Metagenomi Therapeutics, Inc.
For the period ended Dec 31, 2024. Filed Mar 17, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 17, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
Description of Business, Organization and Liquidity
Organization and Business
Metagenomi, Inc. (“Metagenomi” or the “Company”) is a precision genetic medicines company committed to developing curative therapeutics for patients using our proprietary, comprehensive metagenomics-derived genome editing toolbox.
Formation and Group Reorganizations
Metagenomi.co was incorporated in September 2016 in the State of Delaware and is headquartered in Emeryville, California. In September 2018, Metagenomi.co formed a subsidiary, Metagenomi Technologies, LLC (“Metagenomi LLC”) as its sole member. In November 2018, the two companies completed a reorganization where Metagenomi LLC became the parent of Metagenomi.co. The reorganization was a transaction of entities under common control and did not change the group. In December 2018, Metagenomi LLC formed another wholly-owned subsidiary, Metagenomi IP Technologies, LLC. Metagenomi IP Technologies, LLC did not have any operations except for the initial transfer of IP from Metagenomi.co and an ongoing license of its technology to Metagenomi.co. Key activities of Metagenomi LLC were raising capital to support operations of Metagenomi.co. In April 2020, Metagenomi.co changed its name to Metagenomi, Inc. In December 2021, the group completed another tax-free reorganization, whereby Metagenomi IP Technologies, LLC merged with and into Metagenomi, Inc.
Reorganization and Reverse Stock Split
On January 24, 2024, the Company completed a series of transactions pursuant to which Metagenomi LLC merged with and into Metagenomi, Inc., with Metagenomi, Inc. continuing as the surviving corporation (the “Reorganization”). In connection with the Reorganization, (i) all of the outstanding common unitholders received shares of common stock of Metagenomi, Inc., (ii) all of the outstanding preferred unitholders received shares of redeemable convertible preferred stock of Metagenomi, Inc. with the same rights and privileges and (iii) certain holders of profits interest units received shares of common stock and unvested restricted common stock in Metagenomi, Inc. as determined by the applicable provisions of the Amended and Restated Limited Liability Company Agreement dated December 20, 2022, as amended on July 31, 2023 (the “LLC Agreement”) in effect immediately prior to the Reorganization. In connection with the Reorganization, by operation of law, Metagenomi, Inc. acquired all assets of Metagenomi LLC, and assumed all of its liabilities and obligations. The Reorganization was a non-taxable transaction to Metagenomi, Inc. for United States (“U.S.”) income tax purposes.
On January 26, 2024, following the Reorganization, Metagenomi, Inc. effected a reverse stock split of the shares of common stock at a ratio of 1-for-1.74692 (the “Reverse Stock Split”). The number of authorized shares and par value per share were not adjusted as a result of the Reverse Stock Split. The Reorganization and the Reverse Stock Split was accounted for as a reorganization of entities under common control. All redeemable convertible preferred stock, common stock, additional paid-in-capital and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this Reorganization and Reverse Stock Split.
In connection with the Reorganization and also effecting the reverse stock split:
holders of Metagenomi LLC’s outstanding Series A-1 redeemable convertible preferred units (“Series A-1 preferred units”) received one share of Series A-1 redeemable convertible preferred stock (“Series A-1 preferred stock”) of Metagenomi, Inc. for each Series A-1 preferred unit, with an aggregate of 7,501,002 shares of Series A-1 preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series A-1 preferred stock shall become convertible into an aggregate of 4,293,867 shares of common stock;
holders of Metagenomi LLC’s outstanding Series A-2 redeemable convertible preferred units (“Series A-2 preferred units”) received one share of Series A-2 redeemable convertible preferred stock (“Series A-2 preferred stock”) of Metagenomi, Inc. for each Series A-2 preferred unit, with an aggregate of 774,473 shares of Series A-2 preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series A-2 preferred stock shall become convertible into an aggregate of 443,338 shares of common stock;
holders of Metagenomi LLC’s outstanding Series A-3 redeemable convertible preferred units (“Series A-3 preferred units”) received one share of Series A-3 redeemable convertible preferred stock (“Series A-3 preferred stock”) of Metagenomi, Inc. for each Series A-3 preferred unit, with an aggregate of 1,513,860 shares of Series A-3 preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series A-3 preferred stock shall become convertible into an aggregate of 866,589 shares of common stock;
holdersof Metagenomi LLC’s outstanding Series A-4 redeemable convertible preferred units (“Series A-4 preferred units”)
receivedone share of Series A-4 redeemable convertible preferred stock (“Series A-4 preferred stock”) of Metagenomi, Inc. for each Series A-4 preferred unit, with an aggregate of 8,280,360 shares of Series A-4 preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series A-4 preferred stock shall become convertible into an aggregate of 4,740,000 shares of common stock;
holders of Metagenomi LLC’s outstanding Series A-5 redeemable convertible preferred units (“Series A-5 preferred units”) received one share of Series A-5 redeemable convertible preferred stock (“Series A-5 preferred stock”) of Metagenomi, Inc. for each Series A-5 preferred unit, with an aggregate of 1,580,937 shares of Series A-5 preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series A-5 preferred stock shall become convertible into an aggregate of 904,990 shares of common stock;
holders of Metagenomi LLC’s outstanding Series B redeemable convertible preferred units (“Series B preferred units”) received one share of Series B redeemable convertible preferred stock (“Series B preferred stock”) of Metagenomi, Inc. for each Series B preferred unit, with an aggregate of 15,054,263 shares of Series B preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series B preferred stock shall become convertible into an aggregate of 8,617,649 shares of common stock;
holders of Metagenomi LLC’s outstanding Series B-1 redeemable convertible preferred units (“Series B-1 preferred units”) received one share of Series B-1 redeemable convertible preferred stock (“Series B-1 preferred stock”) of Metagenomi, Inc. for each Series B-1 preferred unit, with an aggregate of 7,108,480 shares of Series B-1 preferred stock outstanding, and after giving effect to the reverse stock split, such shares of Series B-1 preferred stock shall become convertible into an aggregate of 4,069,161 shares of common stock;
holders of Metagenomi LLC’s outstanding common units received one share of common stock of Metagenomi, Inc. for each common unit, with an aggregate of 3,404,585 shares of common stock outstanding, after giving effect to the reverse stock split; and
holders of Metagenomi LLC’s outstanding profits interests received 0 -0.997816 shares of common stock in accordance with the Metagenomi LLC operating agreement for each profits interest, with an aggregate of 3,884,740 shares of common stock outstanding (which includes 1,036,833 shares of unvested restricted common stock), after giving effect to the reverse stock split. Vesting terms of outstanding profits interests did not change.
On February 8, 2024, Metagenomi, Inc.’s Form S-1 Registration Statement for its initial public offering (the “IPO”) was declared effective and the common stock of Metagenomi, Inc. began trading on the Nasdaq Global Select Market under the symbol “MGX.” On February 13, 2024, the closing date of IPO, the Company issued 6,250,000 shares of common stock at a price to the public of $15.00 per share. In connection with the closing of the IPO, the Company received gross proceeds of approximately $93.8 million and net proceeds of approximately $80.7 million, after deducting underwriting discounts and commissions and other offering costs totaling approximately $13.0 million.
Immediately prior to the IPO closing, each share of Metagenomi, Inc.’s redeemable convertible preferred stock then outstanding converted into shares of common stock at a conversion ratio of 1.74692, based on the formula set forth in Metagenomi, Inc.’s amended and restated certificate of incorporation in effect immediately prior to the closing of the IPO and giving effect to the reverse stock split. In connection with the closing of the IPO, Metagenomi, Inc. increased the authorized number of shares of common stock to 500,000,000 shares, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 par value per share.
Liquidity and Going Concern
The Company has incurred significant losses from operations since its inception. As of December 31, 2024, the Company had an accumulated deficit of$223.0 million. The Company has historically financed its operations primarily through issuance of redeemable convertible preferred stock, convertible promissory notes, its collaboration agreements, and sales of its common stock. In February 2024, the Company completed its IPO for aggregate net proceeds of approximately $80.7 million, after deducting underwriting discounts and commissions and other offering costs totaling approximately $13.0 million. The Company expects to continue to incur substantial losses, and its ability to achieve and sustain profitability will depend on the successful development, approval, and commercialization of any product candidates it may develop, and on the achievement of sufficient revenue to support its cost structure. The Company may never achieve profitability and, unless and until it does, it will need to continue to raise additional capital. There can be no assurance that the Company will be successful in acquiring additional capital at levels sufficient to fund its operations or on terms acceptable to the Company or at all. Management believes that existing cash, cash equivalents and available-for-sale marketable securities as of December 31, 2024 of$248.3 million will be sufficient to fund its current operating plan for at least the next 12 months from the date of issuance of these consolidated financial statements.
Summary of Significant Accounting Policies
Basis of Presentation
These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchanges Commission (“SEC”) regarding financial reporting. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The accompanying consolidated financial statements include the accounts of Metagenomi, Inc. and the accounts of Metagenomi LLC, retroactively adjusted for the Reorganization and Reverse Stock Split (see Note 1). All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates estimates and assumptions, including but not limited to those related to revenue recognition under its collaboration agreements, the fair value of its common stock, stock-based compensation expense, accruals for research and development expenses, the fair value of long-term investments, the valuation of deferred tax assets and uncertain income tax positions. Management bases its estimates on historical experience and on various other assumptions that are 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 that are not readily apparent from other sources. Actual results may differ materially from those estimates.
Cash, Cash Equivalents and Restricted Cash
Cash equivalents are defined as short-term, highly liquid investments with original maturities of three months or less at the date of purchase. As of December 31, 2024 and 2023, the Company’s cash and cash equivalents consisted of deposit accounts and investments in money market funds.
Restricted cash of$5.2 million as of December 31, 2024 and 2023 represents security deposits in the form of a letter of credit issued in connection with the Company’s leases (see Note 8).
Marketable Securities
Investments with original maturities of greater than three months are classified as available-for-sale marketable securities on the consolidated balance sheets and consist primarily of U.S. Treasury, corporate debt obligations, commercial paper, government agency obligations, asset-backed securities and foreign debt securities. As the Company’s entire investment portfolio is considered available for use in current operations, the Company classifies all investments as available-for-sale and as current assets, even though the stated maturity may be more than one year from the current consolidated balance sheet date. Available-for-sale securities are carried at fair value, with unrealized gains and losses reported in accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity (deficit) in the consolidated balance sheets. The Company presents accrued interest receivable related to the available-for-sale securities in prepaid expenses and other current assets, separate from available-for-sale marketable securities. The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity, which are both recorded to interest income in the consolidated statements of operations and comprehensive loss.
Realized gains and losses, allowances for credit losses and impairments on available-for-sale securities, if any, are recorded to other income (expense) in the consolidated statements of operations and comprehensive loss. Realized gains and losses on the sale of securities are determined by specific identification of each security’s cost basis. The Company regularly reviews its investment portfolio to determine if any security is impaired, which would require it to record an allowance for credit losses or an impairment charge in the period any such determination is made. In making this judgment, the Company evaluates, among other things, the extent to which the fair value of a security is less than its amortized cost, its intent to sell or whether it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, the financial condition of the issuer and any changes thereto, and, as necessary, the portion of a decline in fair value that is credit-related.
The Company’s policy is to exclude the applicable accrued interest from both the fair value and the amortized cost basis of its available-for-sale securities for purposes of identifying and measuring an impairment. The Company’s accounting policy is to not measure an allowance for credit losses for accrued interest receivable and to write-off any uncollectible accrued interest receivable as areversal of interest income in a timely manner, which it considers to be in the period in which the Company determines the accrued interest will not be collected.
Long-Term Investments
The Company determines at the inception of each arrangement whether an investment or other interest is considered a variable interest entity (“VIE”). If the investment or other interest is determined to be a VIE, the Company evaluates whether it is considered the primary beneficiary. The primary beneficiary of a VIE is the party that meets both of the following criteria: (i) has the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) has the obligation to absorb losses or the right to receive benefits from the VIE. For investments in VIEs in which the Company is considered the primary beneficiary, the assets, liabilities and results of operations of the VIE are included in the Company’s consolidated financial statements. As of December 31, 2024 and 2023, there were no VIEs for which the Company was the primary beneficiary.
If the Company concludes that it exercises significant influence over an investees’ operations, it may account for its investment either using the equity method of accounting or fair value method. The election to account for an investment at fair value is irrevocable unless an event occurs creating a new election date. If the Company does not have a significant influence, it accounts for its investment at fair value and may elect to account for an equity security without a readily determinable fair value using the measurement alternative method. The measurement alternative method allows the Company to measure the equity investment at its cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. Changes in fair value and impairment losses are recognized as other income (expense) in the consolidated statements of operations and comprehensive loss.
Concentration of Credit Risk and Other Risks and Uncertainties
Cash and cash equivalents, available-for-sale marketable securities and preferred and common stock related to our investment in Affini-T Therapeutics, Inc. (“Affini-T”) (see Note 5) are financial instruments that potentially subject the Company to concentrations of credit risk. Cash and cash equivalents consist of cash deposited with financial institutions in the United States. Account balances may exceed federally insured limits. The Company invests in money market funds, U.S. Treasuries, corporate debt obligations, commercial paper, government agency obligations and asset-backed securities, which can be subject to certain credit risks. The Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer and monitoring the ongoing creditworthiness of the financial institutions and issuers. The Company has not experienced any losses on its financial instruments.
The Company is subject to certain risks and uncertainties, including, but not limited to, changes in any of the following areas that the Company believes could have a material adverse effect on the future financial position or results of operations: the Company’s ability to advance the development of its next generation gene-editing platform, timing and ability to advance any product candidates it may develop into and through pre-clinical and clinical development; costs and timelines associated with the manufacturing of clinical supplies of any product candidates the Company may develop; regulatory approval, market acceptance of, and reimbursement for any product candidates the Company may develop; performance of third-party vendors; competition from pharmaceutical or other gene-editing companies with greater financial resources or expertise; protection of intellectual property; litigation or claims against the Company based on intellectual property or other factors; and its ability to attract and retain employees necessary to support its growth.
The Company’s business and operations may also be affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as inflationary pressures, interest rate and currency rate fluctuations, economic slowdown or recession, banking instability, monetary policy changes, geopolitical tensions or the outbreak of hostilities or war, including from the ongoing Russia-Ukraine conflict, the current conflict in Israel and Gaza (including any escalation or expansion) and increasing tensions between China and Taiwan.
Concentration of Collaboration Revenue and Accounts Receivable
The percentages of collaboration revenue and accounts receivable from each of the Company’s customers that individually accounted for 10% or more of its total collaboration revenue and accounts receivable were as follows:
| Years Ended December 31, | ||
|---|---|---|
| Collaboration Revenue | 2024 | 2023 |
| Customer A | 58% | 49% |
| Customer B | 36% | 40% |
| Customer C | * | 11% |
| 94% | 100% | |
| As of December 31, | ||
|---|---|---|
| Accounts Receivable | 2024 | 2023 |
| Customer A | 84% | * |
| Customer B | * | 20% |
| Customer C | 16% | 80% |
| 100% | 100% | |
*the customer did not account for 10% or more of collaboration revenue or accounts receivable
As of December 31, 2024 and 2023, the Company hadno contract assets. The Company reviews its accounts receivable and contract assets for impairment and credit loss allowance. No impairment or credit loss allowance was recorded as of December 31,2024 and 2023.
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
Assets and liabilities recorded at fair value on a recurring basis in the consolidated balance sheets, are categorized based upon the level of judgment associated with inputs used to measure their fair values. The accounting guidance for fair value provides a framework for measuring fair value and requires certain disclosures about how fair value is determined. The accounting guidance establishes a three-level valuation hierarchy that prioritizes the inputs to valuation techniques used to measure fair value based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows:
Level 1— Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;
Level 2— Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and
Level 3— Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. An assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. The Company recognizes transfers into and out of levels within the fair value hierarchy in the period in which the actual event or change in circumstances that caused the transfer occurs.
The carrying amounts of cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and other liabilities, approximate fair value due to their short-term maturities. Financial instruments, such as money market funds, marketable securities and certain equity and long-term investments are measured at fair value at each reporting date. Usually, marketable securities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. U.S. Government bonds, corporate debt obligations, commercial paper, government agency obligations and asset-backed securities are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2. Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. The Company’s investments in preferred stock, common stock and warrants of Affini-T (see Note 5) are Level 3 financial assets.
Deferred Finance Issuance Costs
Deferred finance issuance costs, consisting of legal, accounting and audit fees relating to in-process equity financings and initial public offering, are capitalized. The deferred finance issuance costs are offset against offering proceeds upon the completion of the financing or the offering. In the event the financing or the offering is terminated or delayed, the deferred finance issuance costs will be expensed immediately as a charge to general and administrative expenses in the consolidated statements of operations and comprehensive loss. The Company hadzero and $5.1 million deferred finance issuance costs capitalized as of December 31,2024 and 2023, respectively, included in other assets in the consolidated balance sheets.
Property and Equipment, Net
Property and equipment are recorded at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life or the lease term. Repairs and maintenance expenditures, which are not considered improvements and do not extend the useful life of property and equipment, are expensed as incurred. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheets and the resulting gain or loss is reflected in the consolidated statements of operations and comprehensive loss in the period realized.
The estimated useful lives of property, plant and equipment are as follows (in years):
| Category | Useful Life |
|---|---|
| Laboratory equipment | 5 |
| Leasehold improvements | lesser of useful life or the lease term |
| Computer equipment and software | 3-5 |
| Furniture and fixtures | 3-5 |
Leases
The Company determines whether an arrangement is or contains a lease at the inception of the arrangement and whether such a lease should be classified as a financing lease or operating lease at the commencement date of the lease. Operating leases with a term greater thanone year are recognized on the consolidated balance sheets as operating right-of-use asset (“ROU asset”) and operating lease liabilities. We elected not to recognize the right-of-use assets and lease liabilities for leases with lease terms of one year or less (short-term leases). Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the lease term. The Company considers the lease term to be the noncancelable period that it has the right to use the underlying asset, together with any periods where it is reasonably certain it will exercise an option to extend (or not terminate) the lease. As the interest rate implicit in the Company’s lease contracts is not readily determinable, the Company utilizes its incremental borrowing rate based on the information available at the commencement date to determine the present value of lease payments.
Operating lease cost is recognized on a straight-line basis over the lease term. The Company has elected to not separate lease and non-lease components for its real estate leases and instead accounts for each separate lease component and the non-lease components associated with that lease component as a single lease component. Variable lease payments are recognized as incurred.
As of December 31, 2024 and 2023, the Company hadno finance leases.
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. Recoverability is measured by comparing the carrying amount to the future undiscounted net cash flows which the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the projected discounted future net cash flows generated by the assets.
Redeemable Convertible Preferred Stock
The Company records redeemable convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The redeemable convertible preferred stock are recorded outside of permanent equity because while it is not mandatory, redemption is contingent upon the occurrence of certain events considered not solely within the Company’s control. The Company has not adjusted the carrying values of the redeemable convertible preferred stock to the liquidation preferences of such units because it is uncertain whether or when a deemed liquidation event would occur that would obligate the Company to pay the liquidation preferences to holders of redeemable convertible preferred units. Subsequent adjustments to the carrying values to the liquidation preferences will be made only when it becomes probable that such a deemed liquidation event will occur.
Collaboration Arrangements and Revenue Recognition
At the inception of an agreement, the Company evaluates if an agreement is a collaborative arrangement within the scope of ASC 808, Collaborative Arrangements(“ASC 808”). For collaborative arrangements that fall within the scope of ASC 808, the Company first determines which elements of the collaboration are deemed to be a performance obligation with a customer within the scope of ASC Topic 606, Revenue from Contracts with Customers(“ASC 606”). For elements of collaboration arrangements that are accounted for pursuant to ASC 808 and are not subject to the guidance in ASC 606, the Company applies the revenue recognition model under ASC 606 or other guidance, as deemed appropriate.
The Company re-evaluates whether the license agreement continues to be a collaborative arrangement, or whether the license agreement becomes a collaborative arrangement, whenever there is a change in either the roles of the participants in the arrangement or the participants’ exposure to significant risks and rewards dependent on the ultimate commercial success of the endeavor.
Under ASC 606, the Company recognizes revenue when the Company’s customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods and services. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as the Company satisfies a performance obligation.
The Company’s revenue is primarily derived through its license, research, development and option agreements. These agreements may include the following types of promised goods or services: (i) grants of licenses; (ii) performance of research and development services; and (iii) participation on joint research and/or development committees. They also may include options to obtain licenses to the Company’s intellectual property or to extend the term of the research activities. Payments to the Company under these arrangements typically include one or more of the following: non-refundable upfront payments; reimbursement for research services; research, development or regulatory milestone payments; profit-sharing arrangements; and royalty and commercial sales milestone payments. The event-based milestone payments, royalties and cost reimbursements represent variable consideration. The Company evaluates the probability that the event-based milestones will be achieved and estimates the amount to be included in the transaction price using the most likely amount method. The Company includes cost reimbursement in the transaction price using the expected value method.
A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606. The Company allocates the total transaction price, including variable consideration that is not constrained, to each performance obligation based on the estimated standalone selling price and recognizes revenue when, or as, the performance obligation is satisfied. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. At the end of each reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.
The Company’s collaboration and license agreements include contingent payments related to sales-based milestones and royalties. Sales-based milestones and royalties are typically payable when annual sales of a covered product reach specified levels and sales occur. When intellectual property license is determined to be a predominant promise in the arrangement, sales-based milestones and royalties are recognized at the later of when the associated performance obligation has been satisfied or when the sales occur. Unlike other contingency payments, such as regulatory milestones, sales-based milestones and royalties are not included in the transaction price based on estimates at the inception of the contract, but rather, are included when the sales or usage occur.
In cases when upfront payment contains a material right for the optional services the Company may provide in the future, the material right is treated as a separate performance obligation. The value allocated to such material right is deferred and recognized as revenue when the performance obligation is satisfied, and the optional services are provided, or when the right expires.
Contract Assets and Contract Liabilities
A contract asset is a right to consideration in exchange for goods or services that the Company has transferred to a customer when that right is conditional and is not just subject to the passage of time. A receivable is recorded on the consolidated balance sheets when the Company has unconditional rights to consideration.
A contract liability is an obligation to transfer goods or services for which the Company has received consideration, or for which an amount of consideration is due from the customer. Contract liabilities consist of deferred revenue and relate to amounts invoiced to, or advance consideration received from, licensees that precede the Company’s satisfaction of the associated performance obligations. The Company’s deferred revenue primarily results from upfront payments received relating to the performance obligations that are satisfied over time under the Company’s revenue arrangements.
The Company’s contract balances are reported in a net contract asset or liability position on a contract-by-contract basis at the end of each reporting period. Changes in the contract assets and the contract liabilities balances during the period are the result of the issuance of invoices, receipts of non-refundable upfront payments and recognition of deferred revenues.
Research and Development Expenses
Research and development costs are expensed as incurred. Research and development costs include salaries, stock-based compensation, and benefits for employees performing research and development activities, an allocation of facility and overhead expenses, expenses incurred under agreements with consultants, third-party organizations and vendors that conduct research and pre-clinical activities, regulatory support activities, manufacturing process development activities and provide supplies. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and recorded in prepaid expenses and other current assets, and then expensed as the related goods are delivered or the services are performed.
Research and development expenses accruals are estimated based on the level of services performed, progress of the work orders, including the phase or completion of events, and contracted costs. The estimated costs of research and development services provided, but not yet invoiced, are included in accrued expenses and other current liabilities in the consolidated balance sheets. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accrual accordingly. To date, there have been no material differences between estimates of such expenses and the amounts actually incurred.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty of the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses in the consolidated statements of operations and comprehensive loss.
Stock-Based Compensation Expense
Prior to the Reorganization, the Company’s equity awards included issuance of profits interests under the 2019 Equity Incentive Plan. Profits interests are a separate class of equity with defined rights within the LLC Agreement. A profits interest is an interest in the increase in the value of the Company over the threshold amount, as determined at the time of grant on a per unit basis. The threshold amount was based on the valuation of the common units on or around the grant date.
The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation(ASC 718). In accordance with ASC 718, compensation expense is measured based on the estimated grant date fair value and is recognized as compensation expense on a straight-line basis over the requisite service period (usually the vesting period). Forfeitures are accounted for as they occur. Stock-based compensation expense is recorded as either research and development or general and administrative expenses in the consolidated statements of operations and comprehensive loss based on the function to which the related services are provided.
The grant date fair value of restricted stock units is based on the closing price of the Company’s common stock on the date of grant. The Company estimates the grant date fair value of stock options issued subsequent to the IPO and profits interests units issued prior to July 31, 2023 using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the use of several variables and assumptions that require judgment, as discussed below.
Expected volatility—Expected volatility is estimated based on the historical volatility of a publicly traded set of peer companies over a period equal to the expected term, as the Company does not have sufficient trading history for its own common stock. Beginning in 2024, expected volatility also takes into consideration the Company’s own historical volatility since its IPO. The comparable companies were chosen based on the similar size, stage in the life cycle, or area of specialty. The Company will continue to apply this process until adequate historical data regarding the volatility of its own stock price becomes available.
Expected term—The expected term represents the period that stock-based awards are expected to be outstanding. Prior to the IPO, the expected term of profits interests was determined based on the expected time to liquidity and expected vesting term. After the completion of the IPO, the Company’s historical stock option exercise information is limited due to a lack of sufficient data points and therefore does not provide a reasonable basis upon which to estimate expected term. The Company has elected to use the simplified method for estimating the expected term, which is calculated as the mid-point between the vesting date and the contractual term.
Risk-free interest rate—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.
Dividends—Expected dividend yield iszero as the Company has never paid cash dividends and has no intention to pay cash dividends for the foreseeable future.
Fair Value of Common Stock and Common Units—After completion of the IPO, the fair value of common stock is based on the closing market price on the date of grant. Prior to the IPO, because there had been no public market for the Company’s common units, the fair value of common units was determined as further discussed below in “Fair Value of Common Units.”
Fair Value of Common Units—The grant date fair value of common units issued prior to July 31, 2023 utilized in the Black-Scholes model was determined by the Company’s Board of Managers with the assistance of management. The grant date fair value of common units was determined using valuation methodologies which utilizes certain assumptions including probability weighting of expected exit events, volatility, time to liquidation, a risk-free interest rate and an assumption for a discount for lack of marketability. After giving the effect to the Amendment to the LLC Agreement, the grant date fair value of profits interests issued and modified after July 31, 2023 was estimated using the valuation model based on the Probability Weighted Expected Return Method (“PWERM”). The estimated equity fair value was allocated via the distribution waterfall in accordance with the Amendment to the LLC Agreement to all outstanding redeemable convertible preferred units, common units and profits interests. The PWERM is the hybrid method, where the equity value in one or more scenarios is calculated using an option pricing model. The PWERM is a scenario based methodology that estimates the fair value of common units based upon an analysis of future values for the company, assuming various outcomes. The common unit value is based on the probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of members’ units. The future value of the common unit under each outcome is discounted back to the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common unit. A discount for lack of marketability of the common unit is then applied to arrive at an indication of value for the common unit. In determining the fair value of the common units, the methodologies used to estimate the enterprise value were performed using methodologies, approaches, and assumptions consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.
Metagenomi uses the asset and liability method to account for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement carrying amounts of existing assets and liabilities and their tax bases. Deferred tax assets and liabilities are measured using enacted tax rates applied to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. Metagenomi assesses the likelihood of deferred tax assets being realized. It provides a valuation allowance when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible.
Tax benefits related to uncertain tax positions are recognized when it is more likely than not that a tax position will be sustained during an audit. Tax positions that meet the more-likely-than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon settlement with the taxing authority. Interest and penalties related to unrecognized tax benefits are included within the provision for income tax.
Net Loss Per Share
The Company calculates basic and diluted net loss per share in conformity with the two-class method required for participating securities. Under the two-class method, basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of common shares outstanding during the period plus the dilutive effects of potentially dilutive securities outstanding during the period. Potentially dilutive securities include common stock issuable upon conversion of redeemable convertible preferred stock, common stock issuable upon settlement of profits interests, shares of restricted stock subject to future vesting, options to purchase common stock, and restricted stock units outstanding. For all periods presented, diluted net loss per share is the same as basic net loss per share since the effect of including potential dilutive securities is anti-dilutive. In connection with the Reorganization and in accordance with ASC 260, Earnings Per Share, the conversion of common units has been retrospectively reflected in the Company’s net loss per share calculation, see Note 14.
Comprehensive Loss
Comprehensive loss is defined as a change in equity of a business enterprise during a period resulting from transactions from non-owner sources. Comprehensive loss is comprised of net loss and other comprehensive income (loss). The Company’s other comprehensive income (loss) consists of unrealized gains (losses) on available-for-sale marketable securities. The Company has not recorded any reclassifications from other comprehensive income (loss) to net loss during the periods presented.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted ASU 2023-07 on December 31, 2024. Refer to Note 12, Segment Reporting, for disclosures related to the adoption of ASU 2023-07.
Recently Issued Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of the adoption of this standard on its financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires, among other things, more detailed disclosures about specified categories of expense (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. This ASU may be applied prospectively with the option for retrospective application. The Company is currently evaluating the impact of the adoption of this standard on its financial statements.
Fair Value Measurements
The following tables summarize financial assets that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Money market funds (included in cash and cash equivalents) | $26,169 | $26,169 | $— | $— |
| U.S. government bonds | 109,657 | — | 109,657 | — |
| Government agency obligations | 40,544 | — | 40,544 | — |
| Corporate debt obligations | 32,353 | — | 32,353 | — |
| Commercial paper | 30,349 | — | 30,349 | — |
| Asset-backed securities | 5,520 | — | 5,520 | — |
| Foreign debt securities | 2,498 | — | 2,498 | — |
| Long-term investments (Note 5) | 1,292 | — | — | 1,292 |
| Total fair value of assets | $248,382 | $26,169 | $220,921 | $1,292 |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Money market funds (included in cash and cash equivalents) | $137,216 | $137,216 | $— | $— |
| U.S. treasury bills | 9,831 | — | 9,831 | — |
| U.S. government bonds | 2,989 | — | 2,989 | — |
| Government agency obligations | 46,409 | — | 46,409 | — |
| Corporate debt obligations | 10,973 | — | 10,973 | — |
| Commercial paper | 54,727 | — | 54,727 | — |
| Asset-backed securities | 2,171 | — | 2,171 | — |
| Foreign debt securities | 3,479 | — | 3,479 | — |
| Long-term investments (Note 5) | 8,521 | — | — | 8,521 |
| Total fair value of assets | $276,316 | $137,216 | $130,579 | $8,521 |
In addition, restricted cash of$5.2 million as of December 31, 2024 and 2023, collateralized by the Company’s cash equivalents, are financial assets measured at fair value and are Level 1 financial instruments under the fair value hierarchy.
Given the challenging financing environment for cell therapy companies in early clinical development as well as recent updates provided by Affini-T management, the Company determined the need to assess the equity value of its investments in Affini-T on December 31, 2024 considering potential alternative outcomes under a hybrid method. Thehybrid method is a hybrid between the probability-weighted expected returns method (the “PWERM”) and theoption-pricing model backsolve method (the “OPM”). Using the PWERM, the equity value under scenarios including the sale of the company, the liquidation of the company, and the company continuing as a going concern, were weighted based on an estimate of the probability of each event occurring. The going concern analysis was done by applying the OPM for inferring the total equity value implied by the Series B preferred stock financing round of Affini-T. Key assumptions used in the OPM as of December 31, 2024 included an expected holding period oftwo years, a risk free interest rate of 4.05%, a dividend yield of 0.0% and an estimated volatility of 88.5%. Key assumptions used in the valuation model as of December 31, 2023 included an expected holding period oftwo years, a risk free interest rate of 4.87%, a dividend yield of 0.0% and an estimated volatility of 83.0%. Estimated volatility was calculated based on the historical volatility of a selected peer group of public companies comparable to Affini-T.
The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial assets (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Beginning balance | $8,521 | $5,651 |
| Fair value of investment received as collaboration consideration | 1,632 | — |
| Fair value of investment purchased in preferred stock purchase agreement | 324 | — |
| Change in fair value included in other income (expense) | (9,185) | 2,870 |
| Ending balance | $1,292 | $8,521 |
Marketable Securities
The following tables summarize the amortized cost, unrealized gains (losses) and fair value of available-for-sale marketable securities (in thousands):
| AmortizedCost | UnrealizedGains | UnrealizedLosses | Fair Value | |
|---|---|---|---|---|
| Money market funds | $26,169 | $— | $— | $26,169 |
| U.S. government bonds | 109,096 | 562 | (1) | 109,657 |
| Government agency obligations | 40,435 | 109 | — | 40,544 |
| Corporate debt obligations | 32,352 | 37 | (36) | 32,353 |
| Commercial paper | 30,324 | 31 | (6) | 30,349 |
| Asset-backed securities | 5,507 | 13 | — | 5,520 |
| Foreign debt securities | 2,498 | — | — | 2,498 |
| Total | 246,381 | 752 | (43) | 247,090 |
| Less: amounts classified as cash equivalents | (26,169) | — | — | (26,169) |
| Total available-for-sale marketable securities | $220,212 | $752 | $(43) | $220,921 |
| AmortizedCost | UnrealizedGains | UnrealizedLosses | Fair Value | |
|---|---|---|---|---|
| Money market funds | $137,216 | $— | $— | $137,216 |
| U.S. Treasury bills | 9,826 | 5 | — | 9,831 |
| U.S. Government bonds | 3,005 | — | (16) | 2,989 |
| Government agency obligations | 46,446 | 4 | (41) | 46,409 |
| Corporate debt obligations | 11,014 | — | (41) | 10,973 |
| Commercial paper | 54,724 | 4 | (1) | 54,727 |
| Asset-backed securities | 2,177 | — | (6) | 2,171 |
| Foreign debt securities | 3,484 | — | (5) | 3,479 |
| Total | 267,892 | 13 | (110) | 267,795 |
| Less: amounts classified as cash equivalents | (137,216) | — | — | (137,216) |
| Total available-for-sale marketable securities | $130,676 | $13 | $(110) | $130,579 |
As of December 31, 2024 and 2023, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the issuers of the available-for-sale securities, and the Company has no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. The Company considered the current and expected future economicand market conditions and determined that its investments were not significantly impacted. For all securities with a fair value less than its amortized cost basis, the Company determined the decline in fair value below amortized cost basis to be immaterial and non-credit related, and thereforeno allowance for losses has been recorded. During the years ended December 31,2024 and 2023, the Company didnot recognize any impairment losses on its investments.
Accrued interest receivable included in prepaid expenses and other current assets as of December 31, 2024 and 2023 was$1.6 million and$1.0 million, respectively. The company hasnot written off any accrued interest receivable during the years ended December 31,2024 and 2023.
The amortized cost and fair value of available-for-sale marketable securities by contractual maturity were as follows (in thousands):
| December 31, 2024 | December 31, 2023 | |||
|---|---|---|---|---|
| AmortizedCost | Fair Value | AmortizedCost | Fair Value | |
| Maturing within one year | $153,484 | $153,893 | $129,823 | $129,728 |
| Maturing in one to five years | 66,728 | 67,028 | 853 | 851 |
| Total available-for-sale marketable securities | $220,212 | $220,921 | $130,676 | $130,579 |
Long-Term Investments
Affini-T investment
In July 2024, pursuant to the terms of the Development, Option and License Agreement with Affini-T (the “Affini-T Agreement”), the Company received equity consideration of 933,650 shares of Affini-T common stock upon the achievement of a regulatory milestone related to the submission of drug master files to the Food and Drug Administration (“FDA”) in support of an investigational new drug (“IND”) application for Affini-T’s T-cell receptor-based therapy. Refer to Note 7 for further discussion of the Affini-T Agreement to perform research and development activities.
In August 2024, in connection with Affini-T’s Series B extension, the Company entered into a Joinder to Series B Preferred Stock Purchase Agreement (the “Series B Purchase Agreement”), pursuant to which the Company purchased 33,383 shares of Series B convertible preferred stock of Affini-T (the “Affini-T Series B Preferred Stock”) at a purchase price of $9.714 per share and received warrants to purchase up to 16,691 shares of common stock at an exercise price of $0.01 per share, for an aggregate purchase price of approximately $0.3 million. The Series B Purchase Agreement also provides for the purchase of up to an additional 16,691 shares of Affini-T Series B Preferred Stock at a purchase price of $9.714 per share and warrants to purchase up to 8,345 shares of common stock at an exercise price of $0.01 per share in a subsequent milestone closing (the “Milestone Closing”), upon Affini-T achieving certain milestone conditions. The Milestone Closing has not occurred as of December 31, 2024.
As of December 31, 2024, the Company had investments in Affini-T consisting of 527,035 shares of Series A convertible preferred stock,33,383 shares of Series B Preferred Stock,1,867,300 shares of common stock, and a warrant exercisable for 16,691 shares of common stock. As of December 31,2023, the Company had investments in Affini-T consisting of 527,035 shares of Series A convertible preferred stock and 933,650 shares of common stock. The Company performed a VIE analysis and concluded that it was not a primary beneficiary of Affini-T as of December 31,2024 and 2023.
The Company is using the fair value method to account for its investments in Affini-T (see Note 3) with changes in fair value recorded to other income (expense) in the consolidated statements of operations and comprehensive loss. The estimated fair value of its investments in Affini-T was$1.3 million and$8.5 million as of December 31, 2024 and 2023, respectively. The Company recognized a loss related to the change in fair value of$9.2 million during the year ended December 31, 2024, and recognized a gain related to the change in fair value of$2.9 million during the year ended December 31, 2023.
ViTToria investment
As of December 31, 2024 and 2023, the Company had an investment in shares of preferred stock of ViTToria Biotherapeutics, Inc. (“Vittoria”), a private biotechnology company. During the years ended December 31, 2024 and 2023, the Company did not have a board seat and owned less than 20% of the outstanding voting shares of Vittoria. The investment in Vittoria does not provide the Company the ability to control or have significant influence over Vittoria’s operations. The Company accounts for its investment in Vittoria using the measurement alternative method. As of December 31,2024 and 2023, the carrying value of Vittoria’s investment was $2.2 million andno impairment was recognized.
Consolidated Balance Sheets Components
Property and equipment, net consists of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Laboratory equipment | $23,080 | $20,777 |
| Leasehold improvements | 4,375 | 3,831 |
| Computer equipment and software | 1,068 | 648 |
| Furniture and fixtures | 343 | 374 |
| Construction in progress | 143 | 2,346 |
| Total property and equipment | 29,009 | 27,976 |
| Less: Accumulated depreciation | (11,269) | (6,434) |
| Total property and equipment, net | $17,740 | $21,542 |
Depreciation expense was$5.4 million and$4.2 million for the years ended December 31, 2024 and 2023, respectively.
Accrued expenses and other current liabilities consist of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Accrued personnel related expenses | $5,346 | $7,263 |
| Accrued legal and professional services | 931 | 2,627 |
| Accrued research and development expenses | 1,625 | 856 |
| Accrued purchases of property and equipment | 74 | 445 |
| Other accrued liabilities | 446 | 281 |
| Total accrued expenses and other current liabilities | $8,422 | $11,472 |
Significant Agreements
Moderna strategic collaboration and license agreement
On October 29, 2021, the Company entered into a Strategic Collaboration and License Agreement with ModernaTX, Inc. (“Moderna”) (the “Moderna Agreement”). On April 26, 2024, the Company and Moderna mutually terminated the Moderna Agreement (the “Termination”). The Moderna Agreement was terminated pursuant to a Mutual Termination Agreement (the “Termination Agreement”), dated as of April 26, 2024, by and between the Company and Moderna. Pursuant to the Termination Agreement, the Company regained full development and commercialization rights to its wholly-owned base editing and RNA-mediated integration systems (“RIGS”) that were subject to the Moderna Agreement.
Prior to the Termination, the parties collaborated on the research and development of in vivo genome editing therapies directed at certain targets and the commercialization of such genome editing therapies. The collaboration provided Moderna with exclusive access to the Company’s technology platform during the research period in (1) the field of in vivo genome editing technology for a therapeutic, ameliorative or prophylactic application by way of knock-out through InDel formation or base editing or insertion of an exogenous DNA template (such field, “DT Field”) and (2) the field of in vivo genome editing technology for a therapeutic, ameliorative or prophylactic application outside the use of (a) DNA donor templates and (b) no exogenous template at all but including (c) correction by base editing (such field, “RT Field”). The use of RIGS with messenger RNA (“mRNA”) and base editing correction with mRNA was within the RT Field exclusive to Moderna within the term. The parties formed a joint steering committee, a joint research subcommittee and a joint patent subcommittee to oversee the collaboration activities. Under the terms of the Moderna Agreement, the parties agreed to collaborate on one or more programs in the RT Field (the “Moderna RT program”) and two programs in the DT Field (the “Moderna DT program” and the “DT Co-Co program”).
With respect to the Moderna RT program and Moderna DT program, the parties agreed to collaborate on the research and development of product candidates under the approved research plans. The initial research term of the Moderna RT program wasfour years, which could have been extended by Moderna for an additional three years upon written notice and a payment of extension fees. The initial research term of the Moderna DT program wasfour years. The Company granted Moderna an option to obtain an exclusive license to develop, manufacture and commercialize up to ten Moderna RT program candidates and up to two Moderna DT program candidatesat any time during the research term and prior to filing of an IND application with the FDA or any similar application filed with a regulatory authority in a country other than the U.S., subject to Moderna’s payment of an option exercise fee of $10.0 million per target.
With respect to the DT Co-Co program, the parties agreed to work together on the co-development and commercialization of products and shared costs and profits equally. The Company maintained commercialization rights in the U.S. (subject to Moderna’s right to appoint up to 50% of the U.S. sales force for the DT Co-Co program), while Moderna maintained these rights in countries other than the U.S. The initial research term for the DT Co-Co program wasfour years, and each party had a right to opt-out of the DT Co-Co program at any time, at which point the other party had the right to solely continue the development and commercialization activities. If there was no development candidate nomination by the end of the initial research term, the DT Co-Co program would have expired, unless the parties had mutually agreed to continue the program.
During the year ended December 31, 2021, the Company received a non-refundable upfront payment of $40.0 million and a $5.0 million payment for the first year of research costs. Concurrent with the Moderna Agreement, Moderna also provided $30.0 million in cash in the form of a convertible promissory note pursuant to a convertible promissory note agreement dated October 29, 2021 (the “Moderna Convertible Promissory Note Agreement”). The convertible promissory note was converted into shares of Series B redeemable convertible preferred units in January 2022. Moderna reimbursed the Company up to $5.0 million in annual research and development costs related to the Moderna RT program and Moderna DT program, or up to the agreed amount of expenses per the budget. As of December 31,2024, the Company has received a total of$56.6 million under the Moderna Agreement, not including cost-sharing payments under the DT Co-Co program.
For the Moderna RT program and Moderna DT program, the Company was eligible to receive (i) technology milestone fees related to the achievement of certain preclinical research objectives, of up to $75.0 million, (ii) development and regulatory milestones of up to $100.0 million per target, (iii) sales milestones of up to $200.0 million per target and (iv) royalties ranging from a mid-single digit to a low-teens percentage of annual net sales of a licensed product. Any profits and losses from the co-development and commercialization of the DT Co-Co program were shared equally between the Company and Moderna. With respect to the DT Co-Co program for which the opt-out party had exercised its opt-out right, the continuing party would have paid to the opt-out party, certain development, regulatory and sales milestone payments that would not have exceeded an aggregate $239.0 million per DT Co-Co target, and opt-out royalties ranging from a high-single digit to a low-teens percentage of annual net sales of a licensed product.
The Company concluded that the Moderna RT program and Moderna DT program are in the scope of ASC 606. The Company determined that the licenses granted to Moderna, and its participation in the joint steering committee are not capable of being distinct from the preclinical research and development services and therefore concluded that there are two performance obligations: (1) the Moderna RT program and (2) the Moderna DT program. The Company also concluded that the option to obtain an exclusive license and options to extend the Moderna RT program term do not include significant incremental discounts, and as such, the options do not provide material rights.
The Company concluded that the DT Co-Co program research activities are within the scope of ASC 808, as the Company and Moderna were both active participants in the research, development and commercialization activities, were exposed to significant risks and rewards that were dependent on the success of the DT Co-Co program activities and share costs and profits equally. The Company determined that the guidance in ASC 730, Research and Development, was appropriate to apply to the DT Co-Co program research activities by analogy, based on the nature of the cost sharing provisions of the agreement. The Company concluded that DT Co-Co program is one unit of accounting, as the co-exclusive license is not distinct from the research and development and the participation in joint steering committee activities. The Company recognized payments to or from Moderna related to the DT Co-Co program cost sharing research activities as an increase to or reduction of research and development expenses, respectively.
The Company concluded that the Moderna Agreement and the Moderna Convertible Promissory Note Agreement should be combined and treated as a single arrangement for accounting purposes as the agreements were entered into contemporaneously and in contemplation of one another. The Company estimated the contract consideration to be $90.0 million, which consisted of: 1) the non-refundable upfront collaboration payment of $40.0 million received in 2021, 2) $30.0 million in cash received in 2021 in exchange for the convertible promissory note and 3) the estimated cost reimbursements for the Moderna RT program and Moderna DT program of $20.0 million. The Company constrained future milestones, as it assessed that it was probable that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. During the year ended December 31, 2021, the Company recorded $30.0 million of the contract consideration for the convertible promissory note based on the fair value and allocated the transaction price of $60.0 million to each of the following programs on a relative standalone selling price basis: 1) $49.5 million to the Moderna RT program, 2) $5.5 million to the Moderna DT program and 3) $5.0 million to the DT Co-Co program.
Thevariable consideration is reevaluated at each reporting period and as changes in circumstances occur. The Company recognized revenuefor each of the Moderna RT program and Moderna DT program as collaboration revenue based on the measure of progress using an estimated cost-based input method each reporting period. The Company also amortized the allocation consideration for the DT Co-Co program of $5.0 million as a credit to research and development expenses during the discovery and lead optimization phases for the DT Co-Co program.
Due to the Termination of the Moderna Agreement, the Company recognized all remaining deferred revenue as revenue during the year ended December 31, 2024. The final $5.0 million payment related to the fourth year of research costs was forfeited. The Company recognized collaboration revenue of$18.7 million and$18.1 million in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023, respectively, which was included in deferred revenue as of December 31, 2023 and 2022, respectively. During the year ended December 31, 2024, the Company recognized$0.1 million and$0.7 million in credits to research and development expenses related to the cost sharing allocation and amortization of the collaboration advance, respectively. During the year ended December 31, 2023, the Company recognized$0.3 million and$0.4 million in credits to research and development expenses related to the cost sharing allocation and amortization of the collaboration advance, respectively.
As of December 31, 2024, there wereno remaining unsatisfied performance obligations. As of December 31,2024 and 2023, the accounts receivable balance waszero and $0.5 million, respectively, the deferred revenue balance waszero and$18.7 million, respectively, and the collaboration advance balance waszero and $0.8 million, respectively.
Affini-T development, option and license agreement
Pursuant to the Affini-T Agreement entered into on June 14, 2022, the parties have agreed to identify, develop or optimize certain reagents using the Company’s proprietary technology for Affini-T to use such reagents to develop and commercialize gene edited T-cell receptor (“TCR”)-based therapeutic products exclusively in the field of treatment, prevention or diagnosis of any human cancer using products with any engineered primary TCR alpha/beta T cells and non-exclusively in the field of treatment, prevention or diagnosis of any human cancer using products with certain other engineered immune cells worldwide. A joint steering committee was established by both parties to assign alliance managers and project leaders to oversee the collaboration activities.
Pursuant to the Affini-T Agreement, the Company granted Affini-T options to receive, on a pre-specified target-by-pre-specified target basis, for up to six pre-specified targets, either (i) an exclusive, royalty-bearing, sublicensable worldwide license under all of the Company’s applicable intellectual property to research, develop, manufacture, use, commercialize and otherwise exploit any TCR-based therapy, preventative treatment, or diagnostic for humans that is directed to such pre-specified target, contains or comprises Primary TCR alpha/beta T Cells and is derived from ex vivo application of a Company reagent (the “Exclusive Option”) or (ii) a non-exclusive, royalty-bearing, sublicensable worldwide license under all of the Company’s applicable intellectual property to research, develop, manufacture, use, commercialize and otherwise exploit any TCR-based therapy, preventative treatment, or diagnostic for humans that is directed to such pre-specified target, contains or comprises TCR natural killer (“NK”) cells derived from iPSC immune cells or TCR T cells derived from donor-derived or iPSC immune cells. Affini-T can exercise its options for either an exclusive license or a non-exclusive license, or both, for each pre-specified target by providing written notice prior to the earlier of (x) the end of the Affini-T Agreement term or (y) 90 days following the filing of an IND for a licensed product directed to a pre-specified target, subject to the payment of certain fees per each option exercised. After the option exercise, Affini-T has agreed to use commercially reasonable efforts to conduct all development and commercialization activities for a licensed product, and development and commercialization of all licensed products will be at Affini-T’s sole cost and expense.
In connection with the Affini-T Agreement, the Company received upfront equity consideration of 719,920 shares of Affini-T’s common stock with an estimated fair value of $1.3 million in June 2022. Upon achievement of a regulatory milestone in July 2024 related to the submission of drug master files to the FDA in support of an IND for Affini-T’s T-cell receptor-based therapy, the Company received additional equity consideration of 933,650 shares of Affini-T common stock with an estimated fair value of $1.6 million in July 2024. The fair value of Affini-T’s shares of common stock was estimated by management, considering the most recent third-party valuation at the time of each grant. Affini-T has also agreed to reimburse the Company for expenses incurred while performing research activities under the research plans. As of December 31,2024, the Company has received a total of$7.5 million from Affini-T related to reimbursable expenses. Additionally, the Company is eligible to receive (i) up to $18.8 million in future developmental milestone payments depending on the completion of or the number of patients dosed in, the relevant human clinical trial, or the initiation of a pivotal trial, and $40.6 million in future regulatory approval milestone payments, which include regulatory approvals in the U.S. and other markets for licensed products directed to a pre-specified target if options for both exclusive and non-exclusive licenses are exercised with respect to such target, (ii) up to $250.0 million in sales-based milestones for aggregate sales of all licensed products directed to a given pre-specified target and (iii) royalties ranging from a low-single digit to high-single digit percentage of worldwide annual net sales of licensed products.
Theinitial term of the Affini-T Agreement is five years from the effective date. If Affini-T exercises an Exclusive Option with respect toany pre-specified target during the initial term, the initial term will be extended by an additional five years. Following the expiration of the extended term, if any, the agreement will continue on a target-by-target basis and expire with respect to such target upon the expiration of the royalty term for all licensed products directed to such target. The Affini-T Agreement may be terminated during the term by either party for an uncured material breach by, or bankruptcy of, the other party. Additionally, Affini-T may terminate the Affini-T Agreement for convenience, in its entirety, on a research plan-by-research plan basis, on a target-by-target basis or on a licensed product-by-licensed product basis, by providing prior written notice.
The Company concluded that the Affini-T Agreement is in the scope of ASC 606 and that there is one performance obligation to perform research activities under the Affini-T Agreement. Exclusive and non-exclusive licenses are optional contingent purchases that do not include significant incremental discounts, and therefore do not provide a material right.
At the effective date, the transaction price consisted of the upfront equity consideration with an estimated fair value of $1.3 million and estimated research reimbursement costs. Research reimbursement costs represent variable consideration, and the Company’s management estimates what portion to include in total consideration at the end of each reporting period. Other payments under the Affini-T Agreement, including additional equity consideration and development and regulatory milestones, also represent variable consideration, and were constrained at the effective date to the extent that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. In June 2023, the joint steering committee approved the budget for estimated research reimbursement costs for the Affini-T Agreement, which resulted in a $2.4 million reduction to variable consideration. In July 2024, the Company included previously constrained additional equity consideration related to the regulatory milestone with an estimated fair value of $1.6 million in the transaction price, resulting in an increase to variable consideration. As of December 31,2024 and 2023, future development and regulatory milestone payments were excluded from the estimated total transaction price as they were considered constrained. In addition, the equity consideration related to the regulatory milestone was also excluded from the estimated total transaction price as of December 31, 2023, as it was also considered constrained. The transaction price is reevaluated in each reporting period and as changes in circumstances occur. The Company recognizes revenue each reporting period based on the measure of progress using an estimated cost-based input method.
The Company recognized collaboration revenue of$3.1 million and$4.7 million in the consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and 2023, the accounts receivable balance was$0.2 million and$2.0 million, respectively, related to services performed. There was no contract asset related to services performed as of December 31, 2024 and 2023. As of December 31, 2024 and 2023, deferred revenue related to the Affini-T Agreement was$0.2 million. The value of the transaction price allocated to the remaining unsatisfied portion of the performance obligation was approximately$0.8 million as of December 31, 2024, which the Company expects to recognize as revenue over the next four-to-five years.
Ionis collaboration and license agreement
On November 10, 2022 the Company entered into a Collaboration and License Agreement with Ionis Pharmaceuticals, Inc. (“Ionis”) (the “Ionis Agreement”) to collaborate on drug discovery and exploratory research activities to advance new medicines using genome editing strategies, with the goal of discovering novel medicines. Pursuant to the terms of the Ionis Agreement, the Company granted Ionis and its affiliates a worldwide exclusive, royalty-bearing license, with the right to grant sublicenses, to use all licensed systems and licensed products in the field of in vivo genome editing for all therapeutic, prophylactic, palliative, and analgesic uses in humans. In connection with the Ionis Agreement, the Company also has the right to exercise an exclusive option to co-develop and co-commercialize certain products under a drug discovery program. A joint steering committee was established by both parties to coordinate, oversee and monitor the research and drug discovery activities under the Ionis Agreement.
The parties will collaborate to discover therapeutic products under a drug discovery program and develop a drug discovery plan for each target, selected by Ionis. The target selection is divided into two waves: up to four targets in Wave 1 and up to four targets in Wave 2. For each drug discovery program, once the parties identify a development candidate that is suitable for further development, Ionis will be responsible for the development and commercialization of products resulting from such program. Per the terms of the Ionis Agreement, at any time prior to the designation of a development candidate for a drug discovery program and for any reason, Ionis may replace the collaboration target, provided such target has not previously been substituted out. Ionis may substitute (i) up to two Wave 1 targets and (ii) up to two Wave 2 targets.
The drug discovery activities for a program commence on the selection of a target and expire upon the earlier of (a) completion of all drug discovery activities for such program, (b) the fifth anniversary of the effective date and (c) selection of a development candidate for such drug discovery program. If one or more Wave 2 targets become collaboration targets as a result of the parties achieving enabled delivery and less than two years are remaining in the drug discovery term, then the term will be extended to the earlier of (i)
the time that the Company completes all of its activities under the applicable drug discovery plan and (ii) the seventh anniversary of the effective date, subject to the Company’s consent.
The parties will also conduct an exploratory research program, and will jointly optimize gRNA and select delivery technologies and other activities. The exploratory research activities commence on the effective date and expire upon the earlier of (a) completion of all exploratory research activities established in the exploratory research plan, and (b) the fifth anniversary of the effective date.
The Company has the exclusive option to co-develop and co-commercialize the licensed products under a drug discovery program (the “Co-Co Option”) with Ionis. The Co-Co Option may be exercised for (a) the initial Wave 1 target (“Target 1”), (b) no more than one of the other three discovery programs for the Wave 1 targets, and (c) no more than two drug discovery programs for the Wave 2 targets that become collaboration targets. If the Company exercises the Co-Co Option for a particular drug discovery program, that drug discovery program will automatically be deemed a “Co-Co Program”, all corresponding licensed products be deemed “Co-Co Products,” the Company will be obligated to pay Ionis an option exercise fee, and the parties will enter into a separate co-development and co-commercialization agreement. The Co-Co Option exercise fee will equal 50% of Ionis’ internal costs and out-of-pocket costs incurred in the conduct of the drug discovery activities prior to the exercise of the Co-Co Option and be reduced by 50% of the Company’s corresponding costs incurred. Future development and commercialization costs will be shared equally. The Company may elect to reduce its cost-share percentage anywhere between 50% and 25% on a go-forward basis, provided the Company will continue to bear 50% of the costs of any clinical trials ongoing at the time of the election through the completion of the clinical trials.
The Company will manufacture all licensed systems and certain components of the applicable licensed products that are needed by Ionis for use in its development activities and all of the Company’s manufactured components needed by Ionis for use in its commercialization activities. The Company will provide the manufactured components at a price that represents the cost of goods plus 15%. As of December 31,2024, the Company received a total of$0.8 million related to the manufactured components.
Pursuant to the terms of the Ionis Agreement, the Company has also been granted an option to obtain a non-exclusive, royalty-bearing license, with the right to grant sublicenses, for certain Ionis’ background technology to use in up to eight therapeutic products discovered by the Company in the field of in vivo genome editing and directed to a Collaboration Target (each such product, a “Metagenomi Product” and each such option an “Ionis IP Option”), but subject to encumbrance checks with respect to particular targets. A Collaboration Target is a target that is selected by Ionis, and, with respect to the Company is not the subject of discussions with a third party, is not the subject of a contractual grant of rights to a third party nor the subject to an internal research and development program. If the Company exercises its Ionis IP Option, the Company will pay to Ionis up to several million dollars per Metagenomi Product upon achievement of certain clinical and regulatory milestones. The Company is also obligated to pay Ionis royalties in an amount equal to a low single-digit royalty on the net sales of the applicable Metagenomi Product on product-by-product and country-by-country basis.
In November 2022, the Company received an $80.0 million upfront payment from Ionis for the Wave 1 drug discovery research collaboration and selected Target 1. Ionis selected its second target (“Target 2”) in Wave 1 in December 2022, its third target (“Target 3”) in Wave 1 in November 2023, and its fourth target (“Target 4”) in Wave 1 in February 2024. Ionis has an option to select up to four Wave 2 targets at any time during the drug discovery term, if (a) an IND for any licensed product directed to a Wave 1 target is filed with the applicable regulatory authority or (b) the parties achieve enabled delivery for a non-liver target under the exploratory research activities, by providing written notice and by paying a Wave 2 target selection fee of $15.0 million or $30.0 million, depending on and per the selected target.
Ionis is obligated to reimburse the Company for all internal costs and out-of-pocket costs incurred in the performance of the exploratory research activities, up to an aggregate of $10.0 million, which is payable in quarterly installments of $0.5 million during the exploratory research term. As of December 31,2024, the Company received a total of$4.0 million related to the reimbursable expenses. The Company is also eligible to receive (a) up to $29.0 million in future development milestone payments for each licensed product; (b) up to $60.0 million in future regulatory milestone payments for each licensed product; (c) up to $250.0 million in sales-based milestones for each licensed product; and (d) royalties on annual net sales of licensed products from a mid-single-digit to low-teens percentage, subject to customary reductions.
The term of the Ionis Agreement will continue (i) with respect to the drug discovery programs, until the expiration of all applicable royalty terms for a licensed product, (ii) with respect to the Co-Co Programs, until the parties cease all exploitation for the Co-Co Products that are the subject to such Co-Co Program, and with respect to the Metagenomi Products, until the expiration of the royalty term for a Metagenomi Product. The royalty term ends on the latest of the following two dates: (i) the expiration of (A) the last claim of any issued and unexpired patent, or (B) a claim within a patent application that has not been pending for more than seven years from the earliest date to which the claim or applicable patent application is entitled to claim priority and which claim has not been revoked, canceled, withdrawn, held invalid, or abandoned, or (ii) 12 years following the first commercial sale of a licensed product.
The Ionis Agreement may be terminated during the term by either party for an uncured material breach or bankruptcy by the other party. Additionally, Ionis may terminate the Ionis Agreement for convenience and without penalty, in its entirety or on a licensed product-by-licensed product basis, by providing 90 days’ written notice.
The Company concluded that the Ionis Agreement is in the scope of ASC 606 at the effective date and until the Company exercises its Co-Co Option for any drug discovery program, which was determined to not be probable at the effective date and as of December 31, 2024 and 2023. The Company also concluded that exclusive licenses and participation in a joint steering committee are not distinct from discovery research services and should thus be combined into one performance obligation (the “discovery program”). The Company also concluded that exploratory research services are a separate and distinct performance obligation (the “exploratory program”). The Ionis options for Wave 2 targets are optional purchases and do not have significant incremental discounts, as such, the options do not provide material rights.
The Company allocated the total estimated transaction price of $90.0 million, which consisted of an $80.0 million upfront payment received in November 2022 and $10.0 million in reimbursements for research costs, into two performance obligations, which was determined based on their estimated standalone selling prices. The Company concluded that future development and commercial supply agreements are at market terms, as the terms were consistent with industry standards as of the effective date. The Company constrains future milestone payments under the arrangement to the extent that the inclusion of such variable consideration could result in a significant reversal of cumulative revenue in future periods. The Company constrained all development and regulatory milestone payments at the effective date and as of December 31,2024 and 2023. The Company is recognizing revenue of $80.0 million related to the discovery program and $10.0 million related to exploratory program over the research terms using an estimated cost-based input method as a measure of progress for each obligation.
In June 2024, the Company included previously constrained estimated manufacturing costs in the transaction price, resulting in a $3.4 million increase to variable consideration. The Company recognized collaboration revenue of$30.4 million and$21.9 million for the years ended December 31, 2024 and 2023, respectively, of which$26.6 million and$21.9 million, respectively, was included in deferred revenue as of December 31, 2023 and 2022. As of December 31, 2024 and 2023, deferred revenue related to the Ionis Agreement was$32.8 million and$60.0 million, respectively. As of December 31, 2024 and 2023, the accounts receivable balance was$1.1 million andzero, respectively. The value of the transaction price allocated to the remaining performance obligations was approximately$41.2 million as of December 31, 2024, which the Company expects to recognize as revenue over the next three years.
Commitments and Contingencies
Operating leases
In January 2021, the Company entered into aten-year operating lease for laboratory and office space in Emeryville, California. The lease commencement date was in February 2021. In conjunction with signing this lease, the Company secured a letter of credit. As of December 31,2024 and 2023, the balance of this letter of credit was $2.5 million and is recorded as noncurrent restricted cash in the consolidated balance sheets. The lease agreement includes a renewal provision allowing the Company to extend this lease for an additional five years, which the Company is not reasonably certain to exercise.
In September 2021, the Company entered into a 9.25-year operating lease for office space in Emeryville, California, with a lease commencement date in November 2021. In conjunction with signing the lease, the Company secured a letter of credit for $0.8 million, which is recorded as noncurrent restricted cash in the consolidated balance sheets as of December 31,2024 and 2023.
In November 2022, the Company entered into an 8.25-year sublease for office, research and laboratory space in Emeryville, California, with a lease commencement date in January 2023. In conjunction with signing the lease, the Company secured a letter of credit for $2.0 million, which is recorded as noncurrent restricted cash in the consolidated balance sheets as of December 31,2024 and 2023.
The Company has a lease agreement for vivarium space for which the Company has recorded a right of use asset and liability. These arrangements are not significant in comparison to the Company’s total operating lease assets and liabilities. In addition, the Company has identified certain short-term leases which are not recorded on the Company’s balance sheet in accordance with the practical expedient elected.
The following table summarizes operating lease costs for the years ended December 31,2024 and 2023 (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Operating lease cost | $9,869 | $9,582 |
| Variable lease cost | 3,092 | 2,835 |
| Total lease cost | $12,961 | $12,417 |
Supplemental information related to the Company’s operating leases is as follows (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash paid for amounts included in the measurement of lease liabilities | $8,627 | $6,561 |
| Weighted average remaining lease term (in years) | 6.1 | 7.1 |
| Weighted-average discount rate | 11.3% | 11.3% |
The following table summarizes future minimum lease payments as of December 31,2024 (in thousands):
| Amount | |
|---|---|
| 2025 | $10,372 |
| 2026 | 9,710 |
| 2027 | 9,995 |
| 2028 | 10,328 |
| 2029 | 10,672 |
| Thereafter | 12,283 |
| Total future lease payments | 63,360 |
| Less imputed interest | (17,582) |
| Total lease liability balance | 45,778 |
| Less: current operating lease liabilities | (5,592) |
| Non-current operating lease liabilities | $40,186 |
Legal contingencies
On September 26, 2024, a class action complaint was filed in the U.S. District Court for the Northern District of California against the Company and certain of the Company’s officers and certain of its current and former directors, captioned Vreeland v. Metagenomi Inc. et al., No. 5:24-cv-06765 (the “Securities Action”). The Securities Action alleges violations of Section 11 of the Securities Act against all defendants and control person violations of Section 15 against the individuals. The Securities Action alleges that the defendants made misleading statements and omitted to disclose material information concerning the Company’s collaboration with Moderna in the Company’s registration statement and final prospectus materials filed in January 2024 and February 2024. The Securities Action seeks, among other things, compensatory damages as well as costs and expenses, including attorneys’ fees and expert fees. On February 10, 2025, the court appointed Mingxi Bi as lead plaintiff. The lead plaintiff’s amended complaint is due on April 4, 2025 under the current case schedule. The Company is currently unable to predict the outcome of this lawsuit and therefore cannot determine the likelihood of loss, if any, nor estimate a range of possible loss. The Company intends to defend vigorously against this litigation.
From time to time, the Company may become involved in legal proceedings arising from the ordinary course of business. The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount. Other than the Securities Action, the Company is currently not aware of any legal matters that could have a material adverse effect on the Company’s financial position, results of operations or cash flows.
Guarantees and indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. Its exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at a request in such capacity. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of December 31, 2024 and 2023, the Company did not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Redeemable Convertible Preferred Stock
On December 20, 2022, the Company entered into a Series B-1 redeemable convertible preferred unit purchase agreement to sell up to 7,108,480 shares of Series B-1 redeemable convertible preferred units (“Series B-1”) at the purchase price of $14.07. In December 2022, the Company sold and issued 6,773,726 Series B-1 shares for gross cash proceeds of $95.3 million in the initial closing and incurred $0.4 million issuance costs. In January 2023, the Company sold an additional 334,751 Series B-1 shares and received gross cash proceeds of $4.7 million and incurred $0.1 million in issuance costs.
The redeemable convertible preferred stock as of December 31, 2023, consisted of the following (in thousands, except share data):
| SharesAuthorized · SharesIssued and Outstanding · Original Issue Price · AggregateLiquidation Preference · Net Carrying Value | |||||||
|---|---|---|---|---|---|---|---|
| Series A-1 | 7,501,002 | 7,501,002 | $3.23 | $24,247 | $24,067 | ||
| Series A-2 | 774,473 | 774,473 | 0.65 | 500 | 581 | ||
| Series A-3 | 1,513,860 | 1,513,860 | 1.17 | 1,773 | 1,892 | ||
| Series A-4 | 8,280,360 | 8,280,360 | 4.85 | 40,149 | 40,007 | ||
| Series A-5 | 1,580,937 | 1,580,937 | 6.33 | 10,000 | 9,948 | ||
| Series B | 15,054,263 | 15,054,263 | 11.65 | 175,375 | 174,678 | ||
| Series B-1 | 7,108,480 | 7,108,480 | 14.07 | 100,000 | 99,585 | ||
| 41,813,375 | 41,813,375 | $352,044 | $350,758 | ||||
On January 24, 2024, in connection with the Reorganization, all outstanding redeemable convertible preferred units were converted into an equal number of shares of redeemable convertible preferred stock. Immediately prior to the closing of the IPO, all of the then-outstanding shares of redeemable convertible preferred stock converted into 23,935,594 shares of common stock.
Common Stock
The amended and restated certificate of incorporation authorizes the Company to issue 500,000,000 shares of common stock. Each share of common stock is entitled to cast one vote. The holders of common stock are also entitled to receive distributions whenever funds are legally available and when declared by the Company’s Board of Directors. No distributions have been declared from inception to date.
Stock-Based Compensation
2019 Equity Incentive Plan
Prior to the Reorganization, the Company granted profits interests under the 2019 Equity Incentive Plan, adopted on March 13, 2019 (the “2019 Plan”). The Company granted profits interests with a threshold amount established by the Board of Managers on the date of issu ance. The 2019 Plan allowed for grants of profits interests to the Company’s officers, employees, directors and consultants. Profits interests generally vested monthly over four years, with or without one-year cliff vesting in the first year.
The LLC Agreement provided each profits interest with a distribution threshold amount, which is determined on the date of issuance and represents the amount that would be distributed if, immediately after issuance, the Company sold all of its assets at fair market value and distributed the net proceeds in liquidation. A profits interest does not participate in Company distributions until an amount equal to its distribution threshold amount has been distributed to other members of the Company with units that either have a lower threshold amount or no threshold amount. The Company’s LLC Agreement was amended on July 31, 2023 to provide for “catch-up” distributions for profits interests once the applicable catch-up threshold amount for such profits interests was met (the “Amendment to the LLC Agreement”).
In accordance with the Amendment to the LLC Agreement, once the applicable distribution threshold amount has been met for a particular profits interest, such profits interest will participate in Company distributions on a pro rata basis until the catch-up threshold amount has been met. Once the catch-up threshold amount has been met, subsequent “catch-up” distributions will be made solely to holders of profits interests until such holders have received an amount equal to the amount such holders would have received had the distribution threshold not existed. Once the profits interest holders have received distributions in an amount equal to what they would have received had the distribution threshold not existed, all subsequent distributions are made on a pro rata basis with common unitholders. As a result of the Amendment to the LLC Agreement, the Board approved an $11.84 catch-up threshold amount, which was based on the estimated fair value of the Company’s common unit as of July 31, 2023.
As part of the catch-up and Amendment to the LLC Agreement, the Company modified the terms and conditions of the profits interest, which resulted in a change in the fair value of the awards. The change was treated as a modification under ASC 718, Stock Compensation, in which the fair value of the profits interests was remeasured at the modification date and compared to the fair value of the modified award immediately prior to the modification, with the difference resulting in incremental compensation expense. The Company estimated total modification expense of $10.3 million to be recognized over the remaining term.
As part of the Reorganization,282,660 profits interest units were canceled without a concurrent grant of a replacement award and were accounted for as a repurchase for no consideration and accordingly previously unrecognized compensation of$3.0 million was recognized at the cancelation date. Immediately after the Reorganization, all of the outstanding 9,142,176 profits interest units were exchanged for 3,884,870 shares of common stock, of which 1,036,833 were subject to certain vesting conditions. The table below presents a summary of profits interests units activity:
| ProfitsInterests | Weighted-Average Threshold Amount | AggregateIntrinsic Value(thousands) | |
|---|---|---|---|
| Outstanding as of December 31, 2023 | 9,488,776 | $2.63 | $111,022 |
| Forfeited and expired | (63,940) | 1.17 | |
| Canceled in connection with the Reorganization | (282,660) | 11.84 | |
| Exchanged for vested and unvested common stock in connection with the Reorganization | (9,142,176) | 2.36 | |
| Outstanding as of December 31, 2024 | — | $— | $— |
The aggregate intrinsic value of the profits interests as of December 31, 2023 is calculated as the positive difference between the threshold amount and the fair value of the Company’s common unit as of December 31, 2023. The Company did not issue profits interests during the year ended December 31, 2024. During the year ended December 31, 2023, the Company granted 2,267,813 profits interests with a weighted average grant date fair value of $6.73.
The following table presents a summary of the unvested common stock activity:
| Unvested Common Stock | Number of Shares | Weighted-AverageGrant DateFair Value(1) |
|---|---|---|
| Outstanding as of December 31, 2023 | — | $— |
| Exchange of profits interests units for unvested common stock | 1,036,833 | 18.80 |
| Vested | (499,148) | 13.93 |
| Forfeited | (81,250) | 16.44 |
| Outstanding as of December 31, 2024 | 456,435 | $24.54 |
(1) Weighted-average grant date fair value includes amount related to the modification as a result of the catch-up and Amendment to the LLC Agreement
The total fair value of common stock that vested during the year ended December 31, 2024 was$2.9 million. The aggregate intrinsic value of restricted stock awards outstanding on December 31, 2024 was$1.6 million.
2024 Stock Option and Incentive Plan
In January 2024, the board of directors adopted and the stockholders approved the 2024 Stock Option and Incentive Plan (“2024 Plan”), which became effective immediately prior to the closing of the IPO. The 2024 Plan allows the Company to make equity-based and cash-based incentive awards to its officers, employees, directors, and consultants. The 2024 Plan provides for the grant of incentive stock options, non-qualified stock options, restricted stock units, restricted stock awards, and other stock-based awards. Awards granted under the 2024 Plan expire no later than ten years from the date of grant. For stock options, the option price shall not be less than 100% of the estimated fair value on the date of grant. Stock options and restricted stock units typically vest over afour-year time period but may be granted with different vesting terms.
The Company initially reserved 6,690,000 shares of common stock for future issuance under the 2024 Plan. The number of shares of common stock reserved and available for issuance under the 2024 Plan will automatically increase on each January 1, commencing on January 1, 2025 and through 2034, by five percent of the number of shares of the Company’s common stock issued and outstanding on the immediately preceding December 31, or such lesser number of shares as determined by the Company’s compensation committee.
On January 1, 2025, the common stock available for issuance under the 2024 Plan automatically increased by 1,870,923 shares. As of December 31, 2024, there were 2,762,912 shares available for future issuance under the 2024 Plan.
Stock Option Activity
The following table presents a summary of the stock option activity:
| Stock Options | Number of Shares | Weighted-Average ExercisePrice | Weighted-Average Remaining Contractual Term (years) | AggregateIntrinsic Value (thousands) |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | — | $— | — | $— |
| Granted | 4,054,918 | 9.73 | ||
| Forfeited/Expired | (618,488) | 10.82 | ||
| Outstanding as of December 31, 2024 | 3,436,430 | $9.54 | 9.32 | $715 |
| Exercisable as of December 31, 2024 | 162,349 | $10.67 | 9.17 | $— |
The weighted-average grant date fair value of stock options granted during the year ended December 31, 2024 was$6.94. There wereno stock option exercises during the year ended December 31,2024.
Restricted Stock Unit Activity
The following table presents a summary of the restricted stock unit activity:
| Restricted Stock Units | Number ofShares | Weighted-AverageGrant DateFair Value |
|---|---|---|
| Outstanding as of December 31, 2023 | — | $— |
| Granted | 589,324 | 9.50 |
| Vested | (24,801) | 10.82 |
| Forfeited | (98,666) | 10.08 |
| Outstanding as of December 31, 2024 | 465,857 | $9.30 |
The total fair value of restricted stock units that vested during the year ended December 31, 2024 was$0.1 million. The aggregate intrinsic value of restricted stock units outstanding on December 31, 2024 was$1.7 million.
2024 Employee Stock Purchase Plan
In January 2024, the board of directors adopted and the stockholders approved the 2024 Employee Stock Purchase Plan (“ESPP”), which become effective upon the date immediately preceding the date on which the Company’s registration statement was declared effective by the SEC. Under the ESPP, employees, subject to certain restrictions, may purchase shares of common stock at 85% of the fair market value at either the first business day or the last business day of the offering period, whichever is lower. Purchases are limited to the lesser of 15% of each employee’s eligible annual compensation or $25,000.
The Company initially reserved 375,000 shares of common stock for future issuance under the ESPP. The number of shares of common stock reserved and available for issuance under the ESPP will automatically increase on each January 1, commencing on January 1, 2025 and through 2034, by the least of (i)750,000 shares of common stock; (ii) one percent of the number of shares of the Company’s common stock issued and outstanding on the immediately preceding December 31, or (iii) such lesser number of shares as determined by the Company’s compensation committee. On January 1,2025, the common stock available for issuance under the ESPP automatically increased by 374,184 shares. As of December 31, 2024, there were 375,000 shares available for issuance under the ESPP. As of December 31, 2024, the Company has issuedno shares under the ESPP as the first purchase has not yet occurred.
Compensation Expense
The estimated grant date fair value of the Company’s stock options and profits interests calculated using the Black-Scholes model (from January 1 to July 30, 2023) and the option-pricing model within the PWERM model (from July 31 to December 31, 2023) was based on the following assumptions:
| From July 31 to | From January 1 to | |
|---|---|---|
| December 31, 2023 | July 30, 2023 | |
| Expected volatility | 85.00% | 78.57% — 86.33% |
| Risk-free interest rate | 5.00% | 3.50% — 4.47% |
| Expected term (in years) | 1.75 | 2.00 — 4.12 |
| Expected dividend yield | — | — |
| Threshold range | $11.84 | $5.75 — $7.40 |
The estimated grant date fair value of the Company’s stock options using the Black-Scholes option-pricing model was based on the following assumptions during the year ended December 31, 2024. There were no stock option grants during the year ended December 31, 2023.
| Year Ended December 31, | |
|---|---|
| Expected volatility | 79.58% — 80.99% |
| Risk-free interest rate | 3.63% — 4.72% |
| Expected term (in years) | 5.31 — 6.08 |
| Expected dividend yield | — |
The following table presents the classification of stock-based compensation expense for the periods presented (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development expenses | $8,891 | $3,367 |
| General and administrative expenses | 7,313 | 3,555 |
| Total | $16,204 | $6,922 |
Stock-based compensation expense related to the following awards for the periods presented (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Profits Interests | $635 | $6,922 |
| Restricted Stock Awards | 9,555 | — |
| Stock Options | 5,117 | — |
| Restricted Stock Units | 884 | — |
| Employee Stock Purchase Plan | 13 | — |
| Total | $16,204 | $6,922 |
As of December 31, 2024, there was$11.5 million of unrecognized compensation expense (including modification expense related to the catch-up) related to restricted stock awards that is expected to be recognized over a weighted-average period of 1.9 years,$18.4 million of unrecognized compensation expense related to stock options that is expected to be recognized over a weighted-average period of 3.1 years and$3.7 million of unrecognized compensation expense related to restricted stock units that is expected to be recognized over a weighted-average period of 3.3 years.
Segment Information
The Company operates and manages its business asone operating and reportable segment, which is the business of developing curative therapeutics for patients using the Company’s proprietary, comprehensive metagenomics-derived genome editing toolbox. All of the Company’s long-lived assets are located in the U.S. All revenue presented relate to contracts with customers located in the U.S. Thechief executive officer, who is the chief operating decision maker(CODM), reviews financial information on a consolidated basis for purposes of evaluating financial performance, making operating decisions, allocating resources and planning and forecasting for future periods. The CODM assesses performance and decides how to allocate resources based on consolidated net loss. This measure is used to monitor budget versus actual results to evaluate the performance of the segment.
The following table presents the results of operations that are provided to the Company’s CODM for the periods presented (in thousands).
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Collaboration revenue: | ||
| Ionis | $30,439 | $21,915 |
| Moderna | 18,742 | 18,119 |
| Affini-T | 3,114 | 4,722 |
| Total collaboration revenue | 52,295 | 44,756 |
| Operating expenses: | ||
| Employee-related expenses | 47,566 | 44,133 |
| Stock-based compensation expense | 16,204 | 6,922 |
| Research and development supplies and services | 33,237 | 30,153 |
| Facilities and overhead costs | 31,572 | 27,787 |
| Professional services and consulting | 12,617 | 14,253 |
| Total operating expenses | 141,196 | 123,248 |
| Operating income | (88,901) | (78,492) |
| Other income (expense): | ||
| Interest and other | 14,515 | 15,394 |
| Change in fair value of long-term investments | (9,185) | 2,870 |
| Benefit (provision) for income taxes | 5,513 | (8,027) |
| Net loss | $(78,058) | $(68,255) |
The Company is a corporation for tax purposes and is subject to income taxes which have been included in the consolidated financial statements. All pre-tax losses have been incurred in the U.S.
Loss before benefit (provision) for income taxes is as follows for the periods presented (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Domestic | $(83,571) | $(60,228) |
| Total | $(83,571) | $(60,228) |
Income tax expense (benefit) consisted of the following for the periods presented (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Current: | ||
| Federal | $(5,513) | $8,027 |
| State | — | — |
| Total current tax expense (benefit) | (5,513) | 8,027 |
| Deferred: | ||
| Federal | — | — |
| State | — | — |
| Total deferred tax expense | — | — |
| Total tax expense (benefit) | $(5,513) | $8,027 |
The Company has generated a tax loss for the year ended December 31, 2024. The Company intends to claim research and development credits in the current year and the credit will be carried back to the prior year. The current tax liability for years ended December 31, 2023 was primarily the result of upfront payments received under collaboration agreements and the capitalization of research and development expenses under Internal revenue code Section 174 (“Section 174”).
A reconciliation of the federal statutory tax rate and the Company’s effective tax rate is as follows:
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Statutory rate | 21.0% | 21.0% |
| Nontaxable LLC losses | 0.0% | 0.1% |
| State tax rate | 0.0% | 0.0% |
| Share-based compensation | (3.2)% | 0.0% |
| Permanent and other adjustments | (0.9)% | (2.3)% |
| Change in valuation allowance | (16.2)% | (39.2)% |
| Research credits | 5.9% | 7.1% |
| Total | 6.6% | (13.3)% |
Significant components of the deferred tax assets for federal and state income taxes are as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred Tax Assets: | ||
| Net operating loss carry forwards | $17,852 | $1,226 |
| Research credits | 3,578 | 2,985 |
| Reserves and accruals | 3,923 | 1,472 |
| Lease liability | 12,810 | 13,496 |
| Deferred revenue | 9,341 | 21,257 |
| Capitalized research and development expenses | 33,606 | 23,532 |
| Total deferred tax assets | 81,110 | 63,968 |
| Deferred Tax Liabilities: | ||
| Property and equipment | (3,387) | (3,976) |
| Right-of-use asset | (11,170) | (12,204) |
| Total gross deferred tax liabilities | (14,557) | (16,180) |
| Less: Valuation allowance | (66,553) | (47,788) |
| Net deferred tax assets | $— | $— |
A valuation allowance is required to be established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. The Company believes that, based on a number of factors such as the history of operating losses, it is more likely than not that the deferred tax assets will not be fully realized, such that a full valuation allowance has been recorded. The valuation allowance increased by$18.8 million for the year ended December 31, 2024 primarily due to the increase in net operating loss carryforwards and capitalization of research and development expenses under Section 174. The valuation allowance increased by$28.9 million for the year ended December 31, 2023 primarily due to the increase in deferred revenue and capitalization of research and development expenses under Section 174.
As of December 31, 2024, the Company had$45.6 million and$118.3 million of net operating loss carryforwards for federal and state income tax purposes, respectively. Federal net operating loss carryforwards do not expire. State net operating loss carryforwards begin expiring in 2037. As of December 31, 2024, the Company hadzero and$4.5 million of research credit carryforwards for federal and state income tax purposes, respectively. State research credit carryforwards do not expire and can be carried forward indefinitely.
Utilization of some of the federal and state net operating losses and credit carryforwards may be subject to annual limitations due to the change in ownership provisions of the Internal Revenue Code of 1986 (“Internal Revenue Code”) and similar state provisions. The annual limitation may result in the expiration of net operating losses and credits before utilization.
The Company uses the “more likely than not” criterion for recognizing the income tax benefit of uncertain income tax positions and establishing measurement criteria for income tax benefits. Although it is reasonably possible that certain unrecognized tax benefits may increase or decrease within the next twelve months due to tax examination changes, settlement activities, expirations of statute of limitations, or the impact on recognition and measurement considerations related to the results of published tax cases or other similar activities, the Company does not anticipate significant changes to unrecognized tax benefits over the next 12 months. The Company recognizes interest related to income tax matters as a component of income tax expense. As of December 31, 2024, the amount of accrued interest related to uncertain tax positions was$0.3 million. During the years ended December 31, 2024 and 2023, no penalties were recognized relating to unrecognized tax benefits. In the event the Company should need to recognize penalties related to unrecognized income tax liabilities, this amount will be recorded as an accrued liability and an increase to income tax expense.
Changes in the balance of gross unrecognized tax benefits, which excludes interest and penalties, are as follows (in thousands):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Beginning balance | $5,943 | $1,755 |
| Gross increases—tax position in current period | 2,234 | 3,731 |
| Gross increases—tax position in prior periods | 121 | 1,576 |
| Reductions for tax positions of prior years | (751) | (1,119) |
| Ending balance | $7,547 | $5,943 |
The Company files tax returns in the U.S. and California. The Company is not currently under examination in any of these jurisdictions and all its tax years remain effectively open to examination due to net operating losses from inception. As of December 31, 2024, the balance of unrecognized tax benefits was$7.5 million of which$6.4 million, if recognized, would affect the effective tax rate.
Net Loss Per Share
Basic and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands except share and per share amounts):
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator: | ||
| Net loss attributable to common stockholders | $(78,058) | $(68,255) |
| Denominator: | ||
| Weighted-average common shares outstanding | 33,563,281 | 3,404,585 |
| Less: Weighted-average unvested shares of common stock | (535,392) | — |
| Weighted-average common shares outstanding—basic and diluted | 33,027,889 | 3,404,585 |
| Net loss per share attributable to common stockholders—basic and diluted | $(2.36) | $(20.05) |
The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share, as their effect would have been anti-dilutive:
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Common stock issuable upon conversion of redeemable convertible preferred stock | — | 23,935,594 |
| Common stock issuable upon settlement of profits interests | — | 3,916,677 |
| Restricted stock subject to future vesting | 456,435 | — |
| Options to purchase common stock | 3,436,430 | — |
| Restricted stock units | 465,857 | — |
| Total | 4,358,722 | 27,852,271 |
Employee Retirement Plan
The Company has a defined contribution plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”), covering its employees. Employees may contribute a percentage of their annual compensation to this plan, subject to the maximum allowable amount set by the Internal Revenue Service. The 401(k) Plan provides that the Company matches each participant’s contribution at 100% up to the first 5% of the employee’s eligible compensation. The Company’s contributions to the 401(k) Plan were$1.7 million and$1.4 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.