Oric Pharmaceuticals Inc
For the period ended Dec 31, 2024. Filed Feb 18, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Feb 18, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Financial Statements
- Description of the Business
ORIC Pharmaceuticals, Inc. (ORIC or the Company) is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. The Company was incorporated in Delaware in August 2014 and has offices in South San Francisco and San Diego, California. The Company’s principal operations are in the United States and the Company operates inone segment.
Since inception, the Company has devoted its primary efforts to raising capital, internal research and development activities and business development efforts and has incurred significant operating losses and negative cash flows from operations. In August 2020, the Company licensed from Mirati Therapeutics, Inc. development and commercialization rights to an allosteric inhibitor program directed towards the polycomb repressive complex 2 (PRC2) and in October 2020, the Company licensed from Voronoi Inc. development and commercialization rights to a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency against exon 20 insertion mutations.
As of December 31, 2024, the Company had an accumulated deficit of $562.8 million. Through December 31, 2024, all of the Company’s financial support has been provided by proceeds from the issuance of common stock and convertible preferred stock.
As the Company continues its expansion, it may seek additional financing and/or strategic investments, however, there can be no assurance that any additional financing or strategic investments will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain additional funding, it will most likely be required to reduce its plans and/or certain discretionary spending, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. The accompanying financial statements do not include any adjustments that might be necessary if it were unable to continue as a going concern. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date of the issuance of these financial statements.
At-The-Market Sales Agreement and Offering
The Company previously entered into an “at the market” (ATM) sales agreement with Jefferies LLC as the Company’s sales agent, to sell shares of the Company’s common stock. On March 11, 2024, pursuant to the terms of the ATM sales agreement, the Company filed a Form S-3ASR and prospectus supplement, to allow the Company to sell from time to time up to $200.0 million of shares of the Company’s common stock in negotiated transactions or transactions deemed to be an ATM offering.
Private Placements
On January 20, 2024, the Company entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 12,500,000 shares of common stock at a price of $10.00 per share, resulting in gross proceeds of $125.0 million. The purchase price per share represents a premium to ORIC's 5-day trailing average stock price at the time of sale. After deducting expenses related to the private placement of $0.2 million, the net proceeds to the Company from the private placement were $124.8 million. The private placement closed on January 23, 2024. On January 26, 2024, the Company filed a Form S-3 registering the shares sold in the private placement. The Form S-3 was declared effective by the SEC on February 2, 2024.
On June 24, 2023, the Company entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 9,285,710 shares of common stock at a price of $7.00 per share and pre-funded warrants to purchase 2,857,142 shares of common stock at a purchase price of $6.9999 per pre-funded warrant, resulting in gross proceeds of $85.0 million. The purchase price per share represents a premium to the market price at the time of sale. After deducting expenses related to the private placement of $0.2 million, the net proceeds to the Company from the private placement were $84.8 million. The private placement closed on June 27, 2023. On December 15, 2023, the Company filed a Form S-3 registering the shares sold and the shares underlying the pre-funded warrants sold in the private placement. The Form S-3 was declared effective by the SEC on December 28, 2023. On July 8, 2024, all pre-funded warrants were exercised at an exercise price of $0.0001 per share of common stock.
- Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP). The accompanying financial statements include all known adjustments necessary for a fair presentation of the results as required by GAAP. These adjustments consist primarily of normal recurring accruals and estimates that impact the carrying value of assets and liabilities. Operating results for the year ended December 31, 2024, are not necessarily indicative of future results.
Use of Estimates
The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, expenses, and the disclosure of contingent assets and liabilities in the Company’s financial statements and accompanying notes. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates.
Segment Reporting
The Company’s chief operating decision maker (“CODM”) is the Company’s Chief Executive Officer. The CODM is assisted in their responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team, consisting of executives, two senior vice presidents and a vice president.
The Company views its operations and manages its business as one operating segment, focused on the discovery and development of innovative therapies designed to counter the resistance mechanisms in cancer. Segment profit or loss is measured as the Company’s net loss as reported on the Company’s Statement of Operations and Comprehensive Loss. The Company monitors its cash and cash equivalents, short-term investments and long-term investments as reported on the Company’s Balance Sheets to determine funding for its research and development.
As the Company does not currently generate revenue, the CODM assesses Company performance through the achievement of pre-clinical and clinical research goals. In addition to the Company’s Statement of Operations and Comprehensive Loss, the CODM is regularly provided with budgeted and forecasted expense information which is used to determine the Company’s liquidity needs and cash allocation.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents and investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and investments that are recorded on its balance sheets. The Company mitigates its risk by investing in high-grade instruments and limiting the concentration in any one issuer, which limits its exposure.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with maturities of 90 days or less at the time of purchase that are readily convertible into cash as cash equivalents. These investments may include money market funds, securities issued by U.S. Government agencies, corporate debt securities and commercial paper.
Cash that is restricted and not available for general operations is considered restricted cash. The Company's restricted cash is in connection to a property lease and restrictions will be removed at the respective lease expiration.
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the balance sheet to the total of the amount presented in the statement of cash flows, in thousands:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash and cash equivalents | $59,406 | $23,384 |
| Restricted cash included in other assets | 491 | 491 |
| Total cash, cash equivalents and restricted cash | $59,897 | $23,875 |
Investments
All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Those investments with contractual maturities 12 months or greater at the balance sheet date are considered long-term investments. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold. Unrealized gains and losses are reported as a component of accumulated other comprehensive income (loss). The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in statements of operations, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive income (loss).
Property and Equipment
Property and equipment, which consist of lab equipment, leasehold improvements, computer hardware and software, and furniture and fixtures, are stated at historical cost less accumulated depreciation. Depreciation is recognized on a straight-line basis over the estimated useful lives of the related assets, which are generally three toseven years. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimate useful life of the asset.
Impairment of Property and Equipment
The Company accounts for the impairment of long-lived assets by reviewing these assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group to be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying value. If the carrying value of the long-lived asset or asset group is not recoverable on an undiscounted-cash-flow basis, an impairment is recognized to the extent that the carrying value exceeds its fair value. The Company didnot recognize impairment losses for the years ended December 31, 2024 and 2023.
Leases
The Company determines if an arrangement is or contains a lease at inception. For leases with a term greater than one year, lease right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the net present value of lease payments, the Company uses its incremental borrowing rate which represents an estimated rate of interest that the Company would have to pay to borrow equivalent funds on a collateralized basis at the lease commencement date. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations.
Research and Development Expenses and Accrued Research and Development Expenses
The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants, contract research organizations (CRO), and contract manufacturing organizations (CMO) in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts.
Research and development costs are expensed in the period in which they are incurred. External costs consist primarily of payments to outside consultants, third-party CROs, CMOs, clinical trial sites and central laboratories in connection with the Company’s discovery and preclinical activities, process development, clinical manufacturing and clinical development activities. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its service providers or its estimate of the level of service that has been performed at each reporting date. The Company tracks external costs by program, clinical or preclinical. Internal costs consist primarily of employee-related costs, laboratory supplies, facilities, depreciation and costs related to compliance with regulatory requirements. The Company does not track internal costs by program because these costs are deployed across multiple programs and, as such, are not separately classified.
The Company makes estimates of accrued expenses as of each balance sheet date based on facts and circumstances known at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The significant estimates in its accrued research and development expenses include the costs incurred for services performed by vendors in connection with research and development activities for which the Company has not yet been invoiced.
Income Taxes
The Company accounts for income taxes under 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 included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The Company recognizes deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
As of December 31, 2024 and 2023, the Company maintained valuation allowances against its deferred tax assets as the Company concluded it had not met the “more likely than not” to be realized threshold. Changes in the valuation allowance when they are recognized in the provision for income taxes would result in a change in the effective tax rate.
Stock-Based Compensation
Stock-based compensation expense represents the grant date fair value of employee, officer, director and non-employee stock option and restricted stock unit grants, estimated in accordance with the applicable accounting guidance and recognized over the vesting period, which approximates the requisite service period of the awards. The Company recognizes forfeitures as they occur.
The fair value of stock options is estimated using a Black-Scholes Merton valuation model on the date of grant. This method requires certain assumptions be used as inputs, such as a risk-free interest rate, expected volatility of the Company’s common stock and expected term of the option before exercise. The risk-free interest rate is based on U.S. Treasury instruments with maturities similar to the expected term. The expected volatility is computed using historical volatility for a period equal to the expected term. Given the limited period of time the Company's stock has been traded, expected volatility is based on the Company's historical volatility and the historical volatility of a group of similar companies that are publicly traded. The expected term represents the length of time the stock options are expected to be outstanding. Because the Company does not have sufficient exercise behavior, it determines the expected term assumption using the simplified method, which is an average of the contractual term of the option and its vesting period. Options granted have a maximum contractual term often years.
The fair value of restricted stock units is equal to the closing price of the Company's stock on the date of grant. Restricted stock units generally vest over a three-year period.
License Fees
Acquisitions of technology licenses are charged to acquired in-process research and development expense or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use.
Deferred Offering Costs
The Company capitalizes costs that are directly associated with equity financings until such financings are consummated at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss.
Other Comprehensive Gain (Loss)
Other comprehensive gain (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency gains and losses. The unrealized gains (losses) on available for sale investments represent the only component of other comprehensive loss that is excluded from the reported net loss.
Net Loss Per Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding, including pre-funded warrants issued, during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares, including pre-funded warrants issued, and potentially dilutive securities outstanding for the period. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods.
The following table sets forth the computation of the basic and diluted net loss per share (in thousands, except share and per share amounts).
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator | ||
| Net loss | $(127,847) | $(100,697) |
| Denominator | ||
| Weighted average shares outstanding used in computing net loss per share, basic and diluted | 69,727,940 | 51,450,848 |
| Net loss per share, basic and diluted | $(1.83) | $(1.96) |
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Options to purchase common stock | 11,249,452 | 8,715,529 |
| Non-vested restricted stock units | 462,507 | 330,631 |
| Total | 11,711,959 | 9,046,160 |
Recently Issued Accounting Pronouncements
There are no recently issued accounting pronouncements that would materially impact the Company's financial statements and related disclosures.
- License Agreements and Clinical Development Collaborations
Johnson & Johnson collaborations
On August 29, 2024, the Company entered into a clinical supply agreement with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), to evaluate ORIC-114 in combination SC amivantamab, Johnson & Johnson’s fully-human EGFR-MET bispecific antibody. The Company will conduct and sponsor the Phase 1b clinical trial, and Johnson & Johnson will provide SC amivantamab for the trial. The Company maintains full economic ownership and control of ORIC-114.
On July 10, 2024, the Company entered into a clinical trial collaboration and supply agreement with Johnson & Johnson, to evaluate ORIC-944 in combination with Erleada® (apalutamide), Johnson & Johnson’s AR inhibitor. The Company will continue to conduct and sponsor the ongoing Phase 1b trial, and Johnson & Johnson will provide apalutamide for the trial. The Company maintains full economic ownership and control of ORIC-944.
Bayer collaboration
On May 14, 2024, the Company entered into a clinical trial collaboration and supply agreement with Bayer Consumer Care AG (Bayer), as amended effective October 23, 2024, to evaluate ORIC-944 in combination with Nubeqa® (darolutamide), Bayer’s androgen receptor (AR) inhibitor. The Company will continue to conduct and sponsor the ongoing Phase 1b trial, and Bayer will provide darolutamide for the trial. The Company maintains full economic ownership and control of ORIC-944.
Pfizer collaboration
On December 21, 2022, the Company entered into a clinical development collaboration (the Pfizer Collaboration) for a potential Phase 2 study of ORIC-533 in multiple myeloma with Pfizer Inc. (Pfizer). Through the Pfizer Collaboration, the Company may potentially advance ORIC-533 into a Phase 2 combination study with elranatamab, Pfizer’s investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma. The Company will maintain full economic ownership and control of ORIC-533.
Voronoi License Agreement
On October 19, 2020, the Company entered into a license and collaboration agreement (Voronoi License Agreement) with Voronoi Inc. (Voronoi). The Voronoi License Agreement gives the Company access to Voronoi’s preclinical stage EGFR and HER2 exon 20 insertion mutation program, including a lead product candidate now designated as ORIC-114. Under the Voronoi License Agreement, Voronoi granted the Company an exclusive, sublicensable license under Voronoi’s rights to certain patent applications directed to certain small molecule compounds that bind to EGFR and HER2 with one or more exon 20 insertion mutations and certain related know-how, in each case, to develop and commercialize certain licensed compounds and licensed products incorporating any such compound in the ORIC Territory, defined as worldwide other than in the People’s Republic of China, Hong Kong, Macau and Taiwan. Pursuant to an amendment to the Voronoi License Agreement that the Company entered into with Voronoi on March 20, 2024, the Company also obtained the right to conduct and control certain clinical trials for the licensed products at specified clinical sites within Voronoi’s territory to support the development and commercialization of licensed products in the ORIC Territory. Under the Voronoi License Agreement, Voronoi had the right to perform certain mutually agreed upon development activities. Except for Voronoi's right to participate in such development activities, the Company is wholly responsible for development and commercialization of licensed products in the ORIC Territory. In addition, the Company is obligated to use commercially reasonable efforts to develop and commercialize at leastone licensed product in certain major markets in the ORIC Territory.
The Company’s financial obligations under the Voronoi License Agreement included an upfront payment of $5.0 million in cash and the issuance to Voronoi of 283,259 shares of the Company’s common stock, valued at approximately $6.8 million, issued pursuant to a stock issuance agreement entered into between the parties on October 19, 2020. The number of shares issued pursuant to the stock issuance agreement was based on a price of $28.24 per share, representing a premium of 25% to the 30-day trailing volume weighted average trading price of the Company’s common stock. The shares were issued in a private placement in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended, for transactions by an issuer not involving any public offering.
Under the Voronoi License Agreement, Voronoi was responsible for certain research and development costs up to a predetermined threshold. Upon achievement of the predetermined threshold in the second quarter of 2022, Voronoi chose to opt out of participation in and funding of future development activities. The Company is also obligated to make milestone payments to Voronoi upon the achievement of certain events. Upon the achievement of certain development and regulatory milestones with respect to the first licensed product, the Company is obligated to pay Voronoi up to a maximum of $111.0 million. Upon the achievement of certain commercial milestones with respect to the first licensed product, the Company is obligated to pay Voronoi up to a maximum of $225.0 million. If the Company pursues a second licensed product, the Company could pay Voronoi up to an additional $272.0 million in success-based milestones. In addition, the Company is obligated to pay royalties on net sales of licensed products in the ORIC Territory. In the third quarter of 2022, the Company made a development milestone payment to Voronoi in the amount of $5.0 million, which was recorded in acquired in-process research and development expense.
Unless earlier terminated, the Voronoi License Agreement will continue in effect until the expiration of all royalty payment obligations. Following the expiration of the Voronoi License Agreement, the Company will retain its licenses under the intellectual property Voronoi licensed to it on a royalty-free basis. The Company and Voronoi may each terminate the Voronoi License Agreement if the other party materially breaches the terms of such agreement, subject to specified notice and cure provisions, or enters into bankruptcy or insolvency proceedings. Voronoi may also terminate the agreement if the Company discontinues development of licensed products for a specified period of time. The Company also has the right to terminate the Voronoi License Agreement without cause by providing prior notice to Voronoi.
If Voronoi terminates the Voronoi License Agreement for cause, or if the Company terminates the Voronoi License Agreement without cause, then the Company is obligated to grant a nonexclusive license to Voronoi under certain of the Company’s patents and know-how and to assign to Voronoi certain of its regulatory filings for licensed compounds and licensed products.
Mirati License Agreement
On August 3, 2020, the Company entered into a license agreement (Mirati License Agreement) with Mirati Therapeutics, Inc (Mirati). Under the Mirati License Agreement, Mirati granted the Company a worldwide, exclusive, sublicensable, royalty-free license under Mirati’s rights to certain patents and patent applications directed to certain small molecule compounds that bind to and inhibit PRC2 and certain related know-how, in each case, to develop and commercialize certain licensed compounds and licensed products incorporating any such compounds. Under the Mirati License Agreement, the Company is wholly responsible for development and commercialization of licensed products. In addition, the Company is obligated to use commercially reasonable efforts to develop and commercialize at leastone licensed product in certain major markets.
The Company’s financial obligation under the Mirati License Agreement was an upfront payment of 588,235 shares of ORIC common stock, valued at approximately $13.0 million based upon the closing price of the Company’s common stock on the acquisition date. The number of shares issued was based on a price of $34.00 per share, representing a premium of 10% to the 60-day trailing volume-weighted average trading price of the Company’s common stock. The shares were issued in a private placement in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended, for transactions by an issuer not involving any public offering. During theeighteen-month period following the date of the agreement, Mirati was subject to certain transfer restrictions, and the parties agreed to negotiate and enter into a registration rights agreement, with respect to the shares. The Company is not obligated to pay Mirati milestones or royalties.
Unless earlier terminated, the Mirati License Agreement will continue in effect on a country-by-country and licensed product-by-licensed product basis until the later of (a) the expiration of the last valid claim of a licensed patent covering such licensed product in such country or (b)ten years after the first commercial sale of such licensed product in such country. Following the expiration of the Mirati License Agreement, the Company will retain its licenses under the intellectual property Mirati licensed to it on a royalty-free basis. ORIC and Mirati may each terminate the Mirati License Agreement if the other party materially breaches the terms of such agreement, subject to specified notice and cure provisions, or enters into bankruptcy or insolvency proceedings. Mirati may terminate the agreement if the Company challenges any of the patent rights licensed to the Company by Mirati or it discontinues development of licensed products for a specified period of time. The Company also has the right to terminate the Mirati License Agreement without cause by providing prior notice to Mirati.
On October 8, 2023, Bristol Myers Squibb (BMS) and Mirati announced that they entered into a definitive merger agreement under which BMS through a subsidiary will acquire all of the outstanding shares of Mirati common stock. The Mirati License Agreement continued in effect upon consummation of the transaction, which closed on January 23, 2024.
- Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lab equipment | $7,386 | $6,596 |
| Leasehold improvements | 2,043 | 1,967 |
| Computer hardware and software | 274 | 299 |
| Furniture and fixtures | 697 | 494 |
| Total property and equipment, gross | 10,400 | 9,356 |
| Less accumulated depreciation | (7,476) | (6,494) |
| Total property and equipment, net | $2,924 | $2,862 |
Depreciation expense was $1.1 million and $1.0 million for the years ended December 31, 2024 and 2023, respectively.
- Accrued Liabilities
Accrued liabilities consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Accrued clinical and manufacturing costs | $11,808 | $9,436 |
| Accrued compensation | 7,648 | 6,529 |
| Operating lease liabilities - short-term | 3,183 | 2,752 |
| Other accruals | 659 | 797 |
| Total accrued liabilities | $23,298 | $19,514 |
- Investments
The Company's available-for-sale investments consisted of the following (in thousands):
| December 31, 2024 | AmortizedCost | UnrealizedGains | UnrealizedLosses | EstimatedFair Value |
|---|---|---|---|---|
| Short-term | ||||
| U.S. treasury securities | $196,175 | $379 | $— | $196,554 |
| Short-term investments | $196,175 | $379 | $— | $196,554 |
| Short-term | ||||
| U.S. treasury securities | $181,947 | $180 | $(64) | $182,063 |
| U.S. agency bonds | 2,500 | — | (4) | 2,496 |
| Certificates of deposit | 245 | — | (1) | 244 |
| Short-term investments | $184,692 | $180 | $(69) | $184,803 |
| Long-term | ||||
| U.S. treasury securities | $26,705 | $147 | $— | $26,852 |
| Long-term investments | $26,705 | $147 | $— | $26,852 |
The Company has determined that there were no material declines in fair value of its investments due to credit-related factors as of December 31, 2024 and December 31, 2023. Credit loss is limited due to the nature of the investments.
- Fair Value Measurements
The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair-value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices in active markets;
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.
The carrying amounts of the Company’s interest receivable, included in prepaid expenses and other current assets, accounts payable and accrued liabilities are generally considered to be representative of their fair value because of their short-term nature. The Company’s investments, which may include money market funds and available-for-sale investments consisting of U.S. treasury securities, certificates of deposit and high-quality, marketable debt instruments of corporations and government sponsored enterprises, are measured at fair value in accordance with the fair value hierarchy.
Following are the major categories of assets measured at fair value on a recurring basis (in thousands):
| Fair Value Measurements | |||||
|---|---|---|---|---|---|
| Fair Value | Level 1 | Level 2 | Level 3 | Total | |
| Money market funds (1) | $59,406 | $59,406 | $— | $— | $59,406 |
| U.S. treasury securities | 196,554 | 196,554 | — | — | 196,554 |
| Total | $255,960 | $255,960 | $— | $— | 255,960 |
| Money market funds (1) | $23,384 | $23,384 | $— | $— | $23,384 |
| U.S. treasury securities | 208,915 | 208,915 | — | — | 208,915 |
| U.S. agency bonds | 2,496 | — | 2,496 | — | 2,496 |
| Certificates of deposit | 244 | 244 | — | — | 244 |
| Total | $235,039 | $232,543 | $2,496 | $— | 235,039 |
(1) Included in cash and cash equivalents in accompanying balance sheets.
No transfers between levels occurred during either of the reporting periods presented.
- Leases
Operating Leases
The Company has an operating lease for office and laboratory space in South San Francisco, California that ends in May 2028 with an option to renew for an additional one-year term. The Company also has an operating lease for office space in San Diego, California through December 2026 with an option to renew for one period of three years.
Following contains information related to the Company's leases (in thousands, except for weighted-average information):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Lease costs and cash paid: | ||
| Operating lease costs | $2,829 | $2,715 |
| Cash paid for operating leases | $2,919 | $2,757 |
| December 31, | ||
| 2024 | 2023 | |
| Lease assets: | ||
| Right-of-use assets included in other assets | $8,380 | $9,144 |
| Lease liabilities: | ||
| Lease liabilities included in accrued liabilities | $3,183 | $2,752 |
| Lease liabilities included in other long-term liabilities | 6,174 | 7,461 |
| Total lease liabilities | $9,357 | $10,213 |
| Supplemental weighted- average information: | ||
| Weighted-average discount rate | 8.3% | 8.2% |
| Weighted-average remaining lease term (years) | 3.2 | 4.2 |
Future lease payments of operating lease liabilities as of December 31, 2024, were as follows (in thousands):
| Year ending December 31, | Operating Leases |
|---|---|
| 2025 | $3,303 |
| 2026 | 3,455 |
| 2027 | 2,771 |
| 2028 | 1,049 |
| 2029 | — |
| Thereafter | — |
| Total minimum lease payments | 10,578 |
| Less: interest | 1,221 |
| Present value of lease liabilities | $9,357 |
- Stockholders' Equity and Stock-Based Compensation
As of December 31, 2024, there were 2,429,915 shares available for future issuance under the 2020 Equity Incentive Plan and 221,291 shares available for future issuance under the 2022 Inducement Equity Incentive Plan. The 2020 Equity Incentive Plan provides for the grants of stock options and other equity-based awards to employees, non-employee directors and consultants of the Company. The number of shares of the Company’s common stock available for issuance under the 2020 Equity Incentive Plan will automatically increase on the first day of each fiscal year in an amount equal to the lessor of (1)2,656,500 shares, (2)5% of the outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (3) such other amount as determined by the Company’s Board of Directors. The 2022 Inducement Equity Incentive Plan provides for the grants of equity-based awards to individuals not previously employees or non-employee directors of the Company.
The table below summarizes the total stock-based compensation expense included in the Company’s statements of operations and comprehensive loss for the periods presented (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $8,624 | $6,353 |
| General and administrative | 11,589 | 8,873 |
| Total stock-based compensation expense | $20,213 | $15,226 |
Stock Options
On June 21, 2022, the Company filed with the Securities and Exchange Commission a Tender Offer Statement on Schedule TO defining the terms and conditions of a one-time voluntary stock option exchange of certain eligible options for its employees (the Option Exchange). On July 20, 2022, the completion date of the Option Exchange, stock options covering an aggregate of 4,406,732 shares of common stock were tendered by eligible employees, and the Company granted new options at an exercise price of $4.36, the Company’s closing stock price on July 20, 2022, covering an aggregate of 4,406,732 shares of common stock under the 2020 Equity Incentive Plan in exchange for the tendered options. As a result of the Option Exchange, the Company will recognize incremental stock-based compensation expense of $3.7 million over the requisite service period of the new stock options, which is three or four years. The Company will recognize the sum of the incremental stock-based compensation expense and the remaining unrecognized compensation expense for the original awards on the modification date, over the requisite service period of the new stock options.
The following table summarizes the stock option activity for the year ended December 31, 2024:
| Options | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualTerm(in years) | AggregateIntrinsicValue(in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2023 | 8,715,529 | $4.70 | ||
| Granted | 2,926,690 | $9.33 | ||
| Exercised | (152,211) | $4.14 | ||
| Forfeited and cancelled | (240,556) | $6.58 | ||
| Outstanding at December 31, 2024 | 11,249,452 | $5.87 | 7.5 | $31,115 |
| Exercisable at December 31, 2024 | 5,901,296 | $4.57 | 6.6 | $23,428 |
The total intrinsic value of options exercised was $1.1 million and less than $0.1 million for the years ended December 31, 2024 and 2023, respectively.
The fair value of stock option awards to employees, executives, directors, and other service providers was estimated at the date of grant using the Black-Scholes Merton option pricing model with the following assumptions.
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Risk-free interest rate | 3.56% - 4.64% | 3.45% - 4.73% |
| Expected volatility | 84.40% - 86.31% | 85.32% - 87.68% |
| Expected term (in years) | 5.50 - 6.08 | 5.50 - 6.08 |
| Expected dividend yield | 0% | 0% |
The weighted-average grant-date fair value of options granted was$6.93 and$4.55 for the years ended December 31, 2024 and 2023, respectively.
The Company recognized stock-based compensation expense related to the vesting of stock optionsof $16.7 million and $12.7 million for the years ended December 31, 2024 and 2023, respectively. Total unrecognized compensation expense related to outstanding unvested stock-option awards as of December 31, 2024, was $31.6 million, which is expected to be recognized over a weighted-average remaining service period of 2.4 years.
Restricted Stock Units
The following table summarizes the restricted stock unit activity for the year ended December 31, 2024:
| Number of Shares | Weighted-AverageGrant-Date Fair Value | |
|---|---|---|
| Outstanding at December 31, 2023 | 330,631 | $6.55 |
| Granted | 467,567 | $9.40 |
| Vested | (306,850) | $7.90 |
| Forfeited | (28,841) | $7.76 |
| Outstanding at December 31, 2024 | 462,507 | $8.46 |
The Company recognized stock-based compensation expense related to the vesting of restricted stock units of $2.6 million and $1.3 million for the years ended December 31, 2024 and 2023, respectively. Total unrecognized compensation expense related to restricted stock units as of December 31, 2024, was $3.6 million, which is expected to be recognized over a weighted-average remaining service period of 1.8 years.
Employee Stock Purchase Plan
As of December 31, 2024, there were 832,261 shares available for future issuance under the 2020 Employee Stock Purchase Plan (ESPP). The number of shares of common stock available for issuance under the ESPP will automatically increase on the first day of each fiscal year in an amount equal to the lessor of (1)500,000 shares, (2)1% of the outstanding shares of the Company’s common stock on the last day of the immediately preceding fiscal year, or (3) such other amount as determined by the Company’s
Boardof Directors. The Company recognized stock-based compensation expense related to the ESPP of $0.9 million and $1.2 million for the years ended December 31, 2024 and 2023, respectively.
Pre-funded Warrants
In June 2023, the Company completed a private placement, in which it sold 9,285,710 shares of common stock together with pre-funded warrants to purchase 2,857,142 shares of common stock with an exercise price of $0.0001 per share. The Company performed an assessment upon issuance of the pre-funded warrants to determine proper classification in the financial statements based on the specific terms of the pre-funded warrants. The Company determined the pre-funded warrants met all the criteria for equity classification and recorded them in additional paid-in capital.
On July 8, 2024, the Company issued 2,857,104 shares of common stock to warrant holders upon their exercise of outstanding pre-funded warrants, pursuant to a net exercise mechanism under the pre-funded warrants. Each pre-funded warrant had an exercise price of $0.0001 per share. The issuances of the shares were exempt from registration under the Securities Act pursuant to Section 3(a)(9) thereof as an exchange with an existing security holder whereno commission or other remuneration is paid or given for soliciting such exchange. The resale of the shares of common stock issued upon the exercise of pre-funded warrants were previously registered with the Company’s registration statement on Form S-3 filed on December 15, 2023, which was declared effective by the SEC on December 28, 2023.
- Income Tax
Significant components of the Company’s provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate were as follows (in thousands):
| For the Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Statutory rate | $(26,849) | $(21,146) |
| State tax | (8,691) | (6,935) |
| Other permanent items | 132 | 60 |
| Research and development credit | (4,989) | (3,405) |
| Change in valuation allowance | 39,631 | 31,954 |
| Stock-based compensation | 766 | (528) |
| Provisions for income taxes | $— | $— |
Significant components of the Company’s deferred taxes were as follows (in thousands):
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred tax assets: | ||
| Net operating loss carryforwards | $90,687 | $75,803 |
| Research and development credits | 19,058 | 14,069 |
| Stock-based compensation | 14,424 | 10,538 |
| Accruals and other | 2,003 | 1,635 |
| Intangible assets | 6,152 | 6,713 |
| Capitalized research expense | 40,206 | 24,028 |
| Lease liability | 2,619 | 2,858 |
| Gross deferred tax assets | 175,149 | 135,644 |
| Less valuation allowance | (172,562) | (132,965) |
| Total deferred tax assets | 2,587 | 2,679 |
| Deferred tax liabilities: | ||
| Property and equipment | (136) | (120) |
| Right-of-use assets | (2,345) | (2,559) |
| Other | (106) | — |
| Total deferred tax liabilities | (2,587) | (2,679) |
| Deferred income taxes, net | $— | $— |
A valuation allowance of $172.6 million at December 31, 2024, has been recognized to offset the net deferred tax assets as realization of such assets is uncertain. The valuation allowance increased by $39.6 million during the year ended December 31, 2024.
As of December 31, 2024, the Company had available net operating loss (NOL) carryforwards of $276.7 million. Of the $276.7 million of NOL carryforwards, $41.6 million begin to expire in 2034 and $235.1 million do not expire. The Company also has available California NOL carryforwards of approximately $464.8 million as of December 31, 2024, which begin to expire in 2034. In addition, the Company has federal and California research and development (R&D) credit carryforwards totaling $16.5 million and $7.7 million, respectively. The federal credits begin to expire in 2034 unless previously utilized, while the state credits do not expire.
Pursuant to Sections 382 and 383 of the Internal Revenue Code (IRC), annual use of the Company’s NOL and credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within athree-year period. Since the Company’s formation, the Company has raised capital through the issuance of capital stock, which on its own or combined with the purchasing stockholders’ subsequent disposition of those shares, may have resulted in such an ownership change, or could result in an ownership change.
Upon the occurrence of an ownership change under Section 382 as outlined above, utilization of the Company’s NOL and research and development credit carryforwards are subject to an annual limitation, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, which could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the NOL or R&D credit carryforwards before utilization. The Company is currently in the process of conducting a Section 382 study to determine if such an ownership change has occurred.
The Company recognizes liabilities for uncertain tax positions based in a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes that it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcome of examinations by tax authorities in determining the adequacy of its provision for income taxes.
The following table summarized activity related to the Company's gross unrecognized tax benefits (in thousands):
| For the Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Beginning balance | $2,811 | $2,172 |
| Increases related to current year tax positions | 926 | 639 |
| Ending balance | $3,737 | $2,811 |
As of December 31, 2024, the Company had gross unrecognized tax benefits of $3.7 million, none of which would affect the effective tax rate if recognized. The Company does not anticipate any significant changes in its unrecognized tax benefits over the next 12 months. The Company’s policy is to recognize the interest expense and/or penalties related to income tax matters as a component of income tax expense. The Company hadno accrual for interest or penalties on its balance sheets at December 31, 2024 and hasnot recognized interest and/or penalties in its statement of operations for the year ended December 31, 2024.
The Company is subject to taxation in the United States and California. The Company is not currently under examination by any taxing authorities. Due to the carryover of tax attributes, the statute of limitations is currently open for tax years since inception.
- Employee Benefit Plan
The Company has a defined-contribution 401(k) plan for employees. Employees are eligible to participate in the plan beginning on the first day of the month following date of hire. Under the terms of the plan, employees may make voluntary contributions as a percentage of compensation. The Company matches employee contributions as permitted by the plan and may make an additional discretionary match as determined by the Company's board of directors. The Company's cost related to the 401(k) plan was $0.8 million and $0.6 million for the years ended December 31, 2024 and 2023, respectively.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.