Aligos Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 6, 2025.
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Mar 31, 2025 · Filed May 6, 2025
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Notes to Unaudited Condensed Consolidated Financial Statements
Organization and basis of presentation
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 (Aligos-Belgium), a limited liability company organized under the laws of 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 developing novel therapeutics to address unmet medical needs in viral and liver diseases, including for chronic hepatitis B virus (HBV) infection, metabolic dysfunction associated steatohepatitis (MASH), and coronaviruses.
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 nonclinical 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.
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair statement of the Company’s consolidated financial information. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the full year or any other future period. The balance sheet as of December 31, 2024 is derived from the audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete consolidated financial statements.
The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC.
Certain amounts previously reported in Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the period ended March 31, 2024 have been reclassified to conform to the current period presentation, with respect to the separate presentation of the change in fair value of 2023 Common Warrants in the amount of $14.4 million, previously included in Interest and other income (expense), net. The reclassification had no impact on our net loss.
Unaudited interim financial information
The accompanying Condensed Consolidated Balance Sheet as of March 31, 2025, the Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three months ended March 31, 2025 and 2024, the Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2025 and 2024, and the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024 are unaudited. The unaudited consolidated interim financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s consolidated financial position as of March 31, 2025 and the consolidated results of its operations and cash flows for the three months ended March 31, 2025 and 2024. The consolidated financial data and other information disclosed in these notes related to the three months ended March 31, 2025 and 2024 are unaudited. The consolidated results for the three months ended March 31, 2025 are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period.
Liquidity
The Company has incurred losses and negative cash flows from operations in each fiscal year since its inception. As of March 31, 2025 and December 31, 2024, the Company had an accumulated deficit of$574.9 million and$618.0 million, respectively. Management expects to continue to incur additional substantial losses from operations in future fiscal years in the foreseeable future as a result of its research and development activities.
As of March 31, 2025, the Company has cash, cash equivalents and investments of approximately$137.9 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/or other marketing or distribution arrangements. In addition, the Company may seek additional capital to take advantage of favorable market conditions or strategic opportunities even if the Company believes it has sufficient funds for its current or future operating plans. Based on the Company’s research and development plans, the Company expects its existing cash, cash equivalents and investments, will enable it to fund its operations for at least 12 months following the date the condensed 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.
The Company’s ability to raise additional funds depends on financial, economic and other factors, many of which are beyond its control. For example, if there is a disruption of global financial markets, the Company could be unable to access additional capital, which could negatively affect its ability to consummate certain corporate development transactions or other important, beneficial or opportunistic investments. 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.
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 maintains a dual banking system to limit its credit and liquidity risk.
Summary of significant accounting policies
Use of Estimates
The preparation of condensed consolidated 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 it believes 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 actual results could differ from these estimates.
Reverse Stock Split
On August 19, 2024, the Company effected a 1-for-25 reverse stock split of its authorized, issued and outstanding voting and non-voting common stock. All equity related information including per share amounts for all periods presented in these condensed consolidated financial statements and the notes thereto have been adjusted retroactively, where applicable, to reflect this reverse stock split.
Significant accounting policies and estimates
No material changes were made to the Company’s significant accounting policies disclosed in Note 2. Summary of significant accounting policies, in its Annual Report on Form 10-K, filed with the SEC on March 10, 2025, for the year ended December 31, 2024.
Recently issued accounting standards
From time to time, new accounting pronouncements are issued by FASB that the Company adopts as of the specified effective date. The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and has the option to not “opt out” of the extended transition related to complying with new or revised accounting standards. This means that when a standard is issued or revised and it has different application dates for public and nonpublic companies, the Company has the option to adopt the new or revised standard at the time nonpublic companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company, i.e. after December 31, 2025.
The Company has considered all recent accounting pronouncements issued, but not yet effective, and does not expect any to have a material effect on the Company’s condensed consolidated financial statements other than those discussed in its Annual Report on Form 10-K, filed with the SEC on March 10, 2025, for the year ended December 31, 2024.
Balance sheet components
Property and equipment
The components of property and equipment as of March 31, 2025 and December 31, 2024 were as follows (in thousands):
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Leasehold improvements | $6,101 | $6,101 |
| Lab equipment | 5,996 | 5,975 |
| Computer equipment | 1,077 | 1,051 |
| Furniture and office equipment | 732 | 732 |
| Vehicles and equipment | 280 | 281 |
| Asset under construction | 4 | 4 |
| Total, at cost | 14,190 | 14,144 |
| Accumulated depreciation | (11,976) | (11,782) |
| Total, net | $2,214 | $2,362 |
Depreciation expense was$0.2 million for the three months ended March 31, 2025 and$0.3 million for the three months ended March 31, 2024. Finance leases are also included in property and equipment as vehicles and lab equipment on the Condensed Consolidated Balance Sheets.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
| March 31, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Accrued R&D expenses | $3,853 | $5,029 |
| Accrued compensation | 3,449 | 6,387 |
| Accrued payables | 1,151 | 1,471 |
| Other | 2,548 | 2,670 |
| Total | $11,001 | $15,557 |
Investments
As of March 31, 2025 and December 31, 2024, amortized cost, gross unrealized gains and losses, and estimated fair values of total fixed-maturity securities were as follows (in thousands):
| Gross · Gross | |||||
|---|---|---|---|---|---|
| Amortized · Unrealized · Unrealized · Estimated | |||||
| Cost · Gain · Loss · Fair Value | |||||
| Available-for-sale securities: | |||||
| U.S. Treasury bonds | $64,102 | $ | - | $(4) | $64,098 |
| Gross · Gross | |||||
|---|---|---|---|---|---|
| Amortized · Unrealized · Unrealized · Estimated | |||||
| Cost · Gain · Loss · Fair Value | |||||
| Available-for-sale securities: | |||||
| U.S. Treasury bonds | $19,933 | $9 | $ | - | $19,942 |
Five of our short-term investments are in an unrealized loss position. 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 March 31, 2025, all investments had a remaining maturity of less thanone year.
The Company recorded interest income of$0.8 million for the three months ended March 31, 2025, and$0.6 million for the three months ended March 31, 2024. The Company recorded accrued interest receivable of$0.1 million for the three months ended March 31, 2025. There wasno accrued interest receivable as of December 31, 2024.
Fair value measurement
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.
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 (in thousands):
| Level 1 · Level 2 · Level 3 | |||||
|---|---|---|---|---|---|
| Assets: | |||||
| Available for sale securities | - | 64,098 | - | ||
| Liabilities: | |||||
| 2023 common warrants liability | - | - | (10,873) | ||
| $ | - | $64,098 | $(10,873) | ||
| Level 1 · Level 2 · Level 3 | |||||
| Assets: | |||||
| Available for sale securities | $ | - | $19,942 | $ | - |
| Liabilities: | |||||
| 2023 common warrants liability | - | - | (72,367) | ||
| $ | - | $19,942 | $(72,367) | ||
Common Warrants and Pre-Funded Warrants
2025 PIPE
In February 2025, the Company closed its private investment in public equity (PIPE) offering (the 2025 Private Placement) and entered into a securities purchase agreement with certain investors (the 2025 Securities Purchase Agreement) that resulted in gross proceedsof approximately $105.0 million. In the 2025 Private Placement, the Company issued (i)2,103,307 shares of the Company’s common stock (the 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 2025 Pre-Funded Warrants) to purchase up to 1,922,511 shares of Common Stock and (iii) accompanying common warrants (the 2025 Common Warrants) to purchase up to 2,012,909 shares of Common Stock. The purchase price per share was $26.0825, or $26.0824 per 2025 Pre-Funded Warrant, which represents the purchase price per share less the $0.0001 per share exercise price of each Pre-Funded Warrant. Each 2025 Pre-Funded Warrant is immediately exercisable and does not expire. Each 2025 Common Warrant has an exercise price of $26.02, is immediately exercisable and will expire in February 2032. The Company received net proceeds of approximately$101.7 million, after deducting the placement agent fees and expenses and offering costs.
The Company accounts for the 2025 Common Warrants and 2025 Pre-Funded Warrants in Stockholders Equity (Deficit) on the Condensed Consolidated Balance Sheet and determined the outstanding 2025 Common Warrants and 2025 Pre-Funded Warrants are freestanding derivative instruments. The Company classified the 2025 Common Warrants and 2025 Pre-Funded Warrants as equity because they met the equity scope exception under ASC 815, Derivatives and Hedging, based on the terms in the 2025 Securities Purchase Agreement.
2023 PIPE
In October 2023, the Company completed a PIPE offering and entered into a securities purchase agreement (the 2023 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, pre-funded warrants to purchase an aggregate of 3,242,018 shares of Common Stock (the 2023 Pre-Funded Warrants), and warrants to purchase an aggregate of 2,249,680 shares of Common Stock (the 2023 Common Warrants). Each 2023 Pre-Funded Warrant has an exercise price of $0.0001 per share of common stock, was immediately exercisable and is exercisable until exercised in full. Each 2023 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 following table summarizes information about shares issuable under the 2023 and 2025 Pre-Funded Warrants outstanding at December 31, 2024 and March 31, 2025:
| Pre-funded warrant shares outstanding | March 31, 2025 | December 31, 2024 |
|---|---|---|
| Outstanding at the beginning of the year | 2,441,405 | 3,242,018 |
| Issued | 1,922,511 | - |
| Exercised | (146,484) | (800,613) |
| Outstanding at the end of the period | 4,217,432 | 2,441,405 |
| Exercisable at the end of the period | 4,217,432 | 2,441,405 |
The following table sets forth a summary of the activities of the Company’s 2023 Common Warrant liability, which represents a recurring measurement that is classified with Level 3 of the fair value hierarchy wherein the fair value is estimated using significant unobservable inputs (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Beginning liability | $72,367 | $27,596 |
| Common warrants issued | - | - |
| Common warrants exercised | - | (1,361) |
| Change in fair value | (61,494) | 46,132 |
| Ending liability | $10,873 | $72,367 |
The fair value of the 2023 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 the reporting date were as follows:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Expected term (in years) | 5.58 | 5.83 |
| Risk-free interest rate | 4.00% | 4.43% |
| Dividend yield | - | - |
| Volatility | 87.21% | 84.62% |
The following table summarizes information about shares issuable under the 2023 and 2025 Common Warrants outstanding at March 31, 2025:
| Common warrant shares outstanding | March 31, 2025 | December 31, 2024 |
|---|---|---|
| Outstanding at the beginning of the year | 2,200,858 | 2,249,680 |
| Issued | 2,012,909 | - |
| Exercised | - | (48,822) |
| Outstanding at the end of the period | 4,213,767 | 2,200,858 |
| Exercisable at the end of the period | 4,213,767 | 2,200,858 |
Equity Incentive Awards and Stock-based Compensation
Stock options
Stock option activity during thethree months ended March 31, 2025 is as follows:
| Sharessubjectto options · Weighted-averageexerciseprice · Weighted-averageremainingcontractualterm (years) · AggregateIntrinsicValue (in thousands) | |||||
|---|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 627,685 | $35.93 | 8.50 | $10,611 | |
| Granted | 410,937 | 16.81 | — | — | |
| Exercised | — | — | — | — | |
| Forfeited or Expired | (28,255) | (111.02) | — | — | |
| Outstanding as of March 31, 2025 | 1,010,367 | 26.05 | 9.04 | $88 | |
| Options vested and expected to vest as of March 31, 2025 | 1,010,367 | 26.05 | 9.04 | $88 | |
| Options vested and exercisable as of March 31, 2025 | 251,095 | 52.78 | 7.54 | $ | - |
Restricted stock units
Restricted stock unit activity during thethree months ended March 31, 2025 is as follows:
| Numberof Awards | Weighted-AverageGrant DateFair Value | AggregateFair Value(in thousands) | |
|---|---|---|---|
| Issued and unvested as of December 31, 2024 | 4,729 | $15.44 | $73 |
| Granted | 13,125 | 16.87 | 221 |
| Vested and released | (590) | (16.47) | (10) |
| Issued and unvested as of March 31, 2025 | 17,264 | 16.49 | $284 |
Stock-based compensation expense was allocated as follows for thethree months ended March 31, 2025 and 2024 (in thousands):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Research and development | $543 | $1,439 |
| General and administrative | 416 | 1,209 |
| Total | $959 | $2,648 |
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.
In May 2024, the Company and Amoytop entered into a nine-month extension to the Development Agreement and Research Collaboration Agreement, covering work performed through January 2025. Under the terms of the agreement, the Company received an upfront payment of $1.5 million which was recognized from the second quarter of 2024 through the first quarter of 2025.
The Company determined that the Amoytop agreement falls within the scope of Accounting Standards Codification (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.
During the three months ended March 31, 2025 and 2024, the Company recognized$0.3 million and$0.7 million, respectively, in revenue from customers related to upfront payments. During the three months ended March 31, 2025 and 2024, the Company recognizedno revenue from customers related to milestone payments. The unrecognized portion of the upfront payments received during thethree months ended March 31, 2024 is recorded on the Condensed 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 March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Deferred revenue from customers as of January 1 | $151 | $1,224 |
| Consideration received in the period | 160 | 191 |
| Revenue from customers recognized in the period | (311) | (694) |
| Deferred revenue from customers as of March 31 | - | $721 |
Agreement with ADCT
The Company determined that the ADC Therapeutics (ADCT) agreement falls within the scope of ASC 606, Revenue from Contracts with Customers (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 possibility of achieving any of the milestone payments is remote, and therefore determined to be constrained and excluded from the transaction price. Similarly, the Company accounts for the future royalties under the sales-based royalty exception in ASC 606-10-55-65 through 55-65B therefore they are not considered in the transaction price and expected to be recognized when future sales occur since that is expected to occur after the performance obligation has been fully satisfied.
In-licensing agreements
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.
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. During thethree months ended March 31, 2025 and 2024, the Company hadno expenses related to milestone payments. 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 range from a low-single digit to a mid-single digit rate.
During the three months ended March 31, 2025 and 2024, the Company madeno payments associated with royalties and recognizedno expense or accruals.
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 thethree months ended March 31, 2025 and 2024, 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 thethree months ended March 31, 2025 and 2024, 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 Centre for Drug Design and Discovery, 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 terminated 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 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 revenue share 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 three months ended March 31, 2025, the Company madeno payments of royalties or milestones.
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 March 31, 2025 and December 31, 2024. 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 March 31, 2025, the Company had no material non-cancellable purchase commitments.
Income taxes
The Company recorded income tax provision of$43.0 thousand for the three months ended March 31, 2025, primarily related to the Company's international operations.
The Company has a history of losses in prior fiscal years and projects losses for the full year 2025. The Company continues to maintain a full valuation allowance on its net deferred tax assets.
Net income (loss) per share
The following table summarizes the computation of basic and diluted net income (loss) per share of the Company (in thousands, except share and per share data):
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Net income (loss), as reported | $43,088 | $(34,863) |
| Less: Change in fair value of the 2023 common warrants | (61,494) | - |
| Diluted net loss | $(18,406) | $(34,863) |
| Weighted average shares outstanding, basic | 8,408,481 | 6,246,113 |
| Add: Weighted average shares issuable upon exercise of 2023 common warrants | 301,212 | - |
| Weighted average shares outstanding, diluted | 8,709,693 | 6,246,113 |
| Net income (loss) per share - basic | $5.12 | $(5.58) |
| Net loss per share - diluted | $(2.11) | $(5.58) |
The Company’s potentially dilutive securities includes options to purchase common stock, unvested restricted stock and warrants to purchase common stock. For the three months ended March 31, 2025, the 2023 common warrants were dilutive and included in the total weighted average shares outstanding, diluted. For the three months ended March 31, 2024, all potentially dilutive securities 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, for the three months ended March 31, 2024, the weighted-average number of shares 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:
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Options to purchase common stock | 1,010,367 | 404,902 |
| Unvested restricted stock | 17,264 | 6,183 |
| Warrants to purchase common stock | 2,012,909 | 2,249,680 |
| 3,040,540 | 2,660,765 | |
- Segment information
The chief operating decision maker (CODM), who is defined as the Company's Chairman, President and Chief Executive Officer, 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 Income (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 income (loss) as reported on the Consolidated Statements of Operations and Comprehensive Income (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 thethree months ended March 31, 2025 and 2024 (in thousands):
| Three months ended March 31, | |||
|---|---|---|---|
| 2025 · 2024 | |||
| Revenue from Collaborations | $ | - | $292 |
| Revenue from Customers | 311 | 694 | |
| Less: | |||
| Early-stage research and development(1) | (842) | (940) | |
| Late-stage research and development(2) | (13,660) | (15,426) | |
| General & Administrative | (5,052) | (6,666) | |
| Total operating expenses | (19,554) | (23,032) | |
| Interest and other income, net | 880 | 1,579 | |
| Change in fair value of 2023 common warrants | 61,494 | (14,372) | |
| Income (loss) before income tax | 43,131 | (34,839) | |
| Income tax provision | (43) | (24) | |
| Segment and consolidated net income (loss) | $43,088 | $(34,863) | |
(1) Early-stage research and development includes costs incurred from Discovery programs.
(2) Late-stage research and development includes costs incurred from Phase 1 and Phase 2 clinical trial programs.
The Company’s reportable segment primarily generates revenue through its license and collaboration agreements (see Notes 8 and 9).
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.