Nuvation Bio Inc
For the period ended Dec 31, 2023. Filed Feb 29, 2024.
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FY2023 · Filed Feb 29, 2024
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Notes to Consolidated Financial Statements
NOTE 1. DESCRIPTION OF ORGANIZATION AND BUSINESS OPERATIONS
Nuvation Bio Inc. and subsidiaries (“Nuvation Bio”), a Delaware corporation, is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio was incorporated on March 20, 2018 (inception date) and has offices in New York and San Francisco.
On February 10, 2021, (the “Closing Date”), Nuvation Bio Inc., a Delaware corporation (“Legacy Nuvation Bio”), Panacea Acquisition Corp. (“Panacea”), and Panacea Merger Subsidiary Corp, a Delaware corporation and a direct, wholly owned subsidiary of Panacea (“Merger Sub”) consummated the transactions contemplated by an Agreement and Plan of Merger among them dated October 20, 2020 (“Merger Agreement”).
Pursuant to the terms of the Merger Agreement, a business combination of Panacea and Legacy Nuvation Bio was effected through the merger of Merger Sub with and into Legacy Nuvation Bio, with Legacy Nuvation Bio surviving as a wholly owned subsidiary of Panacea (the “Merger”) and, collectively with the other transactions described in the Merger Agreement. On the Closing Date, Legacy Nuvation Bio changed its name to Nuvation Bio Operating Company Inc. and Panacea changed its name to Nuvation Bio Inc. (the “Company” or “Nuvation Bio”).
NOTE 2. SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
Principles of Consolidation
The consolidated financial statements include the balances of the Company and its subsidiaries. All intercompany transactions and balances are eliminated in consolidation.
Liquidity
As of December 31, 2023, the Company has an accumulated deficit of approximately$342.8 million and net cash used in operating activities was approximately $68.0 million for the year ended December 31, 2023. Management expects to continue to incur operating losses and negative cash flows from operations for the foreseeable future.
As of December 31, 2023, the Company had cash, cash equivalents, and marketable securities of $611.2 million. The Company believes that its existing cash, cash equivalents, and marketable securities will be sufficient to meet its cash commitments for at least the next 12 months after the date that these consolidated financial statements are issued. The Company’s research and development activities can be costly, and the timing and outcomes are uncertain. The assumptions upon which the Company has based its estimates are routinely evaluated and may be subject to change. The actual amount of the Company’s expenditures will vary depending upon a number of factors including but not limited to the progress of the Company’s research and development activities and the level of financial resources available.
Significant Risks and Uncertainties
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of research and development, clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company’s products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital.
The Company currently has no commercially approved products and there can be no assurance that the Company’s research and development will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and vendors and obtaining and protecting intellectual property.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenue and expenses during the year. Accordingly, actual results could differ from those estimates and those differences could be significant. Significant estimates and assumptions reflected in the accompanying consolidated financial statements include, but are not limited to, the fair value of in-process research and development acquired, warrant liabilities, leases, stock options granted and depreciation expense.
Cash and Cash Equivalents
Cash equivalents include short-term, highly liquid instruments, consisting of money market accounts, a money market mutual fund and short-term investments with maturities from the date of purchase of 90 days or less. The majority of cash and cash equivalents are maintained with major financial institutions in North America. Deposits with these financial institutions may exceed the amount of insurance provided on such deposits. These deposits may be redeemed upon demand which reduces counterparty performance risk.
Marketable Securities
Debt securities have been classified as available-for-sale which may be sold before maturity as they are not classified as trading securities or as held-to-maturity securities. Marketable debt securities classified as available-for-sale are carried at fair value with unrealized gains or losses reported in other comprehensive income (loss). Exchange traded funds are equity securities, which are reported as marketable securities with readily determinable fair values, are also carried at fair value with unrealized gains and losses included in other (expense) income, net. Realized gains and losses on both debt and equity securities are included in other (expense) income, net.
For securities in an unrealized loss position, management considers the extent and duration of the unrealized loss, and the financial condition and near-term prospects of the issuer. Management also assesses whether it intends to sell, or it is more likely than not that it will be required to sell, a security in an unrealized loss position before recovery of its amortized cost basis. If management determines there is any other than temporary impairment, the entire difference between amortized cost and fair value is recognized as impairment through earnings.
The Company is exposed to credit losses primarily through its available-for-sale investments. The Company assesses whether its available-for sale investments are impaired at each reporting period. Unrealized losses or impairments resulting from the amortized cost basis of any available-for-sale debt security exceeding its fair value are evaluated for identification of credit losses and non-credit related losses. Any credit losses are charged to earnings against the allowance for credit losses of the debt security, limited to the difference between the fair value and the amortized cost basis of the debt security. Any difference between the fair value of the debt security and the amortized cost basis, less the allowance for expected credit losses, are reported in other comprehensive income (loss). Expected cash inflows due to improvements in credit are recognized through a reversal of the allowance for expected credit losses subject to the total allowance previously recognized. The Company’s expected loss allowance methodology for the debt securities includes reviewing the extent of the unrealized loss, the size, term, geographical location, and industry of the issuer, the issuers’ credit ratings and any changes in those ratings, as well as reviewing current and future economic market conditions and the issuers’ current status and financial condition. As of December 31, 2023, the Company has not recognized an allowance for expected credit losses related to available-for-sale investments as the Company has not identified any unrealized losses for these investments attributable to credit factors.
Interest income includes amortization and accretion of purchase premium and discount. Premiums and discounts on debt securities are amortized on the effective-interest method. Gains and losses on sales are recorded on the settlement date and determined using the specific identification method.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents and marketable securities. The Company maintains its cash and cash equivalent balances in the form of business checking accounts and money market accounts, the balances of which, at times, may exceed federally insured limits. Exposure to cash and cash equivalents credit risk is reduced by placing such deposits with major financial institutions and monitoring their credit ratings. Marketable securities consist primarily of government and corporate bonds, municipal securities and exchange traded fund with fixed interest rates. Exposure to credit risk of marketable securities is reduced by maintaining a diverse portfolio and monitoring their credit ratings.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the related assets of generally five years for computers andseven years for furniture and equipment. The cost of leasehold improvements is amortized on the straight-line method over the lesser of the estimated asset life or remaining term of the lease. Maintenance costs are expensed as incurred, while major betterments are capitalized.
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and an impairment assessment may be performed on the recoverability or the carrying amounts. If an impairment occurs, the loss is measured by comparing the fair value of the asset to its carrying amount.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own ordinary shares, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded as a liability at their fair value on the date of issuance and each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations.
Following the Merger, there were 5,787,472 warrants to purchase common stock outstanding, consisting of 4,791,639 Public Warrants,162,500 Private Placement Warrants and 833,333 Forward Purchase Warrants (as defined below). Each whole warrant entitles the registered holder to purchase one share of our Class A common stock at a price of $11.50 per share. Pursuant to the warrant agreement, a warrant holder may exercise its warrants only for a whole number of shares of our Class A common stock.
The Company evaluated Public Warrants, Private Placement Warrants and Forward Purchase Warrants (the “Warrants”) under ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity, and concluded that they do not meet the criteria to be classified in stockholders’ equity. Specifically, the settlement value of the Warrants is dependent, in part, on the holder of the Warrants at the time of settlement. Because the holder of an instrument is not an input into the pricing of a fixed-for-fixed option on our common stock, the Warrants fail the indexation guidance in ASC 815-40, which would preclude classification in stockholders’ equity. Additionally, the exercise of the Warrants may be settled in cash upon the occurrence of a tender offer or exchange that involves more than 50% of the outstanding shares of the Company’s common stock. Becausenot all of the Company’s stockholders need to participate in such tender offer or exchange to trigger the potential cash settlement and the Company does not control the occurrence of such an event, the Company concluded that the Warrants do not meet the conditions to be classified in equity. Since the Warrants meet the definition of a derivative under ASC 815, the Company recorded these Warrants as liabilities on the balance sheet at fair value upon the closing of the Merger, with subsequent changes in their respective fair values recognized in the consolidated statement of operations and comprehensive loss at each reporting date. The fair value of Public and Forward Purchase Warrants was determined using the closing price of the warrants on the NYSE market. The fair value of the Private Warrants was estimated using a Black-Scholes option pricing formula (see Note 3).
Leases
The Company determines if an arrangement contains a lease at inception. For arrangements where the Company is the lessee, operating leases are included in operating lease right-of-use, or ROU assets; current operating lease liabilities; and non-current operating lease liabilities on its balance sheets. The Company currently does not have any finance leases.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. ROU assets also include any initial direct costs incurred and any lease payments made on or before the lease commencement date, less lease incentives received. The Company uses its incremental borrowing rate based on the information available at the commencement date in determining the lease liabilities as the Company’s leases generally do not provide an implicit rate. The incremental borrowing rate is reevaluated upon a lease modification. The operating lease ROU asset also includes any initial direct costs and prepaid lease payments made less any lease incentives. The Company considered information available at the adoption date of Topic 842 to determine the incremental borrowing rate for leases in existence as of this date. The incremental borrowing rate used was the weighted average rate between secured and unsecured lending arrangement. Lease terms may include options to extend or terminate the lease when the Company is reasonably certain that the option will be exercised. Variable payments included in the lease agreement are expensed as incurred. Lease expense is recognized on a straight-line basis over the lease term.
The Company elected to apply each of the practical expedients described in ASC Topic 842-10-65-1(f) which allow companies not to reassess: (i) whether any expired or existing agreements contain leases, (ii) the classification of any expired or existing leases, and (iii) the capitalization of initial direct costs for any existing leases. The Company also elected to apply the short-term lease measurement and recognition exemption in which ROU assets and lease liabilities are not recognized for short-term operating leases. A short-term operating lease is a lease that, at the commencement date, has a lease term of 12 months or less and does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise. The Company also elected not to separate non-lease components from lease components and instead to account for each separate lease component and the non-lease components associated with that lease component as a single lease component.
Segment Information
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s operations are focused on oncology development activities.
Research and Development Costs
Costs incurred in connection with research and development activities are expensed as incurred. These costs include fees paid to consultants, vendors and various entities that perform certain research and testing on behalf of the Company.
Stock-based Compensation
The Company recognizes compensation cost for grants of employee stock options using a fair-value measurement method, that is recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. Forfeitures are recorded as they occur instead of estimating forfeitures that are expected to occur.
The Company determines the fair value of stock-based awards that are based only on a service condition using the Black-Scholes option-pricing model which uses both historical and current market data to estimate fair value. The method incorporates various assumptions such as the risk-free interest rate, volatility, dividend yield, and expected life of the options.
The Company determines the fair value of stock-based awards that are based on both a service condition and achievement of the first to occur of a market or performance condition using a Monte Carlo simulation.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. The difference between the financial statement and tax basis of assets and liabilities is determined annually. Deferred income tax assets and liabilities are computed for those differences that have future tax consequences using the currently enacted tax laws and rates that apply to the years in which they are expected to affect taxable income. 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 through a charge to income tax expense.
The Company uses a recognition threshold and measurement attribute for the 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. The Company’s policy is to record interest and penalties related to income taxes as part of the tax provision. Returns for tax years beginning with those filed for the period ended December 31, 2018 are open to federal and state tax examination.
Accounting Pronouncements Adopted
In June 2016, the FASB issued Topic 326 on the measurement of credit losses for financial assets measured at amortized cost, which includes accounts receivable, and available-for-sale debt securities. The guidance amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities. As a smaller reporting company, this guidance is effective for fiscal years beginning after December 15, 2022. The Company adopted the standard effective January 1, 2023 using the modified retrospective approach. The adoption of the guidance did not have a material effect on the Company’s unaudited condensed consolidated financial statements and no allowance was recorded for expected credit losses. See “Marketable Securities” above for a description of the Company’s credit losses accounting policy.
Recent Accounting Pronouncements
In November 2023, the FASB issued Topic 280 "Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. This guidance is effective for our annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. We are currently evaluating the potential effect that the updated standard will have on our financial statement disclosures.
In December 2023, the FASB issued Topics 740 "Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. This guidance is effective for our annual periods beginning January 1, 2025, with early adoption permitted. We are currently evaluating the potential effect that the updated standard will have on our financial statement disclosures.
NOTE 3. FAIR VALUE MEASUREMENTS AND MARKETABLE SECURITIES
The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:
Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
Level 3 — Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.
The following table presents information about the Company’s marketable securities and the Warrant liability as of December 31, 2023 and 2022, measured at fair value on a recurring basis, and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value. The Company’s Warrant liabilities are included within the Level 1 and Level 3 fair value hierarchy. The fair value of the Public and Forward Purchase Warrants is determined using the closing price of the warrants on the NYSE market. The fair value of the Private Placement Warrants is determined using the Black-Scholes option pricing formula. The primary unobservable input utilized in determining the fair value of the Private Warrants is the expected volatility. The expected volatility was estimated considering observable Nuvation public warrant pricing, Nuvation’s own historical volatility and the volatility of guideline public companies. There have not been any transfers between the levels during the periods.
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| (In thousands) | ||||
| Financial assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $20,574 | $20,574 | $— | $— |
| U.S. government securities | 4,988 | — | 4,988 | — |
| Corporate bonds | 947 | — | 947 | — |
| 26,509 | 20,574 | 5,935 | — | |
| Marketable securities: | ||||
| Certificate of deposits | 10,176 | — | 10,176 | — |
| Commercial paper | 23,628 | — | 23,628 | — |
| U.S. government and government agency securities | 453,175 | — | 453,175 | — |
| Corporate bonds | 81,585 | — | 81,585 | — |
| 568,564 | — | 568,564 | — | |
| Total financial assets: | $595,073 | $20,574 | $574,499 | $— |
| Financial liabilities: | ||||
| Warrants | $353 | $338 | $— | $15 |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| (In thousands) | ||||
| Financial assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $35,204 | $35,204 | $— | $— |
| U.S. government and government agency securities | 32,779 | — | 32,779 | — |
| Corporate bonds | 328 | — | 328 | — |
| 68,311 | 35,204 | 33,107 | — | |
| Marketable securities: | ||||
| Certificate of deposits | 13,984 | — | 13,984 | — |
| Commercial paper | 50,173 | — | 50,173 | — |
| U.S. government and government agency securities | 305,657 | — | 305,657 | — |
| Corporate bonds | 187,130 | — | 187,130 | — |
| Municipal bonds | 2,971 | — | 2,971 | — |
| 559,915 | — | 559,915 | — | |
| Total financial assets: | $628,226 | $35,204 | $593,022 | $— |
| Financial liabilities: | ||||
| Warrants | $850 | $813 | $— | $37 |
Marketable securities consist primarily of U.S. government and government agency, certificate of deposits, commercial paper, corporate bond and municipal securities ("Debt Securities"). Based on the Company’s intentions regarding its marketable securities, all Debt Securities are classified as available-for-sale and are carried at fair value based on the price that would be received upon sale of the security.
The following table provides the amortized cost, aggregate fair value, and unrealized gains (losses) of marketable securities as of December 31, 2023 and December 31, 2022:
| AmortizedCost · Unrealized Gains · Unrealized Losses · Fair Value | ||||||
|---|---|---|---|---|---|---|
| (In thousands) | ||||||
| Cash equivalents: | ||||||
| Money market funds | $20,574 | $— | $— | $20,574 | ||
| U.S. government and government agency securities | 4,987 | 1 | — | 4,988 | ||
| Corporate bonds | 947 | — | — | 947 | ||
| 26,508 | 1 | — | 26,509 | |||
| Marketable securities: | ||||||
| Certificate of deposits | 10,171 | 7 | (2) | — | 10,176 | |
| Commercial paper | 23,609 | 22 | (3) | 23,628 | ||
| U.S. government and government agency securities | 452,813 | 1,095 | (733) | 453,175 | ||
| Corporate bonds | 81,791 | 68 | (274) | 81,585 | ||
| 568,384 | 1,192 | (1,012) | 568,564 | |||
| $594,892 | $1,193 | $(1,012) | $595,073 | |||
| AmortizedCost | Unrealized Gains | Unrealized Losses | Fair Value | |
|---|---|---|---|---|
| (In thousands) | ||||
| Cash equivalents: | ||||
| Money market funds | $35,204 | $— | $— | $35,204 |
| U.S government and government agency securities | 32,773 | 6 | — | 32,779 |
| Corporate bonds | 328 | — | — | 328 |
| 68,305 | 6 | — | 68,311 | |
| Marketable securities: | ||||
| Certificate of deposits | 13,998 | 6 | (20) | 13,984 |
| Commercial paper | 50,240 | 21 | (88) | 50,173 |
| U.S government and government agency securities | 308,510 | 30 | (2,883) | 305,657 |
| Corporate bonds | 189,695 | 23 | (2,588) | 187,130 |
| Municipal bonds | 3,004 | — | (33) | 2,971 |
| 565,447 | 80 | (5,612) | 559,915 | |
| $633,752 | $86 | $(5,612) | $628,226 | |
For the years ended December 31, 2023 and 2022, the activity related to the net gains (losses) on marketable securities included in other income (expense) on the consolidated statements of operations and comprehensive loss were as follows (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Realized gains (losses) on available-for-sale securities were as follows: | ||
| Realized gains from sales of available-for-sale securities | $70 | $9 |
| Realized losses from sales of available-for-sale securities | (209) | (1,065) |
| (139) | (1,056) | |
| Net gains (losses) on equity securities were as follows: | ||
| Net realized losses on equities sold | — | (172) |
| Net unrealized losses on equities | — | — |
| — | (172) | |
| Total losses on marketable securities | $(139) | $(1,228) |
The following tables provide marketable securities with continuous unrealized losses for less than 12 months and 12 months or greater and the related fair values as of December 31, 2023 and 2022 were as follows:
| Less than 12 Months · 12 Months or Greater · Total · Total | ||||||
|---|---|---|---|---|---|---|
| Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | |
| (In thousands) | ||||||
| Certificate of deposits | $5,693 | $(2) | $— | $— | $5,693 | $(2) |
| Commercial paper | 9,101 | (3) | — | — | 9,101 | (3) |
| U.S. government and government agency securities | 199,552 | (694) | 24,761 | (38) | 224,313 | (732) |
| Corporate bonds | 21,844 | (28) | 26,484 | (246) | 48,328 | (274) |
| $236,190 | $(727) | $51,245 | $(284) | $287,435 | $(1,011) | |
| Less than 12 Months · 12 Months or Greater · Total · Total | ||||||
|---|---|---|---|---|---|---|
| Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | Fair Value | Unrealized Losses | |
| (In thousands) | ||||||
| Certificate of deposits | $7,139 | $(20) | $— | $— | $7,139 | $(20) |
| Commercial paper | 26,938 | (88) | — | — | 26,938 | (88) |
| U.S. government and government agency securities | 150,126 | (977) | 101,095 | (1,906) | 251,221 | (2,883) |
| Corporate bonds | 69,402 | (565) | 108,748 | (2,023) | 178,150 | (2,588) |
| Municipal bonds | — | — | 2,971 | (33) | 2,971 | (33) |
| $253,605 | $(1,650) | $212,814 | $(3,962) | $466,419 | $(5,612) | |
Maturity information based on fair value of the available-for-sale securities is as follows as of December 31, 2023:
| Within one year | After one yearthrough five years | Total | |
|---|---|---|---|
| (In thousands) | |||
| Certificate of deposits | $10,176 | $— | $10,176 |
| Commercial paper | 23,628 | — | 23,628 |
| U.S. government and government agency securities | 255,508 | 197,667 | 453,175 |
| Corporate bonds | 57,448 | 24,137 | 81,585 |
| $346,760 | $221,804 | $568,564 | |
NOTE 4. PROPERTY AND EQUIPMENT
Property and equipment, net consisted of the following:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (In thousands) | ||
| Computers | $488 | $506 |
| Furniture and fixtures | 553 | 530 |
| Leasehold improvements | 342 | 316 |
| Total property and equipment | 1,383 | 1,352 |
| Less accumulated depreciation and amortization | (666) | (458) |
| Total property and equipment, net | $717 | $894 |
Depreciation and amortization expense related to property and equipment was $0.2 million for the years ended December 31, 2023 and 2022.
NOTE 5. ACCRUED EXPENSES
Accrued expenses consisted of the following:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (In thousands) | ||
| Accrued consultant fees | $4,917 | $5,362 |
| Accrued employee compensation | 4,349 | 3,987 |
| Accrued professional fees | 280 | 236 |
| Accrued other taxes | 144 | 112 |
| Accrued other | 103 | 119 |
| $9,793 | $9,816 | |
NOTE 6. LEASES
Our principal executive office is located in New York, New York, where we lease approximately 7,900 square feet of office space under a lease that terminates in 2027, with an option for the Company toextendthe lease for an additional five years which is not reasonably assured of exercise. We also occupy approximately 25,139 square feet of office space in San Francisco, California, under a lease that terminates in 2025.
Operating lease expense was $1.7 million and $1.5 million for the years ended December 31, 2023 and 2022, respectively. Expense related to variable leases wasnot significant for the years ended December 31, 2023 and 2022. Operating cash flows for the year ended December 31, 2023 and 2022 included$1.7 million and $1.2 million, respectively.
The following table presents the future minimum lease analysis of the Company's operating lease liabilities showing the aggregate lease payments as of December 31, 2023.
| (In thousands) | |
|---|---|
| 2024 | $2,172 |
| 2025 | 1,416 |
| 2026 | 629 |
| 2027 | 81 |
| Total undiscounted lease payments | 4,298 |
| Less: imputed interest | (291) |
| Total operating lease liabilities | $4,007 |
The weighted average incremental borrowing rate used to determine the operating lease liabilities was 6.92%. The Company's weighted average remaining lease term was 2.21 years as of December 31, 2023.
NOTE 7. STOCKHOLDERS’ EQUITY
Common Stock
As of December 31, 2023, the Founder owns 100% of the outstanding Class B common stock.
Common Stock Restriction Agreement
As a result of the Merger, the shares subject to the “Stock Restriction Agreement” between the Company and the Founder was adjusted based on the Exchange Ratio. The number of shares, as adjusted, subject to repurchase per the terms of the Stock Restriction Agreement is reduced each month by 1,101,240 Class A common shares and no common shares will be subject to repurchase by June 2022. As of December 31, 2023, there areno shares of Class A Common Stock subject to the repurchase option.
Voting
Holders of Class A and Class B common stock are entitled toone vote per share on all matters, except that the holders of Class A common stock do not participate in the election of the directors who are elected exclusively by the holders of Class B common stock. Holders of Class A and Class B common stock vote together as a single class on all matters, except that (i) the holders of Class B common stock have the right, voting as a separate class, to elect and remove without cause three directors plus at least 50% of any directors in excess of seven, and (ii) the approval of the holders of a majority of Class B common stock, voting as a separate class, is required for approval by the stockholders of any acquisition (whether by merger, sale of shares or sale of assets) or liquidation. There are no cumulative voting rights.
Conversion
Each share of Class B common stock will automatically convert into one share of Class A common stock upon transfer to a non-authorized holder. In addition, the Class B common stock is subject to a “sunset” provision under which all outstanding shares of Class B common stock will automatically convert into an equal number of shares of Class A common stock if ownership of shares of Class A and Class B common stock held by our President and Chief executive Officer, David Hung, M.D., falls below an aggregate of 43,188,000 shares or if Dr. Hung dies, becomes disabled or ceases to be our Chief Executive Officer, unless he is terminated from such position by us without cause.
NOTE 8. NET LOSS PER SHARE
Basic loss per share is computed by dividing net loss by the weighted-average number of shares of Class A and Class B common stock outstanding, but excluding shares of common stock subject to repurchase for the period. The number of common stock shares subject to repurchase was determined prospectively from the date of the Stock Restriction Agreement described in Note 7. Diluted loss per share reflects the potential dilution that could occur if the stock options to issue common stock were exercised. The Company had a net loss in all periods presented thus the dilutive net loss per common share is the same as the basic net loss per common share as the effect of any options or conversions is anti-dilutive.
The earnings per share amounts are the same for the different classes of common stock because the holders of each class are legally entitled to equal per share distributions whether through dividends or liquidation.
The following securities outstanding at December 31, 2023 and 2022 have been excluded from the calculation of weighted average shares outstanding:
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Warrants | 5,787,462 | 5,787,462 |
| Class A common stock options | 30,649,239 | 22,865,714 |
NOTE 9. ACCUMULATED OTHER COMPREHENSIVE (LOSS) INCOME
The following table presents a rollforward of the changes in accumulated other comprehensive (loss) income for the years ended December 31, 2023 and 2022, which is all attributable to unrealized gains (losses) on available-for-sale securities. All amounts are net of tax.
| 2023 | 2022 | |
|---|---|---|
| (In thousands) | ||
| Balance at beginning of period | $(5,526) | $(1,185) |
| Unrealized gain (loss) | 5,568 | (5,569) |
| Amount reclassified for realized loss on marketable securities | 139 | 1,228 |
| Balance at end of period | $181 | $(5,526) |
NOTE 10. STOCK-BASED COMPENSATION
The 2021 Equity Incentive Plan
In March 2019, the Company adopted the 2019 Equity Incentive Plan or (“2019 Plan”), which provided for the grant of options, stock appreciation rights, restricted stock, and other stock awards. In January 2021, our board of directors adopted the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan was approved by our stockholders in February 2021 and became effective immediately upon the Closing Date of the Merger. Shares available for future issuance under the 2019 Plan were canceled.
Awards. The 2021 Plan provides for the grant of incentive stock options (“ISOs”), within the meaning of Section 422 of the Code to employees, including employees of any parent or subsidiary, and for the grant of nonstatutory stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of awards to employees, directors and consultants, including employees and consultants of our affiliates.
Authorized Shares. The maximum number of shares of Class A common stock that may be issued under the 2021 Plan was initially set at 50,684,047 shares of Class A common stock. The number of shares of Class A common stock reserved for issuance under the 2021 Plan will automatically increase on January 1 of each year, starting on January 1, 2022 through January 1, 2031, in an amount equal to (1)4.0% of the total number of shares of Class A common stock and Class B common stock outstanding or issuable upon conversion or exercise of outstanding instruments on December 31 of the preceding year, or (2) a lesser number of shares of Class A common stock determined by our board of directors prior to the date of the increase. The maximum number of shares of Class A common stock that may be issued on the exercise of ISOs under the 2021 Plan is three times the number of shares available for issuance upon the 2021 Plan becoming effective or 152,052,141 shares.
The Employee Stock Purchase Plan
In January 2021, our board of directors adopted the 2021 Employee Stock Purchase Plan (the “ESPP”). The ESPP was approved by our stockholders in February 2021 and became effective immediately upon the Closing Date of the Merger.
Share Reserve. The maximum number of shares of Class A common stock that may be issued under the 2021 ESPP was initially set at 4,750,354 shares of Class A common stock. The number of shares of Class A common stock reserved for issuance under the 2021 ESPP will automatically increase on January 1st of each year, beginning on January 1, 2022 and continuing through and including January 1, 2031, by 1.0% of the total number of shares of Class A common stock and Class B common stock outstanding or issuable upon conversion or exercise of outstanding instruments on December 31st of the preceding calendar year or such lesser number of shares of Class A common stock as determined by our board of directors. Shares subject to purchase rights granted under the 2021 ESPP that terminate without having been exercised in full will not reduce the number of shares available for issuance under the 2021 ESPP.
The stock-based compensation expense included in the Company’s Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022 is as follows (in thousands):
| Years ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development | $8,797 | $6,326 |
| General and administrative | 10,716 | 9,966 |
| $19,513 | $16,292 | |
Options with Service Conditions
Options granted with only service conditions generally vest over four years and expire afterten years. Stock option activity with service condition only for employees and members of the Company’s Board of Directors for the year ended December 31, 2023 is as follows:
| Shares IssuablePursuant toStock Options · Weighted-AverageExercise Price · Weighted-AverageRemaining ContractualTerm (Years) · Aggregate IntrinsicValue (in thousands) | |||||
|---|---|---|---|---|---|
| Outstanding at December 31, 2022 | 18,607,807 | $4.46 | |||
| Granted | 11,088,220 | $1.87 | |||
| Forfeited | (2,646,368) | $3.47 | |||
| Exercised | (215,614) | $1.74 | $130 | ||
| Outstanding at December 31, 2023 | 26,834,045 | $3.51 | 8.12 | $— | |
| Exercisable at December 31, 2023 | 9,371,168 | $4.57 | 6.94 | $— | |
All unvested options as of December 31 ,2023 are expected to vest. The weighted average grant-date fair value of stock options outstanding on December 31, 2023 and 2022 was$2.57 and $3.00 per share, respectively. Total unrecognized compensation costs related to non-vested stock options at December 31, 2023 was$32.2 million and is expected to be recognized within future operating results over a weighted-average period of 2.09 years.
For stock options granted with only service conditions during the years ended December 31, 2023 and 2022, the inputs in the Black-Scholes option-pricing model to determine the fair value is as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Exercise price | $1.61 - $1.94 | $1.91 - $6.10 |
| Risk-free interest rate | 3.47% - 4.12% | 1.69% - 3.75% |
| Expected volatility | 74% - 75% | 80% - 82% |
| Expected term in years | 5.50 - 6.08 | 5.50 - 6.08 |
| Dividend | 0% | 0% |
The Company estimated its expected stock volatility based on the blended average of its historical volatility and of publicly traded set of peer companies. The expected term of the Company’s options has been determined utilizing the “simplified” method. 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. Dividend yield is based on the expectation that the Company will not pay any cash dividends in the foreseeable future.
Options with Service, Market, and Performance Conditions
Options granted with combined service, market, and performance conditions will vest based on achievement of various service conditions and either a market-based or performance-based goals in three tranches with multiple categories such as the Company’s market capitalization, and clinical and regulatory milestones. The market-based and performance-based goals period ends in October 2030. The explicit service periods arethree years for tranche 1, four years for tranche 2, and five years for tranche 3. Upon the vesting requirement,20% of the options will vest for each of tranche 1 and 2, and 60% of the options granted for tranche 3 will vest. The Company recognizes the fair value of the options within each tranche over the longer of their explicit service period or derived service period. The achievement of the performance condition was not deemed probable on the date of grant. As of December 31, 2023, the performance condition was not deemed probable. The expense recognized is based on the fair value of the market condition for the years ended December 31, 2023 and 2022. Stock option activity with combined service, market, and performance conditions for employees for the year ended December 31, 2023 is as follows:
| Shares IssuablePursuant toStock Options | Weighted-AverageExercise Price | Weighted-AverageRemaining ContractualTerm (Years) | Aggregate IntrinsicValue (in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2022 | 4,257,907 | $6.54 | ||
| Granted | 340,250 | $1.70 | ||
| Forfeited | (782,963) | $5.63 | ||
| Outstanding at December 31, 2023 | 3,815,194 | $6.31 | 7.29 | $— |
| Exercisable at December 31, 2023 | 395,277 | $4.93 | 4.80 | $— |
The weighted average grant-date fair value of stock options outstanding on December 31, 2023 and 2022 was$4.03 and $2.71 per share, respectively. Total unrecognized compensation costs related to non-vested stock options at December 31, 2023 was$5.8 million and is expected to be recognized within future operating results over a weighted-average period of 4.1 years.
The fair value of the stock options granted with combined service, market, and performance conditions was based on a Monte Carlo simulation with an embedded Black-Sholes pricing model. For the years ended December 31, 2023 and 2022, the fair value was computed using the following assumptions:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Exercise price | $1.61 - $1.94 | $1.91 - $6.10 |
| Risk-free interest rate | 3.40% - 3.92% | 1.77% - 2.97% |
| Expected volatility | 72% - 73% | 74% - 75% |
| Expected term in years | 6.17 - 6.30 | 5.63 - 6.98 |
| Dividend | 0% | 0% |
The determination of expected volatility, risk- free rate, and dividend yield was the same approach as used for the above stock options granted with service only conditions. The expected term period represents the time used as an input in the embedded Black-Sholes pricing model which is based on the midpoint between the vest and expiration dates for each tranche.
NOTE 11. 401(K) PLAN
The Company sponsors a 401(k) plan (the “Plan”) covering substantially all employees of the Company. The Plan allows employees to contribute tax deferred salary deductions into the Plan under the provisions of Section 401(k) of the Internal Revenue Code. Matching contributions are made by the Company up to a maximum amount of 3% of employee contributions, subject to certain limitations as defined in the Plan. The Company made matching contributions of $0.4 million and$0.6 million for the years ended December 31, 2023 and 2022, respectively.
NOTE 12. WARRANTS
Following the Merger, there were 5,787,472 warrants to purchase common stock outstanding, consisting of 4,791,639 Public Warrants,162,500 Private Placement Warrants and 833,333 Forward Purchase Warrants. Each whole warrant entitles the registered holder to purchase one share of our Class A common stock at a price of $11.50 per share. Pursuant to the warrant agreement, a warrant holder may exercise its warrants only for a whole number of shares of our Class A common stock. At December 31, 2023, there were an aggregate of 5,787,462 warrants outstanding.
The Company concluded that the Public Warrants, Private Warrants and Forward Purchase Warrants do not meet the conditions to be classified in equity. The Warrants were recorded at fair value with subsequent changes in fair value reflected in earnings (see Note 4). The change in fair value resulted in again of $0.5 million for the year ended December 31, 2023.
The fair value of Public and Forward Purchase Warrants is determined using the closing price of the warrants on the NYSE market and the related Warrant Liability is included in Level 1 fair value measurements. The Company utilizes the Black-Scholes option pricing formula to determine the fair value of the Private Warrants at each reporting period, with changes in fair value recognized in the statement of operations. The estimated fair value of the Warrant liability for the Private Warrants is determined using Level 3 inputs. Inherent in a binomial options pricing model are assumptions related to expected share-price volatility, expected life, risk-free interest rate and dividend yield. The annualized volatility of the equity was based on a calibration to the publicly traded Warrant price as of the valuation date. The risk-free interest rate was estimated using linear interpolation assuming a term consistent with the time until the Warrants expire, and yield information was based on U.S. Treasury Constant Maturities. The expected life of the Warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates remaining at zero.
The aforementioned Warrant liabilities are not subject to qualified hedge accounting.
There wereno transfers between Levels 1, 2 or 3 during the period ended December 31, 2023.
The following table provides quantitative information regarding Level 3 fair value measurements:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Stock price | $1.51 | $1.92 |
| Strike price | $11.50 | $11.50 |
| Term (in years) | 2.1 | 3.1 |
| Volatility | 82.7% | 73.0% |
| Risk-free rate | 4.1% | 4.1% |
| Dividend yield | 0.0% | 0.0% |
The Company determined the following fair values for the outstanding Warrants (in thousands):
| Public Warrants | $288 |
|---|---|
| Private Warrants | 15 |
| Forward Purchase Warrants | 50 |
| Total | $353 |
The following presents changes in liabilities classified in Level 3 of the fair value hierarchy for the year ended December 31, 2023 (in thousands):
| Beginning balance | $37 |
|---|---|
| Change in fair value of Private Warrants liability recognized in earnings | (22) |
| Ending balance | $15 |
NOTE 13. INCOME TAXES
The Company did not record a provision or benefit for income taxes for the years ended December 31, 2023 and 2022. The components of the net deferred tax asset as of December 31, 2023 and 2022 are as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (In thousands) | ||
| Deferred tax assets: | ||
| Net operating loss carryforwards | $29,290 | $22,183 |
| Research and development tax credits | 13,133 | 11,074 |
| Capitalized research and development costs | 49,156 | 46,260 |
| Stock-based compensation | 7,307 | 4,396 |
| Accrued bonus | 1,124 | 1,090 |
| Lease liability | 1,035 | 1,165 |
| Other | 367 | — |
| Total deferred tax assets | 101,412 | 86,168 |
| Deferred tax liabilities: | ||
| Right of use asset | (931) | (1,036) |
| Other | — | (9) |
| Total deferred tax liabilities | (931) | (1,045) |
| Valuation allowance | (100,481) | (85,123) |
| Net deferred tax assets | $— | $— |
A reconciliation between the Company’s effective tax rate and the federal statutory rate for the years ended December 31, 2023 and 2022 are as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Federal statutory rate | 21.00% | 21.00% |
| State income taxes, net of federal tax benefit | 4.84% | 6.33% |
| Permanent differences | (0.10)% | (0.09)% |
| Stock based compensation | (1.33)% | (0.93)% |
| Warrants | 0.17% | 2.67% |
| Tax credits | 3.05% | 5.65% |
| True-up | (3.42)% | (0.54)% |
| Change in rate | (4.41)% | (4.67)% |
| Other items | 0.00% | 0.00% |
| Valuation allowance | (19.80)% | (29.42)% |
| Effective tax rate | 0.00% | 0.00% |
As of December 31, 2023, the Company had federal net operating loss carryforwards of approximately$95.2 million and state net operating loss carryforwards of approximately$140.3 million. The federal net operating losses have an unlimited carryover period and state net operating losses begin to expire in 2038.
As of December 31, 2023, the Company had federal research and development tax credit carryforwards of approximately$9.9 million and state research and development tax credit carryforwards of approximately$2.2 million. The federal research and development tax credits begin to expire in 2039 and state research and development tax credits have an unlimited carryover period.
As of December 31, 2023, the Company had federal orphan drug tax credit carryforwards of approximately$6.7 million. The federal orphan drug tax credits begin to expire in 2042.
All of the federal and state net operating losses may be subject to change of ownership limitations provided by the Internal Revenue Code and similar state provisions. An annual loss limitation may result in the expiration or reduced utilization of the net operating losses.
As of December 31, 2023, the Company maintained a full valuation allowance on its net deferred tax assets. The valuation allowance was determined in accordance with the provisions of ASC 740, Accounting for Income Taxes, which requires an assessment of both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. Such assessment is required on a jurisdiction by jurisdiction basis. The Company’s history of cumulative losses, along with expected future U.S. losses required that a full valuation allowance be recorded against all net deferred tax assets. The Company intends to maintain a full valuation allowance on net deferred tax assets until sufficient positive evidence exists to support reversal of the valuation allowance.
As of December 31, 2023, the Company’s total amount of unrecognized tax benefits was $5.6 million, none of which would impact the Company’s effective tax rate, if recognized. The Company does not anticipate that the amount of unrecognized tax benefit will significantly increase within the next 12 months.
For the years ended December 31, 2023 and 2022, the activity related to the unrecognized tax benefits were as follows (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Unrecognized tax benefits at beginning of year | $5,068 | $1,595 |
| Gross increases - current year tax positions | 1,019 | 2,524 |
| Gross increases - prior year tax positions | — | 949 |
| Gross decreases - prior year tax positions | (458) | — |
| Unrecognized tax benefits at end of year | $5,629 | $5,068 |
The Company is subject to taxation in the United States and various state jurisdictions. All tax years remain subject to examination for U.S. federal and state purposes. All net operating losses generated to date are subject to adjustment for U.S. federal and state purposes. The Company is not currently under examination in federal or state jurisdictions.
NOTE 14. COMMITMENTS AND CONTINGE NCIES
Commitments
The Company leases its office space under non-cancellable operating lease agreements. The leases also require the Company to pay real estate taxes and other operational expenses associated with the leased location and is included in rent expense. The effect of graduating rents, net of the rent credits, is being amortized over the life of the lease so as to result in equal monthly rent expense over the lease term. Deferred rent liability reported in the accompanying consolidated balance sheets represents the cumulative excess of straight-line rental costs over the actual rental payments.
The Company has standby letters of credit with banks in the aggregate amount of $0.6 million which serve as security for the New York and San Francisco spaces operating leases. The standby letters of credit automatically renew annually.
Contingencies
From time to time, the Company may be involved in routine litigation that arises in the ordinary course of business. There are no pending significant legal proceedings to which the Company is a party, for which management believes the ultimate outcome would have a material adverse effect on the Company’s financial position.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.