comprehensive Loss
Comprehensive loss comprises net loss and other comprehensive loss. Other comprehensive (loss) income consists of foreign currency translation adjustments, unrealized gain on marketable securities and unrealized (loss) gain on pension plans.
Net loss per share
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. The weighted-average number of shares of common stock outstanding includes the shares subject to the pre-funded warrants as per ASC 260, shares issuable for little or no cash consideration upon the satisfaction of certain conditions, shall be considered outstanding common shares.
Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, stock options, common stock subject to repurchase related to early exercise of stock options, unvested restricted stock subject to repurchase, common stock warrants and convertible notes are considered to be potentially dilutive securities.
Accordingly, in periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
Benefit plans
The Company has established a defined contribution savings plan for its employees in Aligos-US under Section 401(k) of the Internal Revenue Code, and a defined benefits plan for its employees in Aligos-Belgium.
The Company uses the standard method for the recognition of the actuarial results as described in ASC 715. This means application of a 10%corridor and amortization over the expected average remaining working lives of theemployees. The plan contains benefits to the plan participant on the normal plan retirement date and benefits to the partner after death of the plan participant. This plan is recognized under ASC 715.
Reverse Stock Split
In June 2024, the Company’s stockholders approved a reverse stock split of its authorized, issued and outstanding voting and non-voting common stock at a range of ratios between 1-for-5 to 1-for-30, and the Company’s board of directors subsequently approved the implementation of the reverse stock split at a ratio of 1-for-25 (the Reverse Stock Split). The Reverse Stock Split was effective as of August 19, 2024.
As of the effective time of the Reverse Stock Split, every 25 issued and outstanding shares of the Company’s common stock was automatically reclassified into one issued and outstanding share of the Company’s common stock. This reduced the number of shares outstanding from 79.9 million shares to 3.3 million shares. The Reverse Stock Split did not affect the par value of the common stock. No fractional shares of common stock were issued in connection with the Reverse Stock Split and all fractional shares were rounded down to the nearest whole share with respect to outstanding shares of common stock. Any holders of common stock who would have otherwise received a fractional share of common stock pursuant to the Reverse Stock Split, received cash in lieu of the fractional share. All prior period share and per share amounts of the Company's common stock presented have been retroactively adjusted to reflect the 1-for-25 Reverse Stock Split.
Recently issued accounting standards
In November 2024, the FASB issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The standard is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027. Early adoption is permitted. The Company is evaluating the potential impact of this standard on its consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09 - Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The standard is effective for fiscal years beginning after December 15, 2024. The Company is evaluating the potential impact of this standard on its consolidated financial statements.
- Property and equipment
The components of property and equipment were as follows as of December 31, 2024 and 2023:
| December 31,2024 | December 31,2023 | |
|---|---|---|
| Leasehold improvements | $6,101 | $6,101 |
| Lab equipment | 5,975 | 5,830 |
| Computer equipment | 1,051 | 1,051 |
| Furniture and office equipment | 732 | 732 |
| Vehicles and equipment | 281 | 296 |
| Asset under construction | 4 | 4 |
| Total, at cost | 14,144 | 14,014 |
| Accumulated depreciation | (11,782) | (10,755) |
| Total, net | $2,362 | $3,259 |
During the years ended December 31, 2024 and 2023, depreciation expense was$1.0 million and$1.6 million, respectively. Finance leases for vehicles and lab equipment are also included in property and equipment on the Consolidated Balance Sheets (Note 6).
- Short-term investments
As of December 31, 2024, amortized cost, gross unrealized gains and losses, and estimated fair values of total fixed-maturity securities were as follows:
| Gross · Gross | |||||
|---|---|---|---|---|---|
| Amortized · Unrealized · Unrealized · Estimated | |||||
| Cost · Gain · Loss · Fair Value | |||||
| Available-for-sale securities: | |||||
| U.S. Treasury bonds | $19,933 | $9 | $ | - | $19,942 |
No short-term investments are in an unrealized loss position. The Company hadno available-for-sale securities as of December 31, 2023.
Changes in fair value are related to changes in market interest rates. The Company expects to collect all contractual principal and interest payments and does not intend to sell the investments before recovery of their amortized cost bases. As of December 31, 2024, all investments had a remaining maturity of less thanone year.
The Company recorded interest income of$1.7 million and$4.3 million, respectively, during the years ended December 31, 2024 and 2023, as a component of interest and other income, net on the Company’s Consolidated Statement of Operations and Comprehensive Loss.
- Accrued liabilities
Accrued liabilities consisted of the following as of December 31:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Accrued R&D expenses | $5,029 | $6,633 |
| Accrued compensation | 6,387 | 6,673 |
| Other | 2,670 | 3,025 |
| Accrued payables | 1,471 | 511 |
| Total | $15,557 | $16,842 |
- Leases
The Company has operating and finance leases for corporate offices, research and development facilities, and certain vehicles and lab equipment. These leases have remaining lease terms ofthree tofive years, some of which include options to extend the leases forfive toeight years. The Company has determined that it is not reasonably certain to exercise the options under any leases. The lease of research and development facilities includes costs for utilities and common area maintenance which have been included in the calculation of lease payments. Differences between lease payments as measured at lease inception and variations in monthly payments will be recognized as operating expenses in the period in which the obligation is incurred.
Maturities of lease liabilities as of December 31, 2024, were as follows:
| OperatingLease · FinanceLease | ||
|---|---|---|
| Year ending December 31: | ||
| 2025 | $3,671 | $63 |
| 2026 | 3,792 | 42 |
| 2027 | 1,434 | - |
| 2028 | 155 | - |
| 2029 | - | - |
| Thereafter | - | - |
| 9,052 | 105 | |
| Less: imputed interest | (835) | 53 |
| Present value of lease liabilities | 8,217 | 158 |
| Less: current portion | (3,422) | (36) |
| Lease liabilities, net of current portion | $4,795 | $122 |
The components of lease expense were as follows for the years ended December 31, 2024 and 2023:
| 2024 | 2023 | |
|---|---|---|
| Operating lease cost | $1,931 | $2,321 |
| Finance lease cost: | ||
| Amortization of right-of-use assets | $56 | $84 |
| Interest on lease liabilities | 7 | 11 |
| Total finance lease cost | $63 | $95 |
The Company made payments of$3.6 million and$3.4 million during the years ended December 31, 2024 and 2023, respectively, which are included as cash flow from operations on the Consolidated Statements of Cash Flows.
As of December 31, 2024 and 2023,$0.6 million and$0.7 million of finance lease ROU assets, respectively, were presented as part of property and equipment on the Consolidated Balance Sheets with accumulated amortization of$0.5 million and $0.4 million, respectively.
Additional information related to the Company’s leases was as follows as of December 31:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Operating Lease: | ||
| Weighted-average remaining lease term (years) | 1.78 | 3.38 |
| Weighted-average discount rate | 8.90% | 7.94% |
| Finance Lease: | ||
| Weighted-average remaining lease term (years) | 1.67 | 2.67 |
| Weighted-average discount rate | 3.59% | 5.57% |
- Capital stock
Common stock
On October 20, 2020, the Company amended its certificate of incorporation to increase the total shares of common stock authorized for issuance to 12,800,000 and decrease the total shares of preferred stock authorized for issuance to 10,000,000 with a par value of $0.0001 per share.12,000,000 shares of the common stock were designated as “Voting Common Stock” and 800,000 shares of the common stock were designated as “Non-Voting Common Stock”.
On June 27, 2024, the Company amended its certificate of incorporation to increase the total shares of voting common stock authorized for issuance from 12,000,000 to 20,000,000.
The holders of shares of voting common stock are entitled toone vote for each share of common stock at all meetings of stockholders.
Preferred stock
As of December 31, 2024 and 2023, there were 10,000,000 shares of preferred stock authorized andno preferred stock issued.
- Common Warrants and Pre-Funded Warrants
In October 2023, the Company completed a private investment in public equity offering and entered into a securities purchase agreement (the Securities Purchase Agreement) with certain institutional and accredited investors, pursuant to which the Company agreed to offer, issue and sell to these investors 1,257,168 shares of common stock, par value $0.0001 per share (the Common Stock), pre-funded warrants to purchase an aggregate of 3,242,018 shares of Common Stock (the Pre-Funded Warrants), and warrants to purchase an aggregate of 2,249,680 shares of Common Stock (the Common Warrants, and together with the Pre-Funded Warrants, the Warrants). Each Pre-Funded Warrant has an exercise price of $0.0025 per share of common stock, was immediately exercisable and is exercisable until exercised in full. Each accompanying Common Warrant has an exercise price of $18.92 per share of common stock, is immediately exercisable and will expire on October 25, 2030. The closing of the offering occurred on October 25, 2023. The Company received gross proceeds of $92.1 million, and after deducting the placement agent fees and expenses and offering costs, net proceeds were $86.2 million.
The Company measured the fair value of the Common Stock and the Pre-Funded Warrants based on the $18.92 per share purchase price stated in the Securities Purchase Agreement. The Company measured the fair value of the Common Warrants using the Black-Scholes option pricing model.
The Company used the with-and-without method to allocate the net proceeds received from the sale of the Common Stock, the Pre-Funded Warrants, and the Common Warrants on the Consolidated Balance Sheets as follows:
| Common Stock | $18,641 |
|---|---|
| Pre-Funded Warrants | 48,079 |
| Common Warrants | 25,427 |
| Total net proceeds | $92,147 |
The following table summarizes information about shares issuable under the Pre-Funded Warrants outstanding at December 31, 2024 and 2023:
| Pre-funded warrant shares outstanding | 2024 | 2023 |
|---|---|---|
| Outstanding at January 1 | 3,242,018 | - |
| Issued | - | 3,242,018 |
| Exercised | (800,613) | - |
| Outstanding at December 31 | 2,441,405 | 3,242,018 |
| Exercisable at December 31 | 2,441,405 | 3,242,018 |
The following table sets forth a summary of the activities of the Company’s warrant liability, which represents a recurring measurement that is classified with Level 3 of the fair value hierarchy:
| 2024 · 2023 | |||
|---|---|---|---|
| Beginning liability as of January 1 | $27,596 | $ | - |
| Common warrants issued | - | 25,427 | |
| Common warrants exercised | (1,361) | - | |
| Change in fair value of liability | 46,132 | 2,169 | |
| Ending liability as of December 31 | $72,367 | $27,596 | |
The fair value of the Common Warrants was measured using the Black Scholes option pricing model and will be remeasured each reporting period, and the change in fair value will be recorded in earnings. The assumptions that the Company used to determine the fair value at issuance and the reporting date of the Common Warrants granted to participants were as follows:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Expected term (in years) | 5.83 | 6.83 |
| Risk-free interest rate | 4.43% | 3.88% |
| Dividend yield | - | - |
| Volatility | 84.62% | 82.80% |
The following table summarizes information about shares issuable under the Common Warrants outstanding at December 31, 2024 and 2023:
| Common warrant shares outstanding | 2024 | 2023 |
|---|---|---|
| Outstanding at January 1 | 2,249,680 | - |
| Issued | - | 2,249,680 |
| Exercised | (48,822) | - |
| Outstanding at December 31 | 2,200,858 | 2,249,680 |
| Exercisable at December 31 | 2,200,858 | 2,249,680 |
- Stock-based compensation
2018 Equity incentive plan
Following the Company's IPO in October 2020, the remaining shares from the 2018 Equity Incentive Plan (the 2018 Plan) were made available for issuance under the 2020 Incentive Award Plan (the 2020 Plan). As of December 31, 2024, there are 58,023 options outstanding under the 2018 Plan and the Company had granted 131,086 options to employees under the 2018 Plan.
2020 Incentive award plan
The Company adopted the 2020 Plan effective October 15, 2020. The 2020 Plan provides for a variety of stock-based compensation awards, including stock options, stock appreciation rights, or SARs, restricted stock awards, restricted stock unit awards, performance bonus awards, performance stock unit awards, dividend equivalents, or other stock or cash-based awards. The Company has granted 778,025 shares subject to awards as of December 31, 2024 with 116,859 remaining available for future grant.
Following the effectiveness of the 2020 Plan, the Company will not make any further grants under the 2018 Plan. However, the 2018 Plan will continue to govern the terms and conditions of the outstanding awards granted under this plan. Shares of common stock subject to awards granted under the 2018 Plan that are forfeited or lapse unexercised and which following the effective date of the 2020 Plan are not issued under the 2018 Plan will be available for issuance under the 2020 Plan.
2024 Employment inducement award plan
The Company adopted the 2024 Employment Inducement Award Plan (the 2024 Plan) in September 2024 as an inducement material to entering employment in accordance with Nasdaq Listing Rule 5635(c)(4). The 2024 Plan is used exclusively for the grant of equity awards to individuals who were not previously employed by the Company. The 2024 Plan provides for issuance of non-qualified stock options only. The Company has granted 104,000 shares subject to awards as of December 31,2024 with 496,000 remaining available for future grant.
2020 Employee stock purchase plan
The Company adopted the 2020 Employee Stock Purchase Plan (the 2020 ESPP) effective on October 15, 2020. The 2020 ESPP enables eligible employees of the Company to purchase shares of common stock at a discount to fair market value. The Company has initially reserved for issuance 14,756 shares of common stock pursuant to the 2020 ESPP. As of December 31,2024,72,561 grants of awards under this plan have been made.
During the year ended December 31, 2024 and 2023, the Company's 2020 ESPP compensation expense was$0.5 million and$0.9 million, respectively. The assumptions that the Company used to determine the grant-date fair value of shares granted to participants were as follows, disclosed on a grant date basis:
| 2024 | 2023 | |
|---|---|---|
| Expected term (in years) | 0.5 - 2.0 years | 0.5 - 2.0 years |
| Risk-free interest rate | 2.58% - 5.38% | 2.07% - 5.38% |
| Dividend yield | - | - |
| Volatility | 50.36% - 73.67% | 50.36% - 64.26% |
| Weighted-average estimated fair value of purchase rights | $4.00 - $15.14 | $4.00 - $60.68 |
Stock options
The exercise price for incentive stock options is at least 100% of the fair market value on the date of grant for stockholders owning less than 10% of the voting power of all classes of stock, or at least 110% of the fair market value for stockholders owning more than 10% of the voting power of all classes of stock. Options generally expire in 10 years and vest over periods determined by the Board, generally 48 months. Certain stock options referred to as “early exercise stock options” permit the holders to exercise the option in whole or in part prior to the full vesting of the option in exchange for unvested shares of Restricted Stock with respect to any unvested portion of the option so exercised.
During the years ended December 31, 2024 and December 31, 2023, the Company’s stock option compensation expense was approximately$7.9 million and $11.8 million, respectively, and there wasno recognized tax benefit in either year. As of December 31,2024, unrecognized stock-based compensation expense related to stock options was$5.9 million, to be recognized over a weighted-average period of 2.63 years.
The assumptions that the Company used to determine the grant-date fair value of stock options granted to Participants were as follows, presented on a weighted-average basis:
| 2024 | 2023 | |
|---|---|---|
| Expected term (in years) | 5.94 | 6.00 |
| Risk-free interest rate | 3.98% | 3.83% |
| Dividend yield | - | - |
| Volatility | 87.35% | 76.65% |
Stock option activity during the year ended December 31,2024 and 2023 was as follows:
| Sharessubjectto options · Weighted-averageexerciseprice · Weighted-averageremainingcontractualterm (years) · AggregateIntrinsicValue (in thousands) | |||||
|---|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 414,898 | $159.46 | 6.90 | $ | - |
| Granted | 359,135 | $15.92 | |||
| Replacement options from Exchange | 76,147 | $24.00 | |||
| Exercised | — | $— | $— | ||
| Forfeited or Expired | (67,340) | $159.09 | |||
| Cancelled options from Exchange | (155,155) | $260.63 | |||
| Outstanding as of December 31, 2024 | 627,685 | $35.93 | 8.50 | $10,611 | |
| Options vested and expected to vest as of December 31, 2024 | 627,685 | $35.93 | 8.50 | $10,611 | |
| Options vested and exercisable as of December 31, 2024 | 172,072 | $80.39 | 6.37 | $944 | |
The weighted-average grant date fair value of stock options granted was$12.88 per share during the year ended December 31, 2024. The weighted-average grant date fair value of stock options granted was$20.67 per share during the year ended December 31, 2023. The total intrinsic value of stock options exercised during the years ended December 31, 2024 and 2023 were not material.
During the years ended December 31, 2024 and 2023 the Company did not issue shares for unvested stock options. As of December 31, 2024 and 2023, there wereno shares of Common Stock held by employees subject to repurchase.
Restricted stock awards
The Company may grant restricted stock purchase awards to the Participants to purchase restricted stock under the Company’s Plan, which are subject to vesting conditions. The purchase prices of the restricted stock are determined by the Board. The Company has a right to repurchase the shares if the Participant’s service period is not fulfilled or upon termination of service at the original per share issuance price. The right of repurchase lapses over a service period which is typically four years with 25% vesting on the first anniversary of the vesting commencement date and 1/48 each month thereafter.
Before the adoption of the Company’s Plan, the Company granted 20,118 restricted stock awards to employees and founders. These restricted stock awards have similar characteristics to the restricted stock awards granted under the Company’s Plan, other than the right of repurchase, which typically lapses over three years with 33% vesting on the first anniversary of the vesting commencement date and 1/36 each month thereafter.
During the years ended December 31, 2024 and 2023, the Company recorded a total stock-based compensation expense of$73.0 thousand and$31.0 thousand, respectively, related to the restricted stock awards. During the years ended December 31, 2024 and 2023, total fair value of restricted stock awards vested was $0.1 million andzero, respectively. The number of restricted stock awards vested includes shares of common stock that the Company withheld on behalf of employees or sold to cover to satisfy the minimum statutory tax withholding requirements. As of December 31, 2024, there was$0.1 million unrecognized stock-based compensation costs related to outstanding unvested restricted stock awards that are expected to vest over 3.27 years.
The following table summarizes the Company’s restricted common stock activity for years ended December 31,2024 and 2023:
| Numberof Awards | Weighted-AverageGrant DateFair Value | AggregateFair Value(in thousands) | |
|---|---|---|---|
| Issued and unvested as of December 31, 2023 | 5,362 | 21.00 | 113 |
| Granted | 4,241 | 14.99 | 64 |
| Vested and released | (4,874) | 21.17 | (103) |
| Issued and unvested as of December 31, 2024 | 4,729 | $15.44 | $74 |
Stock-based compensation expense was allocated as follows for the years ended December 31,2024 and December 31, 2023:
| Year Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Research and development | $4,842 | $6,843 |
| General and administrative | 3,610 | 5,809 |
| Total | $8,452 | $12,652 |
- Fair value measurements
The following tables present the fair value of the Company’s financial instruments that are measured or disclosed at fair value on a recurring basis:
| Level 1 · Level 2 · Level 3 | |||||
|---|---|---|---|---|---|
| Assets: | |||||
| Cash equivalents | $36,997 | $ | - | $ | - |
| Available for sale securities | 19,942 | - | - | ||
| Liabilities: | |||||
| Warrant liability | - | - | (72,367) | ||
| $56,939 | $ | - | $(72,367) | ||
| Level 1 · Level 2 · Level 3 | |||||
| Assets: | |||||
| Cash equivalents | $135,704 | $ | - | $ | - |
| Liabilities: | |||||
| Warrant liability | - | - | (27,596) | ||
| $135,704 | $ | - | $(27,596) | ||
- License and collaboration agreements
Agreements with Merck
In December 2020, the Company and Merck Sharp & Dohme Corp. (Merck), a subsidiary of Merck & Co., Inc., entered into an exclusive License and Research Collaboration Agreement (Original Agreement) under which Merck and the Company agreed to apply the Company’s oligonucleotide platform technology to discover, research, optimizeand develop oligonucleotides directed against a MASH target and up to one additional liver-targeted cardiometabolic and/or fibrosis target. Under the terms of the Original Agreement, the Company received an upfront payment of $12 million from Merck. With respect to the collaboration target, the Company is eligible to receive up to $458.0 million in development and commercialization milestones as well as tiered royalties on net sales of licensed products.
In January 2022, the Company and Merck entered into an amendment to the exclusive License and Research Collaboration Agreement (the First Amendment, together with the Original Agreement, the Expanded Arrangement). As a result of the First Amendment, our collaboration with Merck was expanded to include our grant of rights to Merck of an early-stage program with respect to a second undisclosed MASH target, on which the Company had previously been working independently. In addition, under this Expanded Arrangement, Merck has the ability to add an additional third target of interest in the cardiometabolic/fibrosis space to the collaboration. This right to add an additional third target expired in January 2023. Under the Expanded Arrangement, the Company received an upfront payment of $15 million from Merck for our grant of rights to the program directed at a second undisclosed MASH target. Moreover, the Company may receive an additional payment of $15 million from Merck if Merck elects to designate a third target for collaboration. With respect to the second target in the collaboration, the Company is eligible to receive up to approximately $460.0 million in development and commercialization milestones as well as tiered royalties on net sales.
In February 2023 and May 2024, Merck provided us written notice of termination for both of the targets in the collaboration. There was no effect on the income statements as a result as all deferred revenue had been fully recognized prior to the termination notice provided.
The Company determined that the Original Agreement and First Amendment fall within the scope of ASC 808, Collaborative Arrangements (ASC 808), due to Merck and the Company being joint active participants, as well as both parties having significant risks and rewards. The Company analogized to ASC 606, Revenue from Contracts with Customers (ASC 606), for the accounting of payments including upfront payments and other milestones. Management of the Company determined that there was one performance obligation for each of the agreements given the deliverables are not distinct. The Company evaluated the performance obligation within each agreement and determined the performance obligations are satisfied over time as Merck jointly owns any collaboration intellectual property that is developed during the research term. Given the nature of the arrangements, the Company believes that the satisfaction of its performance obligations is best measured by the progress of its efforts. As such, the Company has used an input method based on costs incurred to recognize revenue associated with the upfront payments. This assessment is performed separately for each of the Original Agreement and the First Amendment, and the Company recognizes revenue over time based on the costs incurred. The effect of any updates to the estimated overall costs are recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) were evaluated based on the Company’s analysis that the probability of achieving any of the milestones is remote, and therefore determined to be constrained and excluded from the transaction price.
During the twelve months ended December 31, 2024 and 2023, the Company recognized$0.3 million and$9.3 million in revenue from collaborative arrangements related to upfront payments. During the twelve months ended December 31, 2024 and 2023, the Company recognizedno revenue from collaborative arrangements related to milestone payments. The unrecognized portion of the upfront payments received during thetwelve months ended December 31, 2024 and 2023 is recorded on the Consolidated Balance Sheets as “Deferred revenue, current”.
Changes in deferred revenue balances arose as a result of the Company recognizing the following revenue from collaborative arrangements during the periods below (in thousands):
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred revenue from collaborations as of January 1 | $84 | $8,743 |
| Consideration received in the period | 250 | 679 |
| Revenue from collaborations recognized in the period | (334) | (9,338) |
| Deferred revenue from collaborations as of December 31 | $— | $84 |
Agreement with Emory University (Emory)
In June 2018, the Company entered into a license agreement with Emory (the Emory License Agreement), pursuant to which Emory granted the Company a worldwide, sublicensable license under certain of its intellectual property rights to make, have made, develop, use, offer to sell, sell, import and export products containing certain compounds relating to Emory’s hepatitis B virus capsid assembly modulator technology, for all therapeutic and prophylactic uses. Such license is initially exclusive with respect to specified licensed patents owned by Emory and non-exclusive with respect to certain of Emory’s specified know-how. In June 2022, the license to such patents became non-exclusive with respect to all fields except for the treatment and prevention of HBV; however, the Company may select up to six compounds which will maintain exclusivity with respect to all therapeutic and prophylactic uses. With respect to all other compounds that are enabled by the licensed patents, those which are jointly invented by the Company and Emory or inventors in the Schinazi laboratory, or which are disclosed in a specified licensed patent, are licensed to the Company exclusively including as to Emory; whereas all other such compounds are licensed to the Company non-exclusively. Under the terms of the Emory License Agreement, the Company is obligated to use commercially reasonable efforts to bring licensed products to market in accordance with a mutually agreed upon development plan. Unless terminated earlier by either party in accordance with the provisions thereof, the Emory License Agreement shall continue until the expiration of the last–to-expire of the patents licensed to the Company thereunder.
In June 2020, the Company amended the license agreement with Emory. Pursuant to the amended license agreement, Emory granted the Company additional patent rights to certain compounds targeting the treatment or prevention of HBV. As consideration for the additional rights, the Company made a one-time, non-refundable payment to Emory in the amount of $0.2 million, with an additional obligation to pay up to a maximum of $35,000. On the same date, the Company entered into a collaboration agreement with Emory, with the initial research plan pertaining to the synthesis and evaluation of the compounds licensed through the additional patent rights granted in the amended license agreement. The research plan was set to terminateone year from the effective date of June 2020 but the Company exercised its option to extend it for a second year. In June 2022, the research plan terminated. In connection with the research plan, the Company will provide Emory funding up to $0.3 million per year.
The Company has agreed to pay Emory up to an aggregate of $125.0 million upon the achievement of specified development, regulatory, and commercial milestones, and all ongoing patent costs. The Company also agreed to pay Emory tiered single-digit royalties on worldwide annual net sales of licensed products, on a quarterly basis and calculated on a product-by-product basis. With respect to licensed products containing any of a specified subset of the licensed compounds, such royalties range from a mid-single digit to a high-single digit percentage rate. With respect to licensed products which do not contain such compounds, the royalties span a range of percentage rates within the mid-single digits if a Phase 1 clinical trial is initiated for the product within three years of the effective date of the Emory License Agreement, and range from a low-single digit to a mid-single digit rate if a Phase 1 clinical trial is initiated more than three years after the effective date.
During the twelve months ended December 31, 2024 and 2023, the Company hadno expenses related to milestone payments. During thetwelve months ended December 31, 2024 and 2023, the Company madeno payments associated with royalties but did recognize general expenses of $0.1 million and $0.4 million, respectively.
Agreement with Luxna Biotech Co., Ltd. (Luxna)
On December 19, 2018, the Company entered into a license agreement with Luxna, pursuant to which Luxna granted the Company an exclusive, worldwide, sublicensable license under certain of Luxna’s intellectual property rights to research, develop make, have made and commercialize for all therapeutic and prophylactic uses, (i) products containing oligonucleotides targeting the hepatitis B virus genome, (ii) products containing certain oligonucleotides targeting up to three genes which contribute to MASH, which the Company may select at any time during the first eight years of the term, to the extent not licensed to a third party, and (iii) products containing oligonucleotides targeting up to three genes which contribute to hepatocellular carcinoma, which the Company may select at any time during the first three years of the term, which expired in December 2021. As consideration for this agreement, the Company paid an upfront license fee of $0.6 million.
In April 2020, the Company amended the license agreement with Luxna. Pursuant to the amended license agreement, Luxna granted the Company an exclusive, worldwide license under the licensed patents to research, develop, make, have made and commercialize products containing oligonucleotides targeting three families of viruses: Orthomyxoviridae, Paramyxoviridae, and Coronaviridae (a family which includes SARS-CoV-2). As consideration for the amended license agreement, the Company paid Luxna a one-time non-refundable fee of $0.2 million in April 2020. The Company is obligated to make payments to Luxna, in aggregate, totaling up to but no more than $55.5 million upon the achievement of specified development, regulatory, and commercial milestones.
During the year ended December 31, 2024 and 2023, the Company recognizedno expenses related to milestone payments. The Company is also required to pay Luxna a low-single digit royalty percentage on net sale of applicable products, if any. During thetwelve months ended December 31, 2024 and 2023, the Company madeno payments associated with royalties.
Agreement with Katholieke Universiteit Leuven (KU Leuven)
On June 25, 2020, the Company entered into a Research, Licensing and Commercialization Agreement (KU Leuven Agreement) with KU Leuven, under which the Company is collaborating with KU Leuven’s Rega Institute for Medical Research, as well as its CD3, to research and develop potential protease inhibitors for the treatment, diagnosis or prevention of coronaviruses, including of SARS-CoV-2. Unless terminated earlier by either party in accordance with provisions in the agreement, the collaboration period will terminate at the earlier of completion of all collaboration activities or 2.5 years. In connection with the KU Leuven Agreement, KU Leuven and the Company granted each other exclusive cross-licenses to use certain know-how and existing patents of the other party as well as certain joint know-how and joint patents to carry out research and development collaboration activities during the collaboration period. As of December 2022, the original collaboration period has expired. An amendment to the agreement was agreed in July 2023 to include a new collaboration plan. KU Leuven granted to the Company an exclusive (including as to KU Leuven), worldwide license under certain of KU Leuven’s know-how and existing patents, and certain joint patents and joint know-how, to manufacture and commercialize the licensed products for the treatment, diagnosis or detection of viral infections in humans. KU Leuven reserved the right to use all KU Leuven knowhow, existing KU Leuven patents, joint patents and joint know-how for academic and non-commercial research and teaching purposes. As consideration for this license, the Company is obligated to make payments to KU Leuven, in aggregate, totaling up to but no more than $30.0 million upon the achievement of certain commercial sales milestones. For each licensed product developed through KU Leuven and the Company’s collaborative effort, the Company is obligated to make payments to KU Leuven, in aggregate, totaling up to $32.0 million upon the achievement of certain development and regulatory milestones. The Company is also required to pay KU Leuven a low-to-mid-single digit royalty percentage, subject to certain adjustments, on net sales of applicable products, if any. The Company is also required to pay a share of upfront transaction consideration received to KU Leuven should the program be partnered with an external party. Unless terminated earlier by either party, the agreement shall continue until the expiration of the last to expire royalty term, which is the later of the expiration or termination of the last valid patent claim covering the manufacture, use, sale or importation of the licensed product in a particular country or 10 years after the first commercial sale of a licensed product.
During the year ended December 31, 2023, we recognized and paid $2.0 million related to milestone payments due to the first dosing of the first patient in a Phase 1 clinical trial. No milestone payments were made in the year ended December 31, 2024.
- Revenue from contracts with customers
Agreement with Amoytop
In May 2023, the Company and Amoytop Biotech Co., Ltd (Amoytop) entered into an exclusive Development Agreement and Research Collaboration Agreement with a focus on nucleic acid technology for HBV treatment, with the Company granting to Amoytop an exclusive option to enter into an exclusive license to develop and commercialize such compounds. Under the terms of the agreement, the Company received an upfront payment of $7.0 million, less withholding taxes of $1.1 million from Amoytop. With respect to the agreement, the Company will be eligible for up to $109.0 million in development and commercialization milestones as well as tiered royalties on net sales. These potential payments consist of (i) potential development milestones (such as for the commencement of a Good Laboratory Practice toxicology study for a collaboration compound, approval of IND by regulatory authority, initiation of Phase 2 and 3 clinical trials, and regulatory approval of a licensed product), and (ii) sales-based milestones.
The Company determined that the Amoytop agreement falls within the scope of ASC 606. The agreement did not fall under the ASC 808 guidance due to Amoytop and the Company not being joint active participants, and both parties not having significant risks and rewards. Management of the Company determined that there were three performance obligations for the agreement given the deliverables are distinct. The Company evaluated the standalone selling price for each obligation based on available data for similar arrangements. The Company evaluated the performance obligations and determined the provision of R&D services for the collaboration compound performance obligation will be satisfied over time, the research license including data and know-how has been satisfied, and the provision of materials will be satisfied upon delivery. Given the nature of the arrangement, the Company believes that the satisfaction of its performance obligations is best measured by the progress of its efforts as it relates to the performance of the R&D services. As such, the Company has used an input method based on costs incurred to recognize revenue associated with the upfront payments, and the Company recognizes revenue over time based on the costs incurred. The effect of any updates to the estimated overall costs are recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) were evaluated based on the Company’s analysis that the probability of achieving any of the milestone payments is remote, and therefore determined to be constrained and excluded from the transaction price.
Agreement with ADCT
The Company determined that the ADC Therapeutics (ADCT) agreement falls within the scope of ASC 606. The agreement did not fall under the ASC 808 guidance due to ADCT and the Company not being joint active participants, nor both parties having significant risks and rewards. Management of the Company determined that there was one performance obligation for the agreements given the deliverables are not distinct. The Company evaluated the performance obligation and determined the performance obligations are satisfied over time. Given the nature of the arrangement, the Company believes that the satisfaction of its performance obligations is best measured by the progress of its efforts. As such, the Company has used an input method based on costs incurred to recognize revenue associated with the upfront payments, and the Company recognizes revenue over time based on the costs incurred. The effect of any updates to the estimated overall costs are recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) were evaluated based on the Company’s analysis that the probability of achieving any of the milestones is remote, and therefore determined to be constrained and excluded from the transaction price.
During the twelve months ended December 31, 2024 and 2023, the Company recognized$3.6 million and$6.2 million, respectively, in revenue from customers related to upfront payments. During the twelve months ended December 31, 2024 and 2023, the Company recognizedno revenue from customers related to milestone payments. The unrecognized portion of the upfront payments received during thetwelve months ended December 31, 2024 and 2023 is recorded on the Consolidated Balance Sheets as “Deferred revenue from customers”.
Changes in deferred revenue balances arose as a result of the Company recognizing the following revenue from customers during the periods below (in thousands):
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred revenue from customers as of January 1 | $1,224 | $700 |
| Consideration received in the period | 2,538 | 6,715 |
| Revenue from customers recognized in the period | (3,611) | (6,191) |
| Deferred revenue from customers as of December 31 | $151 | $1,224 |
- Income taxes
The components of the current provision for income taxes were as follows for the years ended December 31, 2024 and 2023:
| 2024 · 2023 | ||||
|---|---|---|---|---|
| Current: | ||||
| State | $ | - | $ | - |
| Federal · - · - | ||||
| Foreign | 331 | 795 | ||
| Total current provision for income taxes | $331 | $795 | ||
| Deferred: | ||||
| State | $ | - | $ | - |
| Federal | - | - | ||
| Foreign | - | - | ||
| Total deferred provision for income taxes | $ | - | $ | - |
The Company didnot have any deferred provision for income taxes for the years ended December 31, 2024 and 2023.
A reconciliation of the expected income tax computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows for the years ended December 31, 2024 and 2023:
| 2024 | 2023 | |
|---|---|---|
| Income tax computed at federal statutory rate | 21.00% | 21.00% |
| State taxes, net of federal benefit | 4.49% | 6.71% |
| Research tax credits | 0.79% | 6.35% |
| Change in valuation allowance | -17.04% | 86.68% |
| Stock based compensation | -1.92% | -2.30% |
| Permanent differences | 0.10% | -0.63% |
| Section 382 limitation | 0.00% | -117.98% |
| Foreign tax | -0.27% | -0.76% |
| Warrant marked to market | -7.41% | 0.00% |
| Effective income tax rate | -0.26% | -0.93% |
The components of the deferred tax assets and liabilities were as follows at December 31:
| 2024 · 2023 | ||||
|---|---|---|---|---|
| Deferred tax assets: | ||||
| Net operating loss carryforward | $17,625 | $3,491 | ||
| Operating lease liabilities | 2,418 | 3,280 | ||
| Tax credits | 2,745 | 941 | ||
| Other accruals and reserves | 1,457 | 1,622 | ||
| Stock-based compensation | 1,555 | 2,714 | ||
| Deferred revenue | - | 24 | ||
| Capitalized Sec 174 costs | 31,848 | 23,962 | ||
| Other | 626 | 577 | ||
| 58,274 | 36,611 | |||
| Valuation allowance | (56,517) | (34,235) | ||
| Net deferred tax assets | $1,757 | $2,376 | ||
| Deferred tax liabilities: | ||||
| Right of use assets | (1,520) | (2,078) | ||
| Stock-based compensation | - | - | ||
| Property and equipment | (237) | (298) | ||
| Total deferred tax liabilities | $(1,757) | $(2,376) | ||
| Total deferred income taxes | $ | - | $ | - |
Management believes that, based on a number of factors, including the Company’s historical operating performance and accumulated deficit, it is more likely than not that the deferred tax assets will not be utilized, such that a full valuation allowance has been recorded against the Company’s deferred tax assets. In assessing the reliability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized on a jurisdiction-by-jurisdiction basis. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The valuation allowance increased by$22.3 million during the year ended December 31, 2024, and decreased by$75.3 million during the year ended December 31, 2023.
As of December 31, 2024, the Company had$41.8 million of federal and$90.7 million of state net operating loss (NOL) carryforwards available to offset future taxable income. The Company’s federal NOL carryforwards can be carried forward indefinitely while state NOL carryforwards, if not utilized, will begin expiring in 2043. As of December 31, 2024, the Company had research and development credit carryforwards of$1.9 million and$1.2 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. If not utilized, the federal credit carryforwards will begin expiring in 2043. The California credit carryforwards have no expiration date. The Company had$8.4 million of Australian NOL carryforwards and$0.6 million of Australian research and development tax credit carryforwards.
Under Sections 382 and 383 of the Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage point change (by value) in its equity ownership over a rolling three-year period), the Company’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. The Company performed a Code Section 382 analysis in 2023 and determined there was an ownership change that resulted in Section 382 limitations, the impact of which is reflected in the financial statements. The Company performed a Code Section 382 analysis in 2024, which resulted in no further ownership changes.
Wemay experience additional ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. In the future, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards or other tax attributes to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us and could adversely affect our business, results of operations, and cash flows. In addition, under current tax law, federal NOL carryforwards generatedin periods after December 31, 2017, may be carried forward indefinitely but, may only be used to offset 80% of our taxable income.
ASC 740-10 prescribes a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or expected to be taken on a tax return. It is the Company’s policy to include penalties and interest expense related to income taxes as a component of other expense and interest expense, respectively, as necessary. During the years ended December 31, 2024 and 2023, the Company hadnot recognized any tax-related penalties or interest. No liability related to uncertain tax positions is recorded on the financial statements related to uncertain tax positions.
| 2024 | 2023 | |
|---|---|---|
| Balance, beginning of the period | $99 | $3,100 |
| Increase (Decrease) related to prior year positions | 17 | (3,100) |
| Increase related to current year positions | 655 | 99 |
| Balance, end of the period | $771 | $99 |
The Company does not expect that its uncertain tax positions will materially change in the next twelve months. The reversal of the uncertain tax benefits would not impact the Company's effective tax rate as the Company continues to maintain a full valuation allowance against its deferred tax assets.
The Company files income tax returns in the United States, including California and Texas, Australia, Belgium, and China. The Company is not currently under examination by income tax authorities in federal, state or other jurisdictions. All income tax returns will remain open for examination by the federal, state and foreign authorities for three or four years, from the date of utilization of any NOLs or credits.
In October 2021, the Organization for Economic Co-operation and Development (OECD)/G20 finalized the significant components of a two-pillar global tax reform plan, which has now been agreed to by the majority of OECD members. Pillar Two requires multinational enterprises with annual global revenue exceeding €750 million to pay a global minimum tax of 15%. The Company does not currently expect to meet the €750 million revenue threshold. The Company will continue to evaluate the potential impact on future periods of the Pillar Two framework and the implementation of the Pillar Two rules in the jurisdictions in which it operates.
- Commitments and contingencies
From time to time, the Company may have certain contingent liabilities, including legal matters that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. Contingent liabilities requiring accrual were appropriately accrued as of December 31, 2024 and December 31, 2023. The Company enters into contracts in the normal course of business that includes arrangements with clinical research organizations, vendors for preclinical research and vendors for manufacturing. These agreements generally allow for cancellation with notice. As of December 31, 2024, the Company had no material non-cancelable purchase commitments.
- Benefit plans
Defined contribution plans
The Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company made matching contributions of$0.7 million and$0.8 million to the plan during the years ended December 31, 2024 and 2023, respectively.
Defined benefit plans—regular pension plan
ASC Topic 715, Compensation—Retirement Benefits, requires an employer to: (a) recognize in its statement of financial position an asset for a plan’s overfunded status or a liability for a plan’s under-funded status; (b) measure a plan’s assets and its obligations that determine its funded status as of the end of the employer’s fiscal year; and (c) recognize changes in the funded status of a defined benefit post retirement plan in the year in which the changes occur. Accordingly, the Company is required to report changes in its funded status on its Consolidated Statement of Changes in Stockholders’ (Deficit) Equity and Consolidated Statement of Operations and Comprehensive Loss.
Aligos-Belgium offers its employees a regular pension plan in the form of a defined contribution plan (the Regular Pension Plan), which contains a 2.50% legally required minimum rate of return for the participants. The Regular Pension Plan does not meet all the requirements that are needed for recognition of the plans as a defined contribution plan. The Company therefore recognizes the Regular Pension Plan as a defined benefit plan.
The Company measures the fair value of the Regular Plan assets by using Level 3 inputs, unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of assets, including pricing models, discounted cash flow methodologies and similar techniques.
The net periodic benefit cost of the Pension Plan was$0.1 million and$0.2 million, and is recognized in accrued liabilities on the Consolidated Balance Sheets as of December 31, 2024 and 2023, respectively. As of December 31, 2024, the projected benefit obligation was$1.3 million, the plan assets were$1.3 million and the net pension liability was$0.1 million. As of December 31, 2023, the projected benefit obligation was$1.2 million, the plan assets were$1.2 million, and the net pension liability was$0.1 million. The Company has recorded the unfunded amount as a liability in its Consolidated Balance Sheets at December 31, 2024 and 2023, under the accrued liabilities caption. The unrealized actuarial gain and loss on pension benefits, net of tax, at December 31, 2024 and 2023 was$62.0 thousand and$40.0 thousand, respectively. These amounts were reflected in other comprehensive loss under the caption gain (loss) on pension plans. The Company expects to make contributions to the Pension Plan of approximately$0.2 million during 2024. The Company estimates future benefit payments from 2025 to 2028 to be$0.3 million, and from 2029 thereafter to be$0.9 million.
Defined benefit plans—Top Hat Plan
In Aligos-Belgium, the Company established a pension bonus complementary plan (the Top Hat Plan), where the bonus payments to each participant are added to the Top Hat Plan. The annual contributions to this plan are based on performance and determined on a discretionary basis by the Company. The Top Hat Plan contains a legal yield guarantee of 1.75%. The Top Hat Plan became effective as of January 1, 2019.
In 2019, the Company accounted for the Top Hat Plan in accordance with ASC 715, Compensation—Retirement Benefits, once it became effective. The Top Hat Plan does not meet all the requirements that are needed for recognition as a defined contribution plan. The Company therefore recognizes the Top Hat Plan as a defined benefit plan.
The net periodic benefit cost of the Top Hat Plan was$0.2 million and$0.2 million, and is recognized in accrued liabilities on the Consolidated Balance Sheets as of December 31, 2024 and 2023, respectively. As of December 31, 2024, the projected benefit obligation was$2.1 million, the plan assets were$1.9 million and the net pension liability was$0.2 million. As of December 31, 2023, the projected benefit obligation was$2.0 million, the plan assets were$1.8 million, and the net pension liability was$0.2 million. The Company has recorded the unfunded amount as a liability in its Consolidated Balance Sheets at December 31, 2024 and 2023, under the accrued liabilities caption. The unrealized actuarial gain and loss on pension benefits, net of tax, at December 31, 2024 and 2023 was$14.0 thousand and$3.0 thousand, respectively. These amounts were reflected in other comprehensive loss under the caption gain (loss) on pension plans. The Company expects to make contributions to the Pension Plan of approximately$0.2 million during 2024. The Company estimates future benefit payments from 2025 to 2028 to be$0.4 million, and from 2029 thereafter to be$1.2 million.
- Net loss per share
The following table summarizes the computation of basic and diluted net loss per share of the Company:
| Year Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Net loss | $(131,211) | $(87,679) |
| Weighted average common stock outstanding | 6,264,612 | 2,563,470 |
| Net loss per share - basic and diluted | $(20.94) | $(34.20) |
The Company’s potentially dilutive securities, which include options to purchase common stock, unvested restricted stock and warrants to purchase common stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential shares of Common Stock, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:
| Year Ended | ||
|---|---|---|
| December 31, | ||
| 2024 | 2023 | |
| Options to purchase common stock | 441,113 | 415,073 |
| Unvested restricted stock | 1,379 | 5,361 |
| Warrants to purchase common stock | 2,200,858 | 2,249,680 |
| 2,643,350 | 2,670,114 | |
- Segment information
The CODM assesses performance for the Company’ssingle reportable segment and decides how to allocate resources based on the Company’s total operating expenses as reported on the Consolidated Statements of Operations and Comprehensive Loss. The CODM’s review of total operating expenses at the consolidated level is used to monitor the Company’s spending as well as budget versus actual results. As part of the CODM’s review of the segment’s performance, the CODM reviews the Company’s operating expense information. This includes research and development costs as well as general and administrative expenses. Based upon the operating expense information, the CODM can reconcile to net loss as reported on the Consolidated Statements of Operations and Comprehensive Loss, shown in the table below. The significant expense categories are consistent with those presented on the face of the consolidated financial statements, except for the breakout of the early-stage research and development from the late-stage research and development. The CODM does not receive or use any other segmented or disaggregated financial or any significant expense information for decision making purposes.
The following table provides segment revenues, significant segment expenses and reported segment net income for the years ended December 31, 2024 and 2023:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Revenue from collaborations | $334 | $9,338 |
| Revenue from Customers | 3,611 | 6,191 |
| Less: | ||
| Early-stage research and development(1) | (3,506) | (9,213) |
| Late-stage research and development(2) | (66,763) | (63,827) |
| General & Administrative | (22,830) | (30,616) |
| Total operating expenses | (93,099) | (103,656) |
| Interest and other income, net | 4,406 | 3,412 |
| Change in fair value of common warrants | (46,132) | (2,169) |
| Loss before income tax | (130,880) | (86,884) |
| Income tax provision | (331) | (795) |
| Segment and consolidated net loss | $(131,211) | $(87,679) |
(1) Early-stage research and development includes costs incurred from Discovery programs.
(2) Late-stage research and development includes costs incurred from Phase 1 clinical trial programs.
The Company’s reportable segment primarily generates revenue through its license and collaboration agreements (see Notes 11 and 12). The Company has$2.1 million and$0.2 million of fixed assets in Aligos-US and Aligos-Belgium, respectively, as of December 31, 2024, and$2.9 million and$0.3 million of fixed assets in Aligos‑US and Aligos-Belgium, respectively as of December 31, 2023.
- Subsequent events
In preparing the interim financial statements for the year ended December 31, 2024, the Company evaluated subsequent events for recognition and measurement purposes during which time the following event has occurred that require disclosure:
PIPE offering
On February 13, 2025, the Company closed its PIPE offering (the 2025 Private Placement) with certain investors (the Purchasers) that resulted in gross proceeds of approximately $105.0 million. In the 2025 Private Placement, the Company issued (i)2,103,307 shares of the Company’s common stock, par value $0.0001 per share, consisting of 1,427,000 shares of voting Common Stock and 676,307 shares of non-voting Common Stock, (ii) pre‑funded warrants (the Pre-Funded Warrants) to purchase up to 1,922,511 shares of voting Common Stock and (iii) accompanying common warrants (the Common Warrants) to purchase up to 2,012,909 shares of voting Common Stock. The combined price per share of Common Stock and accompanying Common Warrant was $26.0825 and the combined price per Pre-Funded Warrant and Common Warrant was $26.0824.
Each Pre-Funded Warrant has a nominal exercise price of $0.0001 per share of Common Stock, is immediately exercisable and does not expire. Each Common Warrant has an exercise price of $26.02, is immediately exercisable and will expire in February 2032.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.