PRECIGEN, INC.
For the period ended Mar 31, 2025. Filed May 14, 2025.
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Mar 31, 2025 · Filed May 14, 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 dedicated discovery and clinical-stage 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. Precigen’s leading product candidate is PRGN-2012, an AdenoVerse® gene therapy. Zopapogene imadenovec is the nonproprietary name for the investigational therapeutic known as PRGN-2012. Zopapogene imadenovec has not been approved by any health authority in any country for any indication. The United States Food and Drug Administration ("FDA") granted priority review to PRGN-2012 Biologics License Application ("BLA") with a Prescription Drug User Fee Act ("PDUFA") target action date set for August 27, 2025. This therapy is intended for the treatment of adults with recurrent respiratory papillomatosis ("RRP").
Precigen also hasone wholly owned operating subsidiary, consisting of Exemplar Genetics, LLC, doing business as Precigen Exemplar ("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 the PRGN-2012 AdenoVerse® gene therapy for the treatment of recurrent respiratory papillomatosis (RRP). These strategic changes were designed to reduce required resources for non-priority programs and enable the Company to focus on pre-commercialization efforts on PRGN-2012, including supporting the submission of a rolling BLA under an accelerated approval pathway which was filed in the fourth quarter of 2024, conducting a confirmatory clinical trial, and manufacturing commercial product. Additionally, the Company continues the acceleration of commercial readiness efforts for a potential launch in 2025. As a result of the actions taken related to the reduction in its workforce, the Company recorded a charge related to employee severance and termination benefits of $1,639 during 2024. As of March 31, 2025, $978 of the $1,639 charge was paid, leaving a liability of $661, which is included in accrued compensation and benefits on the condensed consolidated balance sheet.
Precigen and its consolidated subsidiaries are hereinafter referred to as the "Company." As discussed in Note 14, 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 March 31, 2025 and results of operations and cash flows for the interim periods ended March 31, 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 and Going Concern
During the three months ended March 31, 2025, the Company incurred a net loss of $54,153 and used $16,325 of cash in its operations, and as of March 31, 2025, had an accumulated deficit of $2,144,859. The Company has incurred operating losses since its inception and management expects operating losses and negative cash flows from operations, exclusive of cash sources outside of the Company’s direct control, including potential revenue from PRGN-2012 for the treatment of adults with RRP, to continue in the foreseeable future. In addition, as of March 31, 2025, the Company had $80,992 in cash, cash equivalents and short-term and long-term investments, and had no committed source of additional funding. Considering only the forecasted cash flows under its direct control, the Company's current cash and investments position, is not sufficient to fund the Company's planned operations for one year after the date the interim financial statements are issued and accordingly, these conditions and events raise substantial doubt about the Company's ability to continue as a going concern.
As the Company continues to incur losses, its transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support the Company's cost structure.
The analysis used to determine the Company's ability to continue as a going concern does not include cash sources outside of the Company's direct control that management expects to be available within the next twelve months, such as the potential revenue from PRGN-2012 for the treatment of adults with RRP. This potential revenue has been excluded as the BLA, which the FDA accepted and granted priority review in February 2025 (with a PDUFA target action date set for August 27, 2025), has not yet been approved.
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 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 non-core 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. If the approval of the PRGN-2012 BLA is delayed or not granted, and/or the Company is unable to obtain additional capital, the Company will assess its capital resources and may be required to delay, reduce the scope of, or eliminate some or all of its operations, which may include research and development and clinical trials. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company'sability to continue as a going concern.
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, 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. 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 March 31, 2025 and December 31, 2024, the Company had research and development commitments with third parties that had not yet been incurred totaling $4,911 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 March 31, 2025 and December 31, 2024 short-term and long-term investments include corporate bonds, United States government debt and agency securities 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. |
Pre-Launch Inventory
Prior to an initial regulatory authorization for our drug product candidates, we expense costs relating to raw materials and inventory production as research and development expenses in our consolidated statements of operations in the period incurred. We capitalize the costs of production as inventory when we believe regulatory authorization and subsequent commercialization are considered probable and we expect to realize future economic benefit from the sales of the drug product candidate. We have not capitalized any inventory to date related to drug products.
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. For purposes of the diluted net loss per share calculation, shares to be issued pursuant to stock options, restricted stock units ("RSUs") and performance stock units ("PSUs") 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 as described in the next paragraph, and therefore, basic and diluted net loss per share were the same for all periods presented.
In accordance with ASC 260, the control number for determining whether including potential common shares in the diluted earnings per share, or EPS, computation would be antidilutive should be income from continuing operations. As a result, if there is a loss from continuing operations, diluted EPS would be computed in the same manner as basic EPS is computed, even if the entity has net income after adjusting for a discontinued operation.
The following potentially dilutive securities as of March 31, 2025 and 2024, have been excluded from the above computations of diluted weighted average shares outstanding for the three months then ended as they would have been anti-dilutive:
| March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options | 25,898,681 | 22,715,549 |
| Restricted stock units | 773,311 | 786,709 |
| Performance stock units | 1,654,000 | — |
| Total | 28,325,992 | 23,502,258 |
The table above does not include approximately 70,222,215 shares of common stock initially underlying the Series A Preferred Stock and 52,666,669 shares of common stock, initially underlying the Warrants, as exercisability of the Series A Preferred Stock and the Warrants is contingent upon the Company increasing the number of authorized shares of common stock, which was not obtained as of March 31, 2025.
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 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 equity-classified warrants, the fair value is not remeasured. For warrants that are liability-classified, changes in fair value are included in Change in fair value of warrant liabilities in the Consolidated Statements of Operations.
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.
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.
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
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.
There was no collaboration and licensing revenue recognized during both the three months ended March 31, 2025 and 2024.
Deferred Revenue
Deferred revenue primarily consists 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:
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Collaboration and licensing agreements | $1,818 | $1,818 |
| Prepaid product and service revenues and other | 567 | 705 |
| Total | $2,385 | $2,523 |
| Current portion of deferred revenue | $549 | $589 |
| Long-term portion of deferred revenue | 1,836 | 1,934 |
| Total | $2,385 | $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 March 31, 2025:
| AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| U.S. government debt securities | $72,482 | $16 | $(6) | $72,492 |
| Certificates of deposit | 2,311 | 2 | — | 2,313 |
| Corporate bonds | 129 | — | — | 129 |
| Total | $74,922 | $18 | $(6) | $74,934 |
The estimated fair value of available-for-sale investments classified by their contractual maturities as of March 31, 2025 was:
| Due within one year | $74,184 |
|---|---|
| After one year through two years | 750 |
| Total | $74,934 |
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 March 31, 2025 and December 31, 2024, the Company held U.S. government debt securities valued at $3,868 and $24,169, respectively, which were included in cash and cash equivalents in the condensed consolidated balance sheet 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
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 March 31, 2025:
| Quoted Prices in Active Markets(Level 1) | Significant Other Observable Inputs(Level 2) | Significant Unobservable Inputs(Level 3) | March 31,2025 | |
|---|---|---|---|---|
| Assets | ||||
| U.S. government debt securities | $— | $72,492 | $— | $72,492 |
| Certificates of deposit | — | 2,313 | — | 2,313 |
| Corporate bonds | — | 129 | — | 129 |
| Total | $— | $74,934 | $— | $74,934 |
| Liabilities | ||||
| Warrant liabilities - 2024 Warrants | $— | $— | $83,018 | $83,018 |
| Total liabilities | $— | $— | $83,018 | $83,018 |
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 |
| Liabilities | ||||
| Warrant liabilities - 2024 Warrants | $— | $— | $50,537 | $50,537 |
| Total liabilities | $— | $— | $50,537 | $50,537 |
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.
Warrant liabilities
The Warrant liabilities (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.
The Warrants were accounted for as liabilities as the Warrants provide 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 10), 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"), upon obtaining Shareholder Approval (as defined in Note 10) which fails the requirement of the indexation guidance under ASC 815-40. Furthermore, the Company does not have a sufficient number of authorized and unissued shares available to share settle the instrument and for that reason the Warrants cannot be accounted as an equity-linked instrument. The Warrants and PIK Warrants (together the "Warrant liabilities") are measured at fair value at inception. The fair value of the outstanding Warrants is re-measured at fair value at the end of each reporting period, unless and until they are reclassified to equity.
The Company uses 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, we make 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 is based on the time to expiration of the Warrants from the date of measurement.
The fair value of the Warrants is 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 March 31, 2025, include (i) volatility of 86.9% (discounted for lack of marketability), (ii) risk free interest rate of 4.17%, (iii) strike price ($0.75), (iv) fair value of common stock ($1.49), and (v) expected life of 9 years, 9 months. As of December 31, 2024, the significant assumptions included (i) volatility of 86% (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 is estimated using a Black-Scholes option pricing model within a Monte Carlo simulation model framework. The significant assumptions used in preparing the simulation model for valuing the PIK Warrant as of March 31, 2025, include (i) volatility of 86.9% (discounted for lack of marketability), (ii) risk free interest rate range of 4.18% to 4.24%, (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 $0.19 to $4.79. 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 4.13% to
4.20%, (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.
During the three months ended March 31, 2025, the Company recorded expenses of $32,481 related to the change in the fair value of the Warrants liabilities within other income (expense), net in the accompanying Condensed Consolidated Statement of Operations.
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 is recorded as a reduction to additional paid-in capital.See Note 10 for further discussion on PIK dividends.
The fair value of the PIK dividend was estimated using significant unobservable inputs (Level 3) by conducting a discounted cash flow analysis. As of March 31, 2025, the significant assumptions include, (i) stock price of $1.49, (ii) term of 30 years, (iii) volatility of 86.86%, (iv) risk free rate of 4.54%, and (v) risky discount rate of 25%.
PIK dividends of $1,300 is included in Series A Preferred Stock on the accompanying Condensed Balance Sheet as of March 31, 2025.
- Property, Plant and Equipment, Net
Property, plant and equipment consist of the following:
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Land and land improvements | $164 | $164 |
| Buildings and building improvements | 2,629 | 2,629 |
| Furniture and fixtures | 364 | 364 |
| Equipment | 16,773 | 16,774 |
| Leasehold improvements | 4,487 | 4,478 |
| Breeding stock | 90 | 88 |
| Computer hardware and software | 3,210 | 3,186 |
| Construction and other assets in progress | 10,131 | 9,019 |
| 37,848 | 36,702 | |
| Less: Accumulated depreciation and amortization | (23,180) | (22,871) |
| Property, plant and equipment, net | $14,668 | $13,831 |
Depreciation expense was $310 and $380 for the three months ended March 31, 2025 and 2024, respectively.
- Goodwill and Intangible Assets, Net
The carrying amount of goodwill was $19,139 as of March 31, 2025 and December 31, 2024.
The Company had $32,282 of cumulative impairment losses as of March 31, 2025 and December 31, 2024.
Intangible assets consist of the following as of March 31, 2025:
| Gross Carrying Amount | Accumulated Amortization | Net | |
|---|---|---|---|
| Patents, developed technologies and know-how | $15,912 | $(11,776) | $4,136 |
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 were $319 and $1,215 for the three months ended March 31, 2025 and 2024, respectively.
- Debt
Line of Credit
Exemplar has a $5,000 revolving line of credit with American State Bank that matures on November 1, 2025. As of March 31, 2025 and December 31, 2024, the line of credit bore interest at a stated rate of 8.00% per annum. As of March 31, 2025 and December 31, 2024, there wasno outstanding balance.
- 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 wasno income tax expense or benefit for thethree months ended March 31, 2025, and $29 of income tax benefit for thethree months ended March 31, 2024. 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.
- Mezzanine Equity and Shareholders' Equity (Deficit)
Under the Company’s amended and restated articles of incorporation the Company is authorized to issue 400,000,000 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.
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 had not been paid as of March 31, 2025. The aggregate exercise price of the Warrants is approximately $39,500, exercisable for an aggregate of 52,666,669 shares of common stock. The terms of the Series A Preferred Stock are summarized below.
Series A Preferred Stock Rights:
Dividend. Dividends on the Series A Preferred Stock will be paid annually in cash at a rate of 8.00% when, as and if declared by the board of directors of Precigen, except that for the firsttwo years following the issue date of the Series A Preferred Stock, such dividends will be paid in kind in the form of an increase to the stated value and the liquidation preference of the Series A Preferred Stock by the amount of such dividends, together with Warrants to acquire a number of additional shares of common stock equal to 50% of the amount of such dividends divided by the $0.75 exercise price of the Warrants, subject to the Shareholder Approval (as described below).
Redemption. The Series A Preferred Stock is redeemable, in whole or in part, for cash at Precigen’s option at any time. The redemption price will be equal to the stated value of the Series A Preferred Stock to be redeemed, plus accumulated and unpaid dividends, if any, to, but excluding, the redemption date. If a fundamental change occurs (as defined in the Articles of Amendment), then holders of the Series A Preferred Stock may require Precigen to repurchase their shares of Series A Preferred Stock for cash. The repurchase price will be equal to the stated value of the shares of Series A Preferred Stock to be repurchased, plus accumulated and unpaid dividends, if any, to, but excluding, the repurchase date.
Conversion. The Series A Preferred Stock will be convertible into common stock at the option of the holders of the Series A Preferred Stock at any time on or after the later of the six-month anniversary of the issue date of the Series A Preferred Stock and the date on which Precigen has, among other things, obtained (1) any shareholder approval that may be required under the listing rules of the Nasdaq Global Select Market, (2) any shareholder approval that may be required to increase the number of authorized shares of common stock sufficient to permit the exercise of the Warrants and to permit the conversion of the Series A Preferred Stock into the maximum number of shares of common stock deliverable upon conversion of all shares of Series A Preferred Stock no later than 180 days after December 30, 2024 and (3) the filing with the SCC and the effectiveness of an amendment to Precigen’s amended and restated articles of incorporation evidencing such shareholder approval (collectively, the “Shareholder Approval”). The Series A Preferred Stock will also be convertible into common stock at Precigen’s option at any time on or after the third anniversary of the issue date of the Series A Preferred Stock, but only if the closing sale price per share of common stock equals or exceeds $4.00 for a specified period of time and certain other conditions are satisfied. The Series A Preferred Stock is initially convertible into shares of common stock at a conversion rate of 888.8888 shares of common stock per $1,000 of stated value, for an initial conversion price of approximately $1.125 per share. However, if the arithmetic average of the closing sale prices of the common stock over the five trading day period ending on, and including, the last trading day of the fiscal quarter immediately preceding any conversion date exceeds the conversion price otherwise in effect on such conversion date, then the conversion rate for purposes of such conversion will be a number of shares of common stock per $1,000 of stated value equal to $1,000 divided by such arithmetic average. The conversion rate is also subject to customary adjustments.
The Series A Preferred Stock has no maturity date, ranks senior to the outstanding shares of common stock with respect to the payment of dividends and distributions in liquidation and has a liquidation preference equal to its stated value plus any accrued and unpaid dividends (whether or not declared). Subject to certain limited exceptions, the Series A Preferred Stock and the Warrants are not transferable forsix months from the issue date.
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 is redeemable at the option of the holder upon a "fundamental change" (as defined in the agreements) that is not solely within control of the Company, and accordingly, the Company determined that mezzanine treatment is appropriate for the Series A Preferred Stock.
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. As disclosed in Note 5, for the three months ended March 31, 2025, the Company recorded $1,300 for PIK dividends, increasing the value of the Series A Preferred Stock on the Condensed Consolidated Balance Sheet at March 31, 2025 and reducing Additional Paid-In Capital (as the Company does not have retained earnings) in the Condensed Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit) for the three months ended March 31, 2025. Further, the Company evaluated all embedded features against an equity-like host and concluded none of the embedded features identified within the Series A Preferred Stock require bifurcation as they are either deemed clearly and closely related or not net settleable as a result of a lack of an active market.
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) 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 March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Cost of products and services | $11 | $17 |
| Research and development | 558 | 533 |
| Selling, general and administrative | 2,108 | 2,031 |
| Total | $2,677 | $2,581 |
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 March 31, 2025, there were 15,704,897 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 18,418,137 shares, which included shares remaining available for issuance under the 2013 Plan as of the adoption of the 2023 Plan plus an increase of 2,000,000 shares of common stock, which was approved by Precigen's shareholders at Precigen's annual meeting on July 5, 2024. As of March 31, 2025, there were 5,756,083 stock options,1,654,000 PSUs andno RSUs outstanding under the 2023 Plan and 7,510,697 shares were available for future grants.
In April 2019, Precigen adopted the 2019 Incentive Plan for Non-Employee Service Providers (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 March 31, 2025, there were 12,000,000 shares authorized for issuance under the 2019 Plan, of which 4,437,701 stock options and 773,311 RSUs were outstanding and 747,272 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 | 866,153 | 1.66 | |
| Exercised | (144,487) | (1.12) | |
| Forfeited | (298,167) | (1.69) | |
| Expired | (449,552) | (23.03) | |
| Balances at March 31, 2025 | 25,898,681 | 4.70 | 6.99 |
| Exercisable at March 31, 2025 | 16,629,422 | 6.44 | 6.08 |
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, are 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 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 performance milestones 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 first performance milestone related to the submission to the FDA of the BLA had been achieved, and as such, approximately 2.1 million PSU shares vested during the three months ended March 31, 2025.
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 | 646,551 | 1.74 | |
| Vested | (2,188,297) | (1.21) | |
| Forfeited | (35,000) | (1.13) | |
| Balances at March 31, 2025 | 2,427,311 | 1.27 | 0.57 |
As of the award 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 three months ended March 31, 2025 and during 2024 related to this milestone.
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 ofone tosix 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 March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating lease costs | $416 | $609 |
| Short-term lease costs | 10 | 13 |
| Variable lease costs | 90 | 92 |
| Lease costs | $516 | $714 |
As of March 31, 2025, maturities of lease liabilities, excluding short-term and variable leases, for continuing operations were as follows:
| 2025 | $1,125 |
| 2026 | 1,572 |
| 2027 | 1,358 |
| 2028 | 1,263 |
| 2029 | 1,295 |
| 2030 | 553 |
| Thereafter | — |
| Total | $7,166 |
| Present value adjustment | (1,749) |
| Total | $5,417 |
| Current portion of operating lease liabilities | $928 |
| Long-term portion of operating lease liabilities | 4,489 |
| Total | $5,417 |
Other information related to operating leases in continuing operations was as follows:
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Weighted average remaining lease term (years) | 4.57 | 4.83 |
| Weighted average discount rate | 11.51% | 11.57% |
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Supplemental disclosure of cash flow information | ||
| Cash paid for operating lease liabilities | $416 | $572 |
| Operating lease right-of-use assets obtained in exchange for new lease liabilities (includes new leases or modifications of existing leases) | 297 | 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. The Company intends to defend the lawsuits 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. The Company has disputed certain items reflected in the 2023 financial measures presented by the Buyer in the aforementioned notification.
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 the third quarter of 2022. As of March 31, 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 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 March 31, 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. During the three months ended March 31, 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 anticipation of a potential 2025 product launch. The Company implemented this change to better reflect how the Company is managed and its strategic initiative to concentrate resources on its core business line reflects a change in the manner in which the chief operating decision maker (“CODM”), reviews information to assess the Company’s performance and make decisions about resource allocation, 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 March 31, 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 March 31, 2025 | Three Months Ended March 31, 2024 | |
|---|---|---|
| Revenues from external customers | $1,341 | $1,065 |
| Less: | ||
| Salaries, benefits and other payroll expenses, including severance costs | (9,186) | (10,788) |
| Rent and Utilities | (931) | (1,011) |
| Unrealized appreciation in fair value of Warrants liabilities | (32,481) | — |
| Other segment expenses, net | (12,896) | (13,004) |
| Net loss | $(54,153) | $(23,738) |
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 March 31, 2025 and 2024,49.9% and 52.8%, respectively, of total consolidated revenue was attributable tofour customers in 2025 andthree customers in 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.