PRECIGEN, INC.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
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Sep 30, 2025 · Filed Nov 13, 2025
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Notes to the Condensed Consolidated Financial Statements
(Amounts in thousands, except share and per share data)
- Organization
Precigen, Inc. ("Precigen"), a Virginia corporation, is a biopharmaceutical company advancing the next generation of gene and cell therapies with the overall goal of improving outcomes for patients with significant unmet medical needs. Precigen is leveraging its proprietary technology platforms to develop product candidates designed to target urgent and intractable diseases in its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Precigen’s primary operations are located in the state of Maryland. In August 2025, Precigen announced that Papzimeos™ (Zopapogene Imadenovec), an adenoverse gene therapy, had received full approval by the U.S. Food and Drug Administration ("FDA") for the treatment of adults with recurrent respiratory Papillomatosis ("RRP"), and a confirmatory clinical trial is not required. Papzimeos is the first immunotherapy approved for the treatment of RRP. Papzimeos has also received Orphan Drug designation from the European Commission. The FDA approval of Papzimeos transitions Precigen from a development-stage to a commercial-stage company.
Precigen also hasone wholly-owned operating subsidiary, Exemplar Genetics, LLC ("Exemplar"). Exemplar is committed to enabling the study of life-threatening human diseases through the development of MiniSwine Yucatan miniature pig research models and services. Exemplar's primary operations are located in the State of Iowa.
Precigen's other historical operating subsidiary, Precigen ActoBio, Inc. ("ActoBio") ceased operations during 2024. ActoBio utilized a proprietary class of microbe-based biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics and was located in Ghent, Belgium.
As part of a continuing effort to strategically prioritize the application of resources to particular development efforts, in 2024 the Company initiated a shutdown of ActoBio's operations. This included the commencement of terminating leases and employees, and the disposition of certain of its assets and obligations with a focus on the preservation of ActoBio's intellectual property, which was completed during the third quarter of 2024.
In addition to the actions taken at ActoBio, in August 2024 the Company also began undertaking a strategic prioritization of its clinical portfolio and streamlining of its resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of Papzimeos. These strategic changes were designed to reduce required resources for non-priority programs and enable the Company to focus on pre-commercialization efforts for PRGN-2012 (now Papzimeos), including supporting the submission of a rolling BLA under an accelerated approval pathway which was filed in the fourth quarter of 2024 and manufacturing commercial product. Additionally, the Company has continued commercial readiness efforts for the launch of Papzimeos.
Precigen and its consolidated subsidiaries are hereinafter referred to as the "Company." As discussed in Note 15, the Company now operates asone segment.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP"). Certain information and footnote disclosures normally included in the Company's annual financial statements have been condensed or omitted. These interim condensed consolidated financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for fair statement of the Company's financial position as of September 30, 2025 and results of operations and cash flows for the interim periods ended September 30, 2025 and 2024. The year-end condensed consolidated balance sheet data was derived from the Company's audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2025, or for any other future annual or interim period. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and related notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024.
The accompanying condensed consolidated financial statements reflect the operations of Precigen and its majority-owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Liquidity
As of September 30, 2025, the Company had $123,643 in cash, cash equivalents and investments, which includes proceeds from the non-dilutive financing agreement entered into in the third quarter of 2025 (see Note 9).
Management believes that existing liquid assets as of September 30, 2025 will allow the Company to continue its operations for at least a year from the issuance date of these condensed consolidated financial statements. During the nine months ended September 30, 2025, the Company used $64,371 of cash in its operations, and as of September 30, 2025, had an accumulated deficit of $2,317,845.
As the Company continues to incur losses, its transition to profitability will depend on the successful commercialization of product candidates and on the achievement of sufficient revenues to support the Company's cost structure. In addition, the Company may decide, or be required, to raise additional capital. This additional capital could be raised through a combination of non-dilutive financings (including debt financings, collaborations, strategic alliances, monetization of core and non-core assets, marketing, distribution or licensing arrangements, and/or dilutive financings including equity and/or debt financings which may include an equity component). Also, any collaborations, strategic alliances, monetization of assets or marketing, distribution or licensing arrangement may require the Company to give up some or all of its rights to a product or technology, which in some cases may be at less than the full potential value of such rights.
These interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern and do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
Risks and Uncertainties
The Company is subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and development of therapeutic product candidates. Principal among these risks are dependence on key individuals and intellectual property, competition from other products and companies, market acceptance and third-party payor coverage for our products, development of sales channels; and the technical risks associated with the successful research, development and clinical and commercial manufacturing of its therapeutic product candidates.
Research and Development
The Company considers that regulatory requirements inherent in the research and development of new products preclude it from capitalizing such costs. Research and development expenses include salaries and related costs of research and development personnel, including stock-based compensation expense, costs to acquire or reacquire technology rights, contract research organizations and consultants, facilities, materials and supplies associated with research and development projects as well as various laboratory studies. Manufacturing costs related to products that do not have regulatory approval are also included as research and development costs. Lastly, costs incurred in conjunction with collaboration and licensing arrangements are included in research and development. Indirect research and development costs include depreciation, amortization, and other indirect overhead expenses. The Company has research and development arrangements with third parties that include upfront and milestone payments. As of September 30, 2025 and December 31, 2024, the Company had research and development commitments with third parties that had not yet been incurred totaling $6,449 and $5,885, respectively. The commitments are generally cancellable by the Company by providing written notice at least sixty days before the desire termination date.
Cash and Cash Equivalents
All highly liquid investments with an original maturity ofthree months or less at the date of purchase are considered to be cash equivalents. Cash balances at a limited number of banks may periodically exceed insurable amounts. The Company believes that it mitigates its risk by investing in or through major financial institutions. Recoverability of investments is dependent upon the performance of the issuer.
Investments
As of September 30, 2025 and December 31, 2024, short-term and long-term investments include corporate bonds, United States government debt and certificates of deposit. The Company determines the appropriate classification as short-term or long-term at the time of purchase based on original maturities and management's reasonable expectation of sales and redemption. The Company reevaluates such classification at each balance sheet date.
Fair Value of Financial Instruments
Fair value is 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. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset and liability. As a basis for considering such assumptions, the Company uses a three-tier fair value hierarchy that prioritizes the inputs used in its fair value measurements. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows:
| Level 1: | Quoted prices in active markets for identical assets and liabilities; |
|---|---|
| Level 2: | Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly; and |
| Level 3: | Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available. |
Inventory
The Company began capitalizing inventory in the third quarter of 2025 once regulatory approval of Papzimeos was received. Prior to this point, all related costs were expensed as incurred and classified as research and development expenses. Inventories include the cost for materials, third-party contract manufacturing and packaging services, and overhead associated with manufacturing. Inventory is stated at the lower of cost or net realizable value, and is determined using the first-in, first-out method.
The Company evaluates inventory recoverability at each reporting period and adjusts net realizable value for excess, slow-moving, or obsolete inventory. If the net realizable value is lower than cost, the inventory is written down accordingly, and the resulting impairment charge is recognized as a component of cost of goods sold.
Inventory used for clinical development purposes is expensed to research and development expense when consumed. Shipping and handling costs for product shipments to customers are recorded as incurred in cost of products sold.
Net Loss per Share
Basic net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted average shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, using the treasury-stock method. For purposes of the diluted net loss per share calculation, shares to be issued pursuant to stock options, restricted stock units ("RSUs"), performance stock units ("PSUs") and warrants (see Note 11) are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore, basic and diluted net loss per share were the same for all periods presented.
The following potentially dilutive securities as of September 30, 2025 and 2024 have been excluded from the above computations of diluted weighted average shares outstanding for the three and nine months then ended as they would have been anti-dilutive:
| September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Options | 28,252,048 | 26,857,820 |
| Restricted stock units | 2,342,426 | 3,804,057 |
| Performance stock units | 1,030,000 | — |
| Warrants | 52,666,669 | — |
| Total | 84,291,143 | 30,661,877 |
Long-term debt
The Company's term loans are initially recognized at fair value, net of any directly attributable transaction costs. Subsequent to initial recognition, debt is measured at amortized cost using the effective interest method, unless designated at fair value through profit or loss. Interest expense is recognized in the Condensed Consolidated Statements of Operations using the effective interest rate, which allocates interest over the relevant period.
The Company evaluates the classification of debt instruments based on their contractual terms and features, including any embedded derivatives or conversion options. As of September 30, 2025, the Company’s outstanding long-term debt (Note 9) includes afive-year term loan entered into on September 3, 2025, which is accounted for at amortized cost. The loan does not contain any equity conversion features and is not designated at fair value. As of September 30, 2025, the entire outstanding balance of the Company’s debt was classified as long-term, as no principal payments are due within twelve months of the reporting date.
The debt agreement includes certain financial and non-financial covenants. The Company evaluates compliance with these covenants on a quarterly basis and, as of September 30, 2025, was in compliance with all applicable covenants.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification ("ASC") 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding. For warrants that are liability-classified, changes in fair value are included in Change in fair value of warrant liabilities in the Condensed Consolidated Statements of Operations. If facts and circumstances lead the warrant liability to be reclassified to shareholders' equity, warrant liabilities are remeasured as of the event date and reclassified from liabilities to shareholders' equity. In the third quarter of 2025, the Warrant liabilities were reclassified to shareholders' equity and will no longer be adjusted to fair value at each reporting period.
Mezzanine Equity
Where ordinary or preferred shares are determined to be conditionally redeemable upon the occurrence of certain events that are not solely within the control of the Company, and upon such event, the shares would become redeemable at the option of the holder, or when the Company currently does not have a sufficient number of authorized and unissued shares available to share settle the instrument, they are classified as "mezzanine equity" (temporary equity). The purpose of this classification is to convey that such a security may not be permanently part of equity and could result in a demand for cash, securities or other assets of the entity in the future.
The Company evaluates whether the contingent redemption provisions are probable of becoming redeemable to determine whether the carrying value of the redeemable convertible preferred units is required to be remeasured to their respective redemption values. All instruments that are classified as mezzanine equity are evaluated for embedded derivative features by evaluating each feature against the nature of the host instrument (e.g., more equity-like or debt-like). Features identified as freestanding instruments or bifurcated embedded derivatives that are material are recognized separately as a derivative asset or liability in the consolidated financial statements. In the event convertible preferred shares utilize a conversion term that results in the delivery of a variable number of shares of common stock upon conversion as compared to the original terms of the agreement, such conversion will be treated as a redemption. If classification of an equity instrument as temporary equity is no longer required, the existing carrying amount of the equity instrument should be reclassified to permanent equity at the date of the event that caused the reclassification.
In the third quarter of 2025, all of the holders of preferred stock converted their shares to common stock (see Note 11).
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 revenues and expenses during the reporting periods. Actual results could differ from those estimates.
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, in order to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses in commonly presented expense captions. The amendments in ASU 2024-03 require disclosure, in the notes to the financial statements, of specified information about certain costs and expenses in interim and year-end reporting periods. The amendments in this ASU apply to all public business entities and are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. The Company is currently assessing the impact of the new guidance on its financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures to enhance the transparency and decision usefulness of income tax disclosures. The guidance will require improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. The amendments in this ASU apply to all public business entities and are effective for annual reporting periods beginning after December 15, 2024. The Company is currently assessing the impact of the new guidance on its financial statement disclosures.
There are no other new accounting standards which have not yet been adopted that are expected to have a significant impact on our financial statements and related disclosures.
- Collaboration and Licensing Revenue, and Deferred Revenue
The Company's collaborations and licensing agreements may provide for multiple promises to be satisfied by the Company and typically include a license to the Company's technology platforms, participation in collaboration committees, and performance of certain research and development services. Based on the nature of the promises in the Company's collaboration and licensing agreements, the Company typically combines most of its promises into a single performance obligation because the promises are highly interrelated and not individually distinct. Options to acquire additional services are considered to determine if they constitute material rights. At contract inception, the transaction price is typically the upfront payment received and is allocated to the performance obligations. The Company has determined the transaction price should be recognized as revenue based on its measure of progress under the agreement primarily based on inputs necessary to fulfill the performance obligation.
The Company determines whether collaborations and licensing agreements are individually significant for disclosure based on a number of factors, including total revenue recorded by the Company pursuant to collaboration and licensing agreements, collaborators or licensees with equity method investments, or other qualitative factors. Collaboration and licensing revenues generated from consolidated subsidiaries are eliminated in consolidation.
Agilis Biotherapeutics Collaboration
In October 2013, the Company entered into an exclusive channel collaboration agreement ("ECC") with Agilis Biotherapeutics, Inc. (Agilis), a then privately held synthetic biology-based company focused on rare genetic diseases, which was subsequently acquired by PTC Therapeutics, Inc. ("PTC") in August 2018. Upon execution of the ECC, the Company received a technology access fee of $2,500 as upfront consideration. Additionally, the Company historically received reimbursement payments for research and development services provided pursuant to the agreement during the ECC. Although services under the agreement had paused in 2016, the Company withheld recognizing a portion of the upfront payment as the ECC was perpetual and Agilis had the right and ability to resume the program at any time. In September 2025, the Company and PTC mutually agreed to terminate the ECC agreement and accordingly, the Company recognized the remaining balance of deferred revenue associated with the agreement as collaboration and licensing revenue totaling $1,818.
There was no other collaboration and licensing revenue recognized during both the three and nine months ended September 30, 2025 and 2024.
Deferred Revenue
Deferred revenue historically consisted primarily of upfront and milestone consideration received for the Company's historical collaboration and licensing agreements. Revenue is recognized as services are performed. The arrangements classified as long-term are not active while the respective counterparties evaluate the status of the project and its desired future development activities since the Company cannot reasonably estimate the amount of services, if any, to be performed over the next year.
Deferred revenue consisted of the following:
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Collaboration and licensing agreements- Long-term liability | $— | $1,818 |
| Prepaid product and service revenues - Long-term liability | 95 | 116 |
| Prepaid product and service revenues - Short-term liability | 480 | 589 |
| Total | $575 | $2,523 |
- Investments
The Company's investments are classified as available-for-sale. The following table summarizes the amortized cost, gross unrealized gains and losses, and fair value of available-for-sale investments as of September 30, 2025:
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| U.S. government debt securities | $105,963 | $34 | $(11) | $105,986 |
| Certificates of deposit | 2,773 | 1 | — | 2,774 |
| Corporate bonds | 561 | — | — | 561 |
| Total | $109,297 | $35 | $(11) | $109,321 |
The estimated fair value of available-for-sale investments classified by their contractual maturities as of September 30, 2025 was:
| Due within one year | $106,813 |
|---|---|
| After one year through two years | 2,508 |
| Total | $109,321 |
The following table summarizes the amortized cost, gross unrealized gains and losses, and fair value of available-for-sale investments as of December 31, 2024:
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| U.S. government debt securities | $67,464 | $15 | $(5) | $67,474 |
| Certificates of deposit | 848 | 3 | — | 851 |
| Corporate bonds | 69 | — | (1) | 68 |
| Total | $68,381 | $18 | $(6) | $68,393 |
The estimated fair value of available-for-sale investments classified by their contractual maturities as of December 31, 2024 was:
| Due within one year | $68,393 |
|---|---|
| After one year through two years | — |
| Total | $68,393 |
In addition, at September 30, 2025 and December 31, 2024, the Company held U.S. government debt securities valued at $9,389 and $24,169, respectively, which were included in cash and cash equivalents in the condensed consolidated balance sheets as these investments had an original maturity of less than three months when purchased.
Changes in market interest rates and bond yields cause certain investments to fall below their cost basis, resulting in unrealized losses on investments.
- Fair Value Measurements and Warrant Liabilities
The carrying amount of cash and cash equivalents, receivables, accounts payable, accrued compensation and benefits, and other accrued liabilities approximate fair value due to the short maturity of these instruments.
The following table presents the placement in the fair value hierarchy of financial assets that are measured at fair value on a recurring basis as of September 30, 2025:
| Quoted Prices in Active Markets(Level 1) | Significant Other Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | September 30,2025 | |
|---|---|---|---|---|
| Assets | ||||
| U.S. government debt securities | $— | $105,986 | $— | $105,986 |
| Certificates of deposit | — | 2,774 | — | 2,774 |
| Corporate bonds | — | 561 | — | 561 |
| Total | $— | $109,321 | $— | $109,321 |
The following table presents the placement in the fair value hierarchy of financial assets that are measured at fair value on a recurring basis as of December 31, 2024:
| Quoted Prices in Active Markets(Level 1) | Significant Other Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | December 31,2024 | |
|---|---|---|---|---|
| Assets | ||||
| U.S. government debt securities | $— | $67,474 | $— | $67,474 |
| Certificates of deposit | — | 851 | — | 851 |
| Corporate bonds | — | 68 | — | 68 |
| Total | $— | $68,393 | $— | $68,393 |
The method used to estimate the fair value of the Level 2 investments in the tables above is based on professional pricing sources for identical or comparable instruments, rather than direct observations of quoted prices in active markets.
Financial Liabilities
Term Loans
Due to the variable rate nature of the Term Loans, the Company believes that the carrying amount approximates fair value at September 30, 2025.
Warrant liabilities
The Warrant liabilities as of December 31, 2024(as defined below) are comprised of outstanding warrants to purchase 52,666,669 shares of common stock, no par value per share at an exercise price of $0.75 per share issued in a private placement in December 2024.
As of December 31, 2024, the Warrants were accounted for as liabilities as the Warrants provided the holder the right to acquire, via a paid in kind ("PIK") dividend on the Series A Preferred Stock for the firsttwo years following the issue date of the Series A Preferred Stock (see Note 11), a number of additional warrants to purchase shares of common stock equal to 50% of the amount of such PIK dividends divided by the $0.75 exercise price ("PIK Warrants"), which failed the requirement of the indexation guidance under ASC 815-40. The Warrants and PIK Warrants (together the "Warrant liabilities") were measured at fair value at inception and the fair value of the outstanding Warrants were re-measured at the end of each of the previous reporting periods and then again at date of which the Warrant liabilities were reclassified to shareholders' equity, which occurred in the third quarter of 2025.
In connection with the Series A Preferred Stock conversion in September 2025 (see Note 11 for further discussion), the preferred shareholders forfeited their rights to the PIK dividends as the conversion occurred prior to the first of the two stated PIK dividend dates. As a result, as of the conversion date and going forward the warrants met the equity scope exception to be classified in shareholders’ equity and are not subject to remeasurement, provided that the Company continues to meet the criteria for equity classification.
For the three months ended September 30, 2025, the Company recorded a non-cash expense representing the change in the fair value of the Warrant liabilities in the amount of approximately $111,502 on the accompanying condensed consolidated statements of operations, resulting in warrant liabilities of $190,060 as of September 17, 2025, when the Series A Preferred Stock was converted to common stock. The Warrant liabilities, after being remeasured, were reclassified to additional paid-in capital within shareholders' equity.
The changes in the fair value of the Warrant liabilities measured utilizing Level 3 inputs for the nine months ended September 30, 2025 were as follows:
| Warrant liabilities as of December 31, 2024 | $50,537 |
|---|---|
| Change in fair value of Warrant liabilities | 139,523 |
| Reclassification of Warrant liabilities to equity | (190,060) |
| Warrant liabilities as of September 30, 2025 | $— |
Prior to the reclassification of the Warrant liabilities to equity, the Company used various option pricing models, such as the Black-Scholes option pricing model and the Monte Carlo simulation model, to estimate the fair value of the Warrant liabilities. In using these models, the Company made certain assumptions about risk-free interest rates, dividend yields, volatility, expected term of the Warrants and other assumptions. Risk-free interest rates are derived from the yield on U.S. Treasury debt securities. Dividend yields are based on our historical dividend payments, which have been zero to date. Volatility is estimated from the historical volatility of our common stock as traded on the Nasdaq Stock Market Exchange. The expected term of the Warrants was based on the time to expiration of the Warrants from the date of measurement.
The fair value of the Warrants was estimated using a Black‑Scholes option-pricing model. The significant assumptions used in preparing the option pricing model for valuing the Warrant liabilities as of September 17, 2025 (the date the Warrant liabilities qualified for permanent equity classification), include (i) volatility of 88.5% (discounted for lack of marketability), (ii) risk free interest rate of 4.0%, (iii) strike price ($0.75), (iv) fair value of common stock ($3.82), and (v) expected life of 9 years, 3 months, 15 days. As of December 31, 2024, the significant assumptions included (i) volatility of 86.2% (discounted for lack of marketability), (ii) risk free interest rate of 4.5%, (iii) strike price ($0.75), (iv) fair value of common stock ($0.93), and (v) expected life of 10 years.
The fair value of the PIK Warrants was estimated using a Black-Scholes option pricing model within a Monte Carlo simulation model framework. As of December 31, 2024 , the significant assumptions included (i) volatility of 86% (discounted for lack of marketability), (ii) risk free interest rate range of 4.1% to 4.2%, (iii) strike price ($0.75), (iii) term to PIK Warrant payment date ofone totwo years, and (vii) expected Company's stock price range to the corresponding PIK Warrant payment date of $0.06 to $3.05.
Preferred Stock - PIK Dividends
On December 30, 2024, the Company issued in a private placement 79,000 shares of its 8.00% Series A Convertible Perpetual Preferred Stock (the "Series A Preferred Stock") and warrants to purchase an aggregate of 52,666,669 shares of its common stock (the "Warrants") at an exercise price of $0.75, for gross proceeds of $79,000. In accordance with the Articles of Amendment to the Company's amended and restated articles of incorporation, on each PIK dividend payment date, the stated value of the Series A Preferred Stock shall automatically be increased by the accumulated PIK dividend amount. The PIK dividends were determined to be discretionary and as such, they are measured at fair value as of the date they accumulate. Due to the absence of retained earnings, the adjustment to record the value of the PIK dividends was recorded as a reduction to additional paid-in capital. No PIK dividend was required to be accrued as of December 31, 2024 nor at September 30, 2025, as a result of the Series A Preferred Stock conversion that occurred in September 2025. See Note 11 for further discussion on the Series A Preferred Stock conversion and PIK dividends.
- Inventory
On August 14, 2025, the FDA approved Papzimeos (zopapogene imadenovec-drba), marking the first immunotherapy approved for the treatment of RRP, and commenced capitalization of inventory from this date.
Prior to August 14, 2025, regulatory approval and subsequent commercialization of Papzimeos and thus the possibility of future economic benefits from Papzimeos sales were not considered probable and inventory-related costs were expensed as incurred; as such, the inventory recognized on the balance sheet does not include any pre-launch inventory.
The components of inventory are as follows (consisting of costs incurred subsequent to the FDA approval of Papzimeos):
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Raw Materials | $4 | $— |
| Work in process | 3,008 | — |
| Finished Goods | 47 | — |
| Total inventory | $3,059 | $— |
- Property, Plant and Equipment, Net
Property, plant and equipment consist of the following:
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Land and land improvements | $164 | $164 |
| Buildings and building improvements | 2,629 | 2,629 |
| Furniture and fixtures | 603 | 364 |
| Equipment | 19,275 | 16,774 |
| Leasehold improvements | 11,903 | 4,478 |
| Breeding stock | 79 | 88 |
| Computer hardware and software | 2,903 | 3,186 |
| Construction and other assets in progress | 263 | 9,019 |
| 37,819 | 36,702 | |
| Less: Accumulated depreciation and amortization | (23,006) | (22,871) |
| Property, plant and equipment, net | $14,813 | $13,831 |
During the three months ended September 30, 2025, in connection with the FDA approval, approximately $10,253 was reclassified from construction in progress to machinery and equipment, and leasehold improvements related to the Company's commercial manufacturing suite.
Depreciation expense was $485 and $356 for the three months ended September 30, 2025 and 2024, respectively, and $1,107 and $1,124 for the nine months ended September 30, 2025 and 2024, respectively.
- Goodwill and Intangible Assets, Net
The changes in the carrying amount of goodwill for the nine months ended September 30, 2025 were as follows:
| Balance at December 31, 2024 | $19,139 |
|---|---|
| Impairment recorded in the second quarter of 2025 | (3,907) |
| Balances at September 30, 2025 | $15,232 |
The Company had $36,189 and $32,282 of cumulative impairment losses as of September 30, 2025 and December 31, 2024.
The Company completes its annual goodwill impairment test during the fourth quarter of each year, or more frequently if triggering events indicate a possible impairment in one or more of its reporting units. During the second quarter of 2025, the Company lowered its financial expectations related to the Exemplar reporting unit for the remainder of 2025 and into 2026 due to projected delays in the timing of planned product and services rendered to existing and new customers. These factors constituted an interim triggering event as of the end of the Company's second quarter of 2025, and the Company performed an impairment analysis with regard to its goodwill.
The revised projections were used as a key input into Exemplar's reporting unit’s annual goodwill impairment test performed as of June 30, 2025. The Company recorded an impairment charge of $3,907 in the second quarter of 2025, which represented the estimated excess of carrying value over fair value of this reporting unit. The Company estimated the fair value of its reporting unit utilizing a combination of a discounted present value cash flow model as well as a market earnings multiple approach.
Intangible assets consist of the following as of September 30, 2025:
| Gross Carrying Amount | Accumulated Amortization | Net | |
|---|---|---|---|
| Patents, developed technologies and know-how | $15,912 | $(12,412) | $3,500 |
Intangible assets consist of the following as of December 31, 2024:
| Gross Carrying Amount | Accumulated Amortization | Net | |
|---|---|---|---|
| Patents, developed technologies and know-how | $15,912 | $(11,457) | $4,455 |
Amortization expense was $318 for the three months ended September 30, 2025 and 2024, respectively, and $955 and $2,741 for the nine months ended September 30, 2025 and 2024, respectively.
- Long-Term Debt
Term Loans
On September 3, 2025, the Company entered into a Loan Agreement (the “Loan Agreement”) with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership as the lenders thereunder (the “Lenders”) and BioPharma Credit PLC as the collateral agent, each of which are investment entities managed by Pharmakon Advisors, LP. The Company received net proceeds of $92,818 after deducting underwriting discounts and offering expenses of $7,182.
The Loan Agreement provides for a 5-year senior secured term loan facility of up to $125.0 million, composed oftwo committed tranches: (i) an initial tranche in an aggregate principal amount of $100.0 million, which was funded on September 3, 2025; and (ii) a delayed draw tranche in an aggregate principal amount of $25.0 million, which is available, subject to certain conditions, until June 29, 2027 (such tranches, collectively, the “Term Loans”). The Term Loans mature on September 3, 2030 (the “Maturity Date”). Beginning on December 31, 2028, the Term Loans require eight equal quarterly principal payments of $12.5 million (adjusted for any borrowings under the second tranche, if any) until maturity, and all remaining outstanding amounts, if any, become due and payable on September 3, 2030. Interest rates for borrowings under the Loan Agreement are determined by a secured overnight financing rate ("SOFR") plus a margin. The interest rate for the Term Loans is based upon the sum of (a) the applicable margin (6.50%), and (b) the 3-month forward-looking term rate based on SOFR, subject to a floor of 3.75%. The Term Loans bear interest at Term SOFR (three-month tenor), subject to a 3.75% floor, plus 6.50%, payable quarterly. The effective interest rate of the Term Loan, including amortization of debt issuance costs was 12.5% for the three months ended September 30, 2025. No repayment of principal was made during the three months ended September 30, 2025.
The Company’s obligations under the Loan Agreement are secured by substantially all of its U.S. assets, including intellectual
property, and are guaranteed by certain of its subsidiaries, each of which has pledged substantially all of its assets to secure such guarantee.
The following table reflects the Company's long-term debt as of September 30, 2025 and December 31, 2024, respectively:
| September 30, 2025 | December 31, 2024 | |
|---|---|---|
| Outstanding principal balance | $100,000 | $— |
| Unamortized debt discount and issuance costs | (7,110) | — |
| Carrying value | $92,890 | $— |
The effective interest rate of the Term Loan, including amortization of debt issuance costs was 12.5% for the three months ended September 30, 2025. No repayment of principal was made during the three months ended September 30, 2025.
The Company incurred $7,182 of debt discount and debt issuance costs for the Term Loans, which are capitalized and deferred when incurred and subsequently amortized over the term of the Term Loans. Interest expense in relation to the Term Loans, including debt discount and debt issuance cost amortization is as follows:
| Three and nine months ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash Interest Expense | $830 | $— |
| Non-cash interest expense | 72 | — |
| Total interest expense | $902 | $— |
The Company determined that all of the embedded features identified in the Loan Agreement were either clearly and closely related to the debt host and did not require bifurcation as a derivative liability, or the fair value of the bifurcated features was immaterial to the Company’s consolidated financial statements.
The Term Loans contain customary affirmative and restrictive covenants and representations and warranties including, without limitation, (i) information delivery requirements, (ii) obligations to maintain insurance, (iii) preservation of intellectual property and regulatory approvals, and (iv) compliance with applicable laws. Additionally, there are certain restrictive covenants, including, without limitation, (i) limitations on the incurrence of additional indebtedness, (ii) limitations on the incurrence of liens, (iii) restrictions on the payment of dividends and other restricted payments, (iv) restrictions on investments, (v) restrictions on asset transfers, (vi) restrictions on mergers and similar transactions, (vii) restrictions on amendments to organizational documents and material contracts, in each case subject to specified exceptions, (viii) minimum net sales and (ix) minimum liquidity. The Loan Agreement also contains customary representations and warranties, including, without limitation, with respect to (i) organization, authority and enforceability, (ii) financial condition, (iii) compliance with laws, (iv) intellectual property and regulatory matters, and (v) the absence of a material adverse change. The Term Loans may be voluntarily prepaid in whole (but not in part) and must be prepaid upon change in control, and are subject to make-whole, prepayment premium and exit fee provisions. Proceeds of the Term Loans will be used to fund the Company’s commercial launch of Papzimeos as well as other general corporate and working capital requirements. The Term Loans include customary events of default, which may require the Company to pay an additional 3% interest on the outstanding loans under the Term Loan Facility. As of September 30, 2025, the Company was in compliance with its debt covenants under the Loan Agreement.
Line of Credit
Exemplar had a $5,000 revolving line of credit with American State Bank that matured on November 1, 2025 and was not renewed. As of September 30, 2025 and December 31, 2024, the line of credit bore interest at a stated rate of 8.00% per annum. As of September 30, 2025 and December 31, 2024, there wasno outstanding balance. Management does not expect the expiration of this facility to have a material impact on the Company’s liquidity.
Future Maturities
Future maturities of long-term debt as of September 30, 2025 are as follows:
| 2025 | $— |
| 2026 | — |
| 2027 | — |
| 2028 | 12,500 |
| 2029 | 50,000 |
| 2030 | 37,500 |
| Thereafter | — |
| $100,000 |
- Income Taxes
The Company computes its year-to-date tax expense or benefit by applying the annual effective tax rate to year-to-date pretax income or loss and adjusts for discrete items recorded in the period. The annual effective tax rate is the ratio of estimated annual income tax expense related to estimated pretax loss from continuing operations, excluding significant unusual or infrequently occurring items. As a result of the pretax losses anticipated for the full year which are not benefited, this rate has been calculated and applied to the year-to-date interim period’s ordinary income or loss on a jurisdiction by jurisdiction basis to determine the income tax expense/benefit allocated to the year-to-date period. The annual effective tax rate is revised, if necessary, at the end of each interim period based on the Company’s most current best estimate. There was$0 and$3 of income tax expense for the three and nine months ended September 30, 2025, respectively, and $12 of income tax expense and $1,706 of income tax benefit for thethree and nine months ended September 30, 2024, respectively. The effective tax rate differs from the U.S. statutory tax rate, primarily as a result of the change in valuation allowance required.
The Company's net deferred tax assets are offset by a valuation allowance due to the Company's history of net losses combined with an inability to confirm recovery of the tax benefits of the Company's tax attributes and other net deferred tax assets. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”), which includes certain tax provisions, was signed into law. The OBBBA did not have a material impact on our consolidated financial statements.
- Mezzanine Equity and Shareholders' Equity
As of September 30, 2025, under the Company’s amended and restated articles of incorporation, the Company is authorized to issue 700,000,000 shares of common stock and 25,000,000 shares of preferred stock.
Amendment to the Articles of Incorporation - Series A Preferred Stock
On December 27, 2024, Precigen filed articles of amendment (the “Articles of Amendment”) to its amended and restated articles of incorporation with the State Corporation Commission of the Commonwealth of Virginia ("SCC") , including a form of certificate for the Series A Preferred Stock, designating 81,000 shares of its authorized and unissued preferred stock as 8.00% Series A Convertible Perpetual Preferred Stock (the "Series A Preferred Stock") and establishing the preferences, limitations and relative rights of the Series A Preferred Stock. The Articles of Amendment became effective following the issuance of a certificate of amendment by the SCC to Precigen on December 30, 2024.
Amendment to the Articles of Incorporation - Increase of authorized shares
On July 25, 2025, Precigen filed articles of amendment (the "Authorized Shares Amendment") to its amended and restated articles of incorporation with the SCC, to increase Precigen's authorized shares of common stock to 700,000,000 from 400,000,000, which was previously approved by Precigen's shareholders on June 26, 2025. The Authorized Shares Amendment became effective following the issuance of a certificate of amendment by the SCC to Precigen on July 28, 2025.
Issuances of Preferred Stock and Warrants
On December 30, 2024, the Company issued 79,000 shares of the Series A Preferred Stock with an initial liquidation preference and stated value of $1,000 per share, together with the Warrants (see Note 5), for gross proceeds of $79,000 and net proceeds of $78,463, after deducting offering expenses, which have not been paid as of September 30, 2025. The aggregate exercise price of the Warrants is approximately $39,500, exercisable for an aggregate of 52,666,669 shares of common stock.
Mezzanine Classification
ASC 480-10-S99-3A(2) of the SEC's Accounting Series Release No. 268 ("ASR 268") requires preferred securities that are redeemable for cash or other assets to be classified outside of permanent equity if they are redeemable (i) at a fixed or determinable price on a fixed or determinable date, (ii) at the option of the holder, or (iii) upon the occurrence of an event that is not solely within the control of the issuer. Preferred securities that are mandatorily redeemable are required to be classified by the issuer as liabilities whereas under ASR 268, a company should classify a preferred security whose redemption is contingent on an event not entirely in control of the issuer as mezzanine equity. The Series A Preferred Stock was redeemable at the option of the holder upon a "fundamental change" (as defined in the Articles of Amendment) that is not solely within control of the Company, and accordingly, the Company determined that mezzanine treatment was appropriate for the Series A Preferred Stock prior to the conversion discussed below. Further, the Company previously evaluated all embedded features against an equity-like host and concluded none of the embedded features identified within the Series A Preferred Stock required bifurcation as they were either deemed clearly and closely related or not net settleable as a result of a lack of an active market.
The Series A Preferred Stock was initially measured at the amount of total proceeds less any offering costs and proceeds allocated to the Warrants, and is presented as such in our Condensed Consolidated Balance Sheet as of December 31, 2024. Additionally, during the six months ended June 30, 2025, the Company recorded an increase of $2,665 to the Series A Preferred Stock, which represented the fair value of the ratable portion of accumulated PIK dividends that would have increased the stated value of the Series A Preferred stock upon subsequent PIK dividend payment dates. Due to the absence of retained earnings, these adjustments to record the value of the PIK dividends were recorded as a reduction to additional paid-in capital.
Conversion of Preferred Stock
On September 15, 2025, all of the holders of the Series A Preferred Stock converted 79,000 shares of Preferred Stock (with an aggregate stated value of $79,000) into 54,937,411 shares of common stock of the Company, which were delivered to such holders on September 17, 2025 pursuant to the terms of the Amended and Restated Articles of Incorporation and such Preferred Stock at the then-current conversion rate of 695.4103 shares of common stock of the Company per $1,000 of stated value of Preferred Stock.
As the shares of Series A Preferred Stock were converted at the then-current conversion rate and therefore resulted in the delivery of a variable number of shares of the Company's common stock as compared to the original conversion terms at the time the Series A Preferred Stock agreement was entered into, the conversion was required to be treated as a redemption. In accordance with ASC 260, the Company compared (1) the fair value of the consideration transferred to the holders of the Series A Preferred Stock and (2) the carrying amount of the Series A Preferred Stock immediately before the exchange, with the difference treated as a return to the holders of the Series A Preferred Stock in a manner similar to dividends paid on preferred stock. Therefore, during September 2025, the Company recorded a $179,000 non-cash preferred stock deemed dividend as a reduction to additional paid-in capital, due to the absence of retained earnings.
Issuances of Precigen Common Stock
In August 2024, the Company closed a public offering of 39,878,939 shares of its common stock, resulting in net proceeds to the Company of $30,882, after deducting underwriting discounts, fees, and other offering expenses. This included the sale of 4,584,821 shares of the Company’s common stock pursuant to the underwriter’s exercise of its option to purchase additional shares. Of the 39,878,939 shares,23,588,234 shares were purchased by related parties and their affiliates, including the Company's Chairman of the Board of Directors and his affiliates, and one of the Company's executive officers.
Components of Accumulated Other Comprehensive Income (Loss)
The components of accumulated other comprehensive income consist solely of unrealized gain (loss), net on investments.
- Share-Based Payments
The Company measures the fair value of stock options, RSUs and PSUs issued to employees and nonemployees as of the grant date for recognition of stock-based compensation expense. Stock-based compensation expense for employees and nonemployees for which stock options and RSUs are issued, is recognized over the requisite service period, which is typically the vesting period. For PSUs, the Company recognizes stock-based compensation over the performance period, if it is probable that the performance condition will be achieved. Adjustments to PSU related stock-based compensation expense are made, as needed, each reporting period based on changes in the Company’s estimate of the number of units that are probable of vesting. Stock-based compensation costs included in the condensed consolidated statements of operations are presented below:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Cost of products and services | $5 | $10 | $23 | $29 |
| Research and development | 1,417 | 558 | 2,438 | 2,005 |
| Selling, general and administrative | 2,966 | 1,493 | 6,242 | 4,572 |
| Total | $4,388 | $2,061 | $8,703 | $6,606 |
The Company capitalized stock-based compensation associated with the allocation of labor costs related to work performed to manufacture Papzimeos of $0.1 in the three and nine months ended September 30, 2025.
Precigen Equity Incentive Plans
In August 2013, Precigen adopted the 2013 Omnibus Incentive Plan (the "2013 Plan"), for employees and nonemployees which provided for grants of share-based awards, including stock options, RSUs, shares of common stock and other awards, to employees, officers, consultants, advisors, and nonemployee directors. Upon the effectiveness of the Company's 2023 Omnibus Incentive Plan, as amended (the "2023 Plan") in June 2023, no new awards may be granted under the 2013 Plan and any awards granted under the 2013 Plan prior to the effectiveness of the 2023 Plan will remain outstanding under such plan and will continue to vest and/or become exercisable in accordance with their original terms and conditions. As of September 30, 2025, there were 14,943,527 stock options andno RSUs outstanding under the 2013 Plan.
In April 2023, Precigen adopted the 2023 Plan, which became effective upon shareholder approval in June 2023. The 2023 Plan permits the grant of share-based awards, including stock options, restricted stock awards, RSUs, PSUs and other awards, to officers, employees and nonemployees. The 2023 Plan authorizes for issuance pursuant to awards under the 2023 Plan an aggregate of 29,918,137 shares, which included shares remaining available for issuance under the 2013 Plan as of the adoption of the 2023 Plan plus an amendment to increase the number of shares of common stock which may be subject to awards thereunder by 2,000,000 shares, which was approved by Precigen's shareholders at Precigen's annual meeting on July 5, 2024, and subsequent amendment to increase the number of shares by 11,500,000, which was approved by Precigen's board of directors in May 2025 and subsequently approved by its shareholders at Precigen's annual meeting of shareholders held on June 26, 2025. As of September 30, 2025, there were 9,072,440 stock options,1,030,000 PSUs and 1,695,875 RSUs outstanding under the 2023 Plan and 11,460,993 shares were available for future grants.
In April 2019, Precigen adopted the 2019 Incentive Plan for Non-Employee Service Providers, as amended (the "2019 Plan"), which became effective upon shareholder approval in June 2019. The 2019 Plan permits the grant of share-based awards, including stock options, restricted stock awards, and RSUs, to non-employee service providers, including board members. As of September 30, 2025, there were 13,100,000 shares authorized for issuance under the 2019 Plan, which included shares remaining available for issuance under the 2019 Plan as of the adoption of the 2019 Plan plus an amendment to increase the number of shares of common stock which may be subject to awards thereunder by 1,100,000, which was approved by Precigen's board of directors in May 2025 and subsequently approved by its shareholders at Precigen's annual meeting of shareholders held on June 26, 2025. As of September 30, 2025, the 2019 Plan had 4,236,081 stock options and 646,551 RSUs outstanding and 2,048,892 shares were available for future grants.
Stock option activity was as follows:
| Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | |
|---|---|---|---|
| Balances at December 31, 2024 | 25,924,734 | $5.07 | 7.05 |
| Granted | 4,316,403 | 1.44 | |
| Exercised | (690,712) | (1.54) | |
| Forfeited | (331,106) | (1.66) | |
| Expired | (967,271) | (14.67) | |
| Balances at September 30, 2025 | 28,252,048 | 4.31 | 7.00 |
| Exercisable at September 30, 2025 | 18,179,777 | 5.91 | 6.09 |
The following table summarizes additional information about stock options outstanding as of September 30, 2025:
| Options Outstanding · Options Exercisable | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Range of Exercise Prices · Number of Options · Weighted Average Exercise Price · Weighted Average Remaining Life (Years) · Aggregate Intrinsic Value · Number of Options · Weighted Average Exercise Price · Weighted Average Remaining Life (Years) · Aggregate Intrinsic Value | |||||||||||
| $0.67 | — | $1.40 | 14,916,853 | $1.29 | 8.42 | $29,770 | 5,964,032 | $1.23 | 7.83 | $12,267 | |
| $1.41 | — | $2.33 | 5,728,448 | 1.97 | 7.12 | 7,540 | 4,675,748 | 1.96 | 7.07 | 6,200 | |
| $2.58 | — | $5.95 | 2,282,856 | 5.48 | 4.47 | 31 | 2,216,106 | 5.51 | 4.41 | 23 | |
| $6.06 | — | $11.90 | 2,773,556 | 10.14 | 4.70 | — | 2,773,556 | 10.14 | 4.70 | — | |
| $13.17 | — | $34.85 | 2,550,335 | 19.80 | 3.16 | — | 2,550,335 | 19.80 | 3.16 | — | |
| 28,252,048 | 28252048 | $4.31 | 7.00 | $37,341 | 18,179,777 | $5.91 | 6.09 | $18,490 | |||
PSUs and RSUs
In 2024, the Company's Compensation and Human Capital Management Committee of the Board of Directors (the "Compensation Committee") approved the grant of 3,178,000 PSUs under the 2023 Plan to certain key employees of the Company. Of the PSUs granted,2,978,000 were subject to vesting in two equal 50% installments based upon the achievement of two specified operational milestones relating to (i) the Company’s good faith submission to the FDA of a complete BLA for the Company’s PRGN-2012 investigational product and (ii) the approval of the BLA by the FDA (the "August 2024 PSUs"). The remaining 200,000 PSUs granted in 2024 are subject to vesting in two equal 50% installments based on (i) the achievement of the approval of the BLA by the FDA and (ii) continued employment with the Company through thesix-month anniversary of the approval of the BLA by the FDA (the “Additional 2024 PSUs”). In the second quarter of 2025, the Compensation Committee approved the grant of 950,000 PSUs under the 2023 Plan to non-executive employees of the Company, which are scheduled to vest one year from grant date, but only if the approval of the BLA by the FDA occurs prior to such date (the “2025 PSUs”).
The performance milestones of the August 2024 PSUs and Additional 2024 PSUs may be achieved (and the related PSUs earned) at any time through December 31, 2026 (the “Performance Period”), and the PSUs will vest and be settled in shares of the Company’s common stock at such time as the Compensation Committee certifies that an applicable performance milestone has been achieved, subject to the employee's continued employment through the applicable achievement date (subject to certain exceptions). Any PSUs for which a performance milestone has not been achieved by the end of the Performance Period will be cancelled and forfeited.
In January 2025, the Compensation Committee certified the achievement of the first performance milestone for the August 2024 PSUs related to the submission to the FDA of the BLA, and as such, approximately 1.5 million PSU shares vested in January 2025.
In September 2025, the Compensation Committee certified the achievement of the performance milestone for each of the
August 2024 PSUs, the Additional 2024 PSUs, and the 2025 PSUs, related to the approval of the BLA by the FDA, and as such, approximately 1.6 million PSU shares vested in September 2025.
With respect to the August 2024 PSUs, as of the award grant date, the underlying performance milestone relating to the Company's submission of a BLA to the FDA was considered probable of achievement and stock-based compensation expense was recognized during the year ended December 31, 2024 related to this milestone.
As of the award grant date, the underlying performance milestone related to the approval of the BLA by the FDA was determined to be not probable of achievement, as such approval is outside of the Company's control. Therefore, no stock-based compensation expense was recognized for the six months ended June 30, 2025 and during 2024 related to this milestone.
Upon approval of the BLA by the FDA, the performance condition was determined to be probable of being satisfied and therefore the Company recognized a cumulative catch-up adjustment of $2,266 to reflect the portion of the employee's requisite service that has been provided to date. For those PSUs with a continued service condition, the Company will continue to recognize stock compensation cost over the remaining requisite service period.
Additionally, in September 2025, the Company elected to settle in cash the August 2024 PSUs held by certain executive officers. These were accounted as cash settlements of equity-classified awards as it is not expected that the Company will have further settlements of any equity awards in cash. As such, the Company recorded compensation cost of $3,404, which represented the additional settlement consideration that exceeded the fair-value-based measure of the equity-classified on the settlement date.
RSU and PSU activity was as follows:
| Number of RSUs and PSUs | Weighted Average Grant Date Fair Value | Weighted Average Remaining Contractual Term (Years) | |
|---|---|---|---|
| Balances at December 31, 2024 | 4,004,057 | $1.16 | 0.55 |
| Granted | 6,867,489 | 1.42 | |
| Vested | (6,285,620) | (1.29) | |
| PSUs settled in cash | (1,154,000) | (1.11) | |
| Forfeited | (59,500) | (0.03) | |
| Balances at September 30, 2025 | 3,372,426 | 1.45 | 0.95 |
Precigen uses treasury shares (to the extent available) and authorized and unissued shares to satisfy share award exercises.
- Operating Leases
The Company leases certain facilities and equipment under operating leases. Leases with a lease term of twelve months or less are considered short-term leases and are not recorded on the balance sheet, and expense for these leases is recognized over the term of the lease. All other leases have remaining terms of less thanone year tofive years, some of which may include options to extend the lease and some of which may include options to terminate the lease withinone year. The Company uses judgment to determine whether it is reasonably possible to extend the lease beyond the initial term or terminate before the initial term ends and the length of the possible extension or early termination. The leases are renewable at the option of the Company and do not contain residual value guarantees, covenants, or other restrictions.
The components of lease costs were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Operating lease costs | $423 | $337 | $1,254 | $1,555 |
| Short-term lease costs | 9 | 11 | 27 | 46 |
| Variable lease costs | 105 | 92 | 285 | 276 |
| Lease costs | $537 | $440 | $1,566 | $1,877 |
As of September 30, 2025, maturities of lease liabilities, excluding short-term and variable leases were as follows:
| 2025 | $418 |
| 2026 | 1,695 |
| 2027 | 1,484 |
| 2028 | 1,360 |
| 2029 | 1,295 |
| 2030 | 553 |
| Thereafter | — |
| Total | $6,805 |
| Present value adjustment | (1,503) |
| Total | $5,302 |
| Current portion of operating lease liabilities | $1,123 |
| Long-term portion of operating lease liabilities | 4,179 |
| Total | $5,302 |
Other information related to operating leases was as follows:
| September 30,2025 | December 31,2024 | |
|---|---|---|
| Weighted average remaining lease term (years) | 4.16 | 4.83 |
| Weighted average discount rate | 11.46% | 11.57% |
| Nine Months Ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Supplemental disclosure of cash flow information | ||
| Cash paid for operating lease liabilities | $1,259 | $1,903 |
| Operating lease right-of-use assets obtained in exchange for new lease liabilities (includes new leases or modifications of existing leases) | 615 | 572 |
- Commitments and Contingencies
In December 2020, a derivative shareholder action, captioned Edward D. Wright, derivatively on behalf of Precigen, Inc. F/K/A Intrexon Corp. v. Alvarez et al, was filed in the Circuit Court for Fairfax County in Virginia on behalf of Precigen, Inc. The complaint named as defendants certain of the Company' directors and certain of the Company's current and former officers. The complaint's claims related to disclosures made by the Company about MBP program from May 10, 2017 to March 1, 2019. The plaintiff seeks damages, forfeiture of benefits received by defendants, and an award of reasonable attorneys' fees and costs. The case was stayed by an order entered on June 14, 2021. On September 24, 2021, an individual shareholder filed a lawsuit in the Circuit Court for Henrico County styled Kent v. Precigen, Inc., Case CL21-6349. The Kent action, also related to disclosures regarding MBP program, demands inspection of certain books and records of the Company pursuant to Virginia statutory and common law. On April 1, 2022, the court denied the demurrer and referred the matter to a hearing on the merits. In October 2025, the Kent action was dismissed by the court due to a lack of activity for the preceding three years. The Company intends to defend the remaining legal matters vigorously; however, there can be no assurances regarding the ultimate outcome of these lawsuits.
In August 2022, the Company completed the sale of 100% of the issued and outstanding membership interests in its wholly-owned subsidiary, Trans Ova, to Spring Bidco LLC (the “Buyer”), a Delaware limited liability company for $170,000 and up to $10,000 in cash earn-out payments contingent upon the performance of Trans Ova in each of 2022 and 2023, consisting of $5,000 for each year (the “Transaction”). In February 2023, the Buyer notified the Company that Trans Ova did not meet the financial measures required in 2022 in order to require the first $5,000 earn-out payment. In April 2024, the Buyer notified the Company that Trans Ova did not meet the financial measures required in 2023 in order to require the second $5,000 earn-out payment. After an arbitration process regarding this conclusion, it was determined that no payment was due to the Company related to the second $5,000 earn-out payment.
In connection with the sale of Trans Ova, the Company is required to indemnify the Buyer for certain expenses incurred post close (related to covenants and certain additional specified liabilities including certain patent infringement lawsuits), if incurred, in amounts not to exceed $5,750. Such indemnification was recorded as a reduction of the gain on divestiture in 2022. As of September 30, 2025 and December 31, 2024, $3,213 was included in indemnification accruals on the condensed consolidated balance sheets, respectively, related to this indemnification liability. During 2024, the Company paid $1,862 for expenses incurred by the Buyer for the period from July 2023 to December 2023. In addition, during 2023, the Company paid $675 for indemnification claims against this liability for the period from the date of sale to June 2023. In November 2025, the Company received an indemnification claim of $737 for expenses incurred by the buyer for the period from January 2024 to September 2025.
In the course of its business, the Company is involved in litigation or legal matters, including governmental investigations. Such matters may result in adverse judgments, unfavorable settlements, or concessions by the Company, or adverse regulatory action, any of which could harm the Company’s business or operations. Moreover, such matters are subject to many uncertainties and outcomes are not predictable with assurance. The Company accrues liabilities for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of September 30, 2025, the Company does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company's business, financial condition, results of operations, or cash flows.
- Segments
While the Company has historically generated revenues from multiple sources, including collaboration agreements and products and services associated with animal research models, management is organized around a singular focus which is developing and commercializing product candidates in its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
In February 2025, the FDA granted priority review to Company’s BLA for PRGN-2012, with a PDUFA target action date set for August 27, 2025. On August 14, 2025, the FDA fully approved Papzimeos, marking the Company’s transition from a development-stage to a commercial-stage biopharmaceutical company.
In anticipation of this transition, during the first quarter of 2025, the Company realigned its formertwo operating segments, Biopharmaceuticals and Exemplar, intoone operating segment. This decision was made to streamline operations and enhance focus on core business activities in preparation for the commercial launch of Papzimeos. The Company implemented this change to better reflect how the Company is managed and to align with its strategic initiative to concentrate resources on its core business. This change also reflects a shift in the manner in which the chief operating decision maker (“CODM”) reviews information to assess the Company’s performance and make resource allocation decisions, in accordance with ASC 280, Segment Reporting. The Company's CODM is its President and Chief Executive Officer ("CEO"). The CODM manages and allocates resources at a consolidated level.
Also, beginning in the first quarter of 2025, the CEO began using net loss in accordance with generally accepted accounting principles to assess performance and decide how to allocate resources. The CEO uses net loss to evaluate the allocation of resources across functions and research and development projects in line with our overarching long-term company-wide strategic goals as well as to monitor budget versus actual results. The CEO does not use total assets to evaluate segment performance or allocate resources, and accordingly, these amounts are not required to be disclosed. All prior period segment data has been retrospectively adjusted to reflect the way the Company's CODM internally receives information and manages and monitors our operating segment performance starting in fiscal year 2025.
The accounting policies of the Company's single operating segment are the same as those described in the summary of significant accounting policies as described in Note 2. As of September 30, 2025, substantially all of the Company's long-lived assets were held in the United States and there were no revenues derived in foreign countries for any periods presented. Expenditures for the addition of long-lived assets are reported on the consolidated statements of cash flows as purchases of property and equipment.
Total segment net loss, which equals consolidated net loss per the condensed consolidated statements of operations was as follows:
| Three Months Ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Revenues from external customers | $2,922 | $953 | $5,119 | $2,735 |
| Less: | ||||
| Salaries, benefits and other payroll expenses, including severance costs | (17,575) | (11,691) | (36,482) | (34,876) |
| Rent and Utilities | (983) | (939) | (2,788) | (3,052) |
| Change in fair value of Warrants liabilities | (111,502) | — | (139,523) | — |
| Impairment of Goodwill | — | — | (3,907) | (1,630) |
| Impairment of Assets | — | — | — | (32,915) |
| Other segment expenses, net | (19,206) | (12,301) | (49,558) | (36,770) |
| Net loss | $(146,344) | $(23,978) | $(227,139) | $(106,508) |
Other segment expenses, net in the table above includes external R&D costs including laboratory supplies, third-party commercialization and manufacturing costs, cost of sales, consultant costs, legal and professional fees, insurance, and certain other overhead expenses.
For the three months ended September 30, 2025 and 2024,62.2% and 63.0%, respectively, of total consolidated revenue was attributable toone customer in 2025 andfour in 2024. For the nine months ended September 30, 2025 and 2024,58.1% and 63.4%, respectively, of total consolidated revenue was attributed tothree customers in 2025 andfour customers in 2024.
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