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Undercovered Dozen: Precigen, ONEOK, Bitmine And More
Seeking Alpha· 2025-08-22 14:43
Group 1 - The article introduces "The Undercovered Dozen," highlighting twelve actionable investment ideas on tickers with less coverage, which can include both large caps and small caps [1] - Inclusion criteria for "undercovered" tickers are specified: market cap greater than $100 million, more than 800 symbol page views in the last 90 days on Seeking Alpha, and fewer than two articles published in the past 30 days [1] - The initiative aims to provide a weekly review of these undercovered ideas from analysts, indicating a focus on identifying potential investment opportunities that may not be widely recognized [1]
Precigen (PGEN) Update / Briefing Transcript
2025-08-18 13:00
Summary of Precigen (PGEN) Conference Call - August 18, 2025 Company Overview - **Company**: Precigen (PGEN) - **Product**: PapSimios - **Indication**: Treatment of adults with recurrent respiratory papillomatosis (RRP) - **FDA Approval**: First and only FDA-approved therapy for RRP Key Points and Arguments FDA Approval and Significance - PapSimios received full FDA approval, eliminating the need for a confirmatory study, marking a significant milestone for the RRP community [2][4] - This approval transforms Precigen into a commercial-stage company, allowing for efficient market entry [4] Disease Overview - RRP is a rare, chronic disease caused by HPV types 6 and 11, primarily managed through surgical interventions until now [5] - Estimated patient population in the U.S. is approximately 27,000 adults [5][39] Treatment Efficacy - PapSimios targets the underlying cause of RRP, generating an immune response against HPV-infected papillomas [10] - 51% of treated patients met the primary endpoint of a complete response, defined as no surgical intervention needed for at least 12 months [10] - Durable responses observed, with 15 of 18 complete responders maintaining their response at two years [10] Commercial Strategy - PapSimios is positioned to become the standard of care for adult RRP patients due to its broad label and clinical durability [11][12] - The product is priced at $115,000 for a complete treatment course (four vials) [22][27] - Focus on integrated delivery networks (IDNs) and community hospitals, which account for over 90% of the patient population [12][13] Launch Execution - A robust commercial infrastructure is in place, with dedicated sales territories covering over 90% of ENT patient potential [13] - Preapproval information exchange has established relationships with key healthcare providers [14] - Comprehensive patient support program includes financial assistance, treatment education, and insurance navigation [17][18] Market Access and Payer Engagement - High anticipation from payers regarding the unmet need and clinical efficacy of PapSimios [31] - Discussions with payers indicate a strong likelihood of broad access for all eligible patients [31] Future Considerations - Potential for redosing to enhance immune responses in partial or non-responders, based on clinical data [32] - Ongoing monitoring of prescription metrics and market access metrics to track commercial success [16] Additional Important Content - Collaboration with the RRP Foundation to leverage patient databases for targeting and ensuring access to treatment [24][26] - The approval of PapSimios represents a historic milestone for the RRP community, providing a long-awaited therapeutic option after a century of reliance on surgical interventions [39][40]
Precigen (PGEN) Earnings Call Presentation
2025-08-18 12:00
Product & Indication - PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with Recurrent Respiratory Papillomatosis (RRP)[11, 44, 55] - PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis[27] - The recommended dose of PAPZIMEOS is 5×10^11 particle units (PU) per injection, administered subcutaneously four times over a 12-week interval[27] Clinical Data - The pivotal study demonstrated a 51% Complete Response Rate (95% CI [34-69%])[37] - 15 out of 18 Complete Responders evaluated at 2 years demonstrated continued Complete Response[37] - PAPZIMEOS was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2[37] Commercial Strategy & Launch - The company is employing a targeted launch strategy with a field team covering >90% of ENT patient potential[47] - 93 IDNs and community hospitals account for 80% of initial target potential, with a total target universe of ~500 accounts[48] - 18 dedicated sales territories will cover >90% of ENT patient potential[47] RRP Market - Approximately 27,000 adult patients in the US have RRP[16] - IDNs and Community hospitals account for >90% of identified patient potential[46]
Precigen: This Billion-Dollar Approval Is Still Undervalued
Seeking Alpha· 2025-08-15 19:15
Group 1 - The article discusses the investment analysis approach of Stephen, who combines his background as a registered nurse (RN) and an MBA to evaluate healthcare and tech stocks [1] - Stephen utilizes a proprietary system called the "Dizzy Framework," designed to mitigate common behavioral errors in investing, such as reacting to market noise or adhering too rigidly to prior beliefs [1] - The framework emphasizes the importance of the quality and timing of information, promoting a patient and disciplined investment strategy that translates complex scientific and market dynamics into actionable investment theses [1] Group 2 - Influences on Stephen's investment philosophy include concepts from "Superforecasting" and "Fooled by Randomness," which highlight the unpredictability of markets and the importance of probabilistic thinking in investment decisions [1]
Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
Prnewswire· 2025-08-15 11:00
Core Insights - Precigen, Inc. announced the FDA approval of PAPZIMEOS™ (zopapogene imadenovec-drba) as the first and only therapy for adults with recurrent respiratory papillomatosis (RRP) [1][4] - The approval was granted under an accelerated pathway, eliminating the need for a confirmatory clinical trial [1][4] - PAPZIMEOS is designed to target the root cause of RRP, which is chronic HPV 6 or HPV 11 infection, through a non-replicating adenoviral vector-based immunotherapy [1][10] Company Overview - Precigen specializes in innovative precision medicines aimed at improving patient lives and has a commitment to advancing scientific breakthroughs from discovery to commercialization [16] - The company has developed PAPZIMEOS using its proprietary AdenoVerse therapeutic platform, representing a new therapeutic paradigm for RRP [10][16] Industry Context - RRP is a rare and debilitating disease affecting approximately 27,000 adult patients in the US, leading to significant health burdens and reliance on repeated surgeries [4][9] - The approval of PAPZIMEOS is seen as a historic milestone for the RRP community, providing hope for patients who have endured extensive surgical interventions [3][4] Clinical Study Results - The pivotal study demonstrated that 51% of patients (18 out of 35) achieved a Complete Response, with no surgeries required in the 12 months following treatment [5] - The treatment was well-tolerated, with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 [5] Future Plans - Precigen plans to promote PAPZIMEOS immediately and has established a patient support program to assist with access to the therapy [7] - A conference call is scheduled for August 18 to discuss the approval and commercialization details [8]
Precigen(PGEN) - 2025 Q2 - Quarterly Report
2025-08-12 20:29
[Special Note Regarding Forward-Looking Statements](index=4&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This report contains forward-looking statements subject to substantial risks and uncertainties, cautioning readers that actual results may differ materially - This Quarterly Report contains forward-looking statements involving **substantial risks and uncertainties**, covering strategy, future events, operations, financial position, costs, prospects, and market growth. Readers are cautioned not to place undue reliance on these statements, as **actual results could differ materially** due to factors discussed in the report, particularly in 'Risk Factors'[10](index=10&type=chunk)[12](index=12&type=chunk)[13](index=13&type=chunk) [PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section details the unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) This section presents Precigen's unaudited condensed consolidated financial statements, detailing its financial position, performance, and cash flows [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The Condensed Consolidated Balance Sheets provide a snapshot of the company's financial position, showing a decrease in total assets and a shift from shareholders' equity to a deficit | Metric (in millions) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $13.76 | $29.52 | | Short-term investments | $45.99 | $68.39 | | Total current assets | $62.76 | $102.41 | | Total assets | $101.90 | $145.27 | | Total current liabilities | $23.19 | $21.52 | | Warrant liabilities | $78.56 | $50.54 | | Total liabilities | $107.79 | $78.54 | | Series A Preferred Stock (Mezzanine equity) | $30.88 | $28.22 | | Total shareholders' (deficit) equity | $(36.78) | $38.51 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a reduced net loss for both the three and six months ended June 30, 2025, primarily due to lower operating expenses despite increased SG&A | Metric (in millions, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $0.86 | $0.72 | $2.20 | $1.78 | | Operating expenses | $32.62 | $61.56 | $56.56 | $87.03 | | Operating loss | $(31.76) | $(60.84) | $(54.36) | $(85.25) | | Change in fair value of warrant liabilities | $4.46 | $— | $(28.02) | $— | | Total other (expense) income, net | $5.12 | $0.36 | $(26.43) | $1.00 | | Net loss | $(26.64) | $(58.79) | $(80.80) | $(82.53) | | Net loss per share, basic and diluted | $(0.09) | $(0.23) | $(0.27) | $(0.33) | [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The Condensed Consolidated Statements of Comprehensive Loss show a significant reduction in comprehensive loss for Q2 2025, while the six-month loss remained stable | Metric (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(26.64) | $(58.79) | $(80.80) | $(82.53) | | Other comprehensive loss: | | | | | | Unrealized (loss) gain on investments | $(0.00) | $0.02 | $(0.00) | $0.02 | | Loss on foreign currency translation adjustments | $— | $(0.13) | $— | $(0.98) | | Comprehensive loss | $(26.64) | $(58.90) | $(80.80) | $(83.49) | [Condensed Consolidated Statements of Mezzanine Equity and Shareholders' Equity (Deficit)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Mezzanine%20Equity%20and%20Shareholders%27%20Equity%20%28Deficit%29) The statements reflect a shift from shareholders' equity to a deficit as of June 30, 2025, primarily due to net loss and PIK dividends on preferred stock | Metric (in millions, except share data) | June 30, 2025 | December 31, 2024 | | :--------------------------------------- | :------------ | :---------------- | | Preferred Stock (Mezzanine Equity) | $30.88 | $28.22 | | Additional Paid-in Capital | $2,134.71 | $2,129.21 | | Accumulated Deficit | $(2,171.50) | $(2,090.71) | | Total Shareholders' (Deficit) Equity | $(36.78) | $38.51 | - PIK dividends on preferred stock increased mezzanine equity by **$1.37 million** for the three months ended June 30, 2025, and **$2.67 million** for the six months ended June 30, 2025, contributing to the change in equity structure[27](index=27&type=chunk)[28](index=28&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, the company experienced a net decrease in cash due to operating and financing activities, partially offset by investing activities | Cash Flow Activity (in millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(35.30) | $(37.20) | | Net cash provided by investing activities | $21.98 | $39.00 | | Net cash (used in) provided by financing activities | $(2.44) | $0.05 | | Effect of exchange rate changes | $0.01 | $(0.10) | | Net (decrease) increase in cash | $(15.76) | $1.76 | [Notes to the Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes provide comprehensive disclosures and explanations for the condensed consolidated financial statements, detailing operational focus, accounting policies, and financial information [1. Organization](index=13&type=section&id=1.%20Organization) Precigen is a discovery and clinical-stage biopharmaceutical company focused on gene and cell therapies, strategically prioritizing PRGN-2012 and operating as a single segment - Precigen is a dedicated discovery and clinical-stage biopharmaceutical company advancing gene and cell therapies, with a primary focus on immuno-oncology, autoimmune disorders, and infectious diseases[36](index=36&type=chunk) - The lead product candidate, PRGN-2012, an AdenoVerse® gene therapy for recurrent respiratory papillomatosis (RRP), received priority review for its Biologics License Application (BLA) from the FDA, with a PDUFA target action date of August 27, 2025[36](index=36&type=chunk) - In 2024, the company initiated a strategic prioritization, including the shutdown of ActoBio operations and a reduction of over **20%** of its workforce, to focus resources on the potential commercialization of PRGN-2012[39](index=39&type=chunk)[40](index=40&type=chunk) [2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the basis of presentation for unaudited financial statements, addresses going concern status, and details accounting policies for R&D, investments, and financial instruments - The company incurred a net loss of **$80.80 million** and used **$35.30 million** cash in operations for the six months ended June 30, 2025, resulting in an accumulated deficit of **$2.17 billion**, raising **substantial doubt about its ability to continue as a going concern**[44](index=44&type=chunk) - Warrants are classified as liability-classified instruments, with changes in fair value included in the Consolidated Statements of Operations, due to a feature allowing for additional warrants via PIK dividends on Series A Preferred Stock[60](index=60&type=chunk)[78](index=78&type=chunk) - Series A Preferred Stock is classified as 'mezzanine equity' because its redemption is contingent on events not solely within the company's control, such as a 'fundamental change' at the option of the holder[61](index=61&type=chunk)[105](index=105&type=chunk) [3. Collaboration and Licensing Revenue](index=17&type=section&id=3.%20Collaboration%20and%20Licensing%20Revenue) The company recognized no collaboration and licensing revenue for the reported periods, with deferred revenue primarily from historical agreements - **No collaboration and licensing revenue was recognized** during the three and six months ended June 30, 2025, and 2024[69](index=69&type=chunk) | Deferred Revenue (in millions) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Collaboration and licensing agreements- Long-term liability | $1.82 | $1.82 | | Prepaid product and service revenues - Short-term liability | $0.41 | $0.71 | | Total | $2.23 | $2.52 | [4. Investments](index=17&type=section&id=4.%20Investments) The company's available-for-sale investments, primarily U.S. government debt securities, decreased to $46.0 million as of June 30, 2025, with all investments due within one year | Available-for-Sale Investments (in millions) | June 30, 2025 | December 31, 2024 | | :-------------------------------------------- | :------------ | :---------------- | | U.S. government debt securities | $43.46 | $67.47 | | Certificates of deposit | $2.47 | $0.85 | | Corporate bonds | $0.06 | $0.07 | | Total Fair Value | $45.99 | $68.39 | - **All available-for-sale investments were classified as due within one year** for both periods[73](index=73&type=chunk) [5. Fair Value Measurements](index=18&type=section&id=5.%20Fair%20Value%20Measurements) Financial assets and liabilities are measured at fair value, with warrant liabilities and PIK dividends on preferred stock valued using Level 3 unobservable inputs | Financial Instrument (in millions) | June 30, 2025 | December 31, 2024 | | :---------------------------------- | :------------ | :---------------- | | Warrant liabilities | $78.56 | $50.54 | - The company recorded a non-cash gain of **$4.46 million** for the three months ended June 30, 2025, and a non-cash expense of **$28.02 million** for the six months ended June 30, 2025, related to the change in fair value of warrant liabilities[83](index=83&type=chunk) - Accrued PIK dividends of **$2.67 million** are included in Series A Preferred Stock as of June 30, 2025, valued using a discounted cash flow analysis with significant unobservable inputs (Level 3)[85](index=85&type=chunk)[86](index=86&type=chunk) [6. Property, Plant and Equipment, Net](index=20&type=section&id=6.%20Property%2C%20Plant%20and%20Equipment%2C%20Net) Property, plant and equipment, net, increased slightly to $14.7 million as of June 30, 2025, with decreased depreciation expense compared to the prior year | Metric (in millions) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Property, plant and equipment, net | $14.70 | $13.83 | | Depreciation Expense (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Depreciation expense | $0.31 | $0.39 | $0.62 | $0.77 | [7. Goodwill and Intangible Assets, Net](index=21&type=section&id=7.%20Goodwill%20and%20Intangible%20Assets%2C%20Net) Goodwill decreased to $15.2 million due to a $3.9 million impairment charge, while intangible assets and amortization expense also decreased | Metric (in millions) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Goodwill | $15.23 | $19.14 | | Intangible assets, net | $3.82 | $4.46 | - An impairment charge of **$3.91 million** was recorded in the second quarter of 2025 for the Exemplar reporting unit due to lowered financial expectations[89](index=89&type=chunk)[90](index=90&type=chunk) | Amortization Expense (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Amortization expense | $0.32 | $1.21 | $0.64 | $2.42 | [8. Debt](index=21&type=section&id=8.%20Debt) Exemplar Genetics maintains a $5.0 million revolving line of credit with American State Bank, maturing November 1, 2025, with no outstanding balance - Exemplar has a **$5.00 million** revolving line of credit with American State Bank, maturing on November 1, 2025, at an **8.00%** interest rate[92](index=92&type=chunk) - There was **no outstanding balance** on the line of credit as of June 30, 2025, and December 31, 2024[92](index=92&type=chunk) [9. Income Taxes](index=21&type=section&id=9.%20Income%20Taxes) The company recorded minimal income tax expense, with a valuation allowance offsetting net deferred tax assets due to a history of net losses | Income Tax (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Income tax (expense) benefit | $(0.00) | $1.69 | $(0.00) | $1.72 | - The company's net deferred tax assets are offset by a valuation allowance due to its history of net losses and inability to confirm recovery of tax benefits[95](index=95&type=chunk) [10. Mezzanine Equity and Shareholders' Equity (Deficit)](index=22&type=section&id=10.%20Mezzanine%20Equity%20and%20Shareholders%27%20Equity%20%28Deficit%29) Precigen increased authorized common stock to 700 million shares, and issued Series A Preferred Stock and warrants for $79 million gross proceeds, with preferred stock classified as mezzanine equity - On July 25, 2025, Precigen increased its authorized **shares** of common stock to **700 million shares**[98](index=98&type=chunk) - On December 30, 2024, the company issued **79 thousand shares** of **8.00%** Series A Convertible Perpetual Preferred Stock and warrants to purchase **52.67 million shares** of common stock for gross proceeds of **$79.00 million**[99](index=99&type=chunk) - Dividends on the Series A Preferred Stock are paid in kind for the first **two years**, increasing the stated value and liquidation preference, and the stock is convertible into common stock at the holder's option[100](index=100&type=chunk)[102](index=102&type=chunk) - The Series A Preferred Stock is classified as mezzanine equity because it is redeemable at the option of the holder upon a 'fundamental change' not solely within the company's control[105](index=105&type=chunk) [11. Share-Based Payments](index=24&type=section&id=11.%20Share-Based%20Payments) The company recognized $1.6 million in stock-based compensation for Q2 2025 and $4.3 million for YTD 2025, with 1.5 million PSU shares vesting upon BLA submission | Stock-Based Compensation Expense (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total | $1.64 | $1.96 | $4.32 | $4.54 | - Approximately **1.5 million shares** vested during the six months ended June 30, 2025, following the certification of the first performance milestone related to the submission of the BLA for PRGN-2012 to the FDA[116](index=116&type=chunk) - The performance milestone related to FDA approval of the BLA for PRGN-2012 was determined to be **not probable of achievement** as of the award grant date, and thus **no stock-based compensation expense was recognized** for this milestone[117](index=117&type=chunk)[118](index=118&type=chunk) [12. Operating Leases](index=26&type=section&id=12.%20Operating%20Leases) Operating lease costs decreased, with total lease liabilities of $5.15 million and a weighted average remaining lease term of 4.40 years as of June 30, 2025 | Lease Costs (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease costs | $0.42 | $0.61 | $0.83 | $1.22 | | Short-term lease costs | $0.01 | $0.02 | $0.02 | $0.04 | | Variable lease costs | $0.09 | $0.09 | $0.18 | $0.18 | | Total Lease costs | $0.51 | $0.72 | $1.03 | $1.44 | | Lease Liabilities (in millions) | June 30, 2025 | | :------------------------------- | :------------ | | Total lease liabilities | $5.15 | | Current portion | $0.93 | | Long-term portion | $4.22 | - The weighted average remaining lease term was **4.40 years** as of June 30, 2025[122](index=122&type=chunk) [13. Commitments and Contingencies](index=27&type=section&id=13.%20Commitments%20and%20Contingencies) The company is involved in legal proceedings and has indemnification accruals of $3.2 million, but management does not anticipate a material adverse effect - The company is involved in ongoing legal proceedings, including a derivative shareholder action and a lawsuit related to disclosures about the MBP program[123](index=123&type=chunk) - Indemnification accruals of **$3.21 million** were recorded as of June 30, 2025, related to the sale of its wholly-owned subsidiary, Trans Ova[125](index=125&type=chunk) - Management does not believe that any current legal 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[126](index=126&type=chunk) [14. Segments](index=28&type=section&id=14.%20Segments) In Q1 2025, Precigen realigned its operations into a single segment, focusing on core therapeutic areas and using net loss to assess performance and allocate resources - In the first quarter of 2025, the company realigned its former two operating segments (Biopharmaceuticals and Exemplar) into one operating segment, focusing on developing and commercializing product candidates in immuno-oncology, autoimmune disorders, and infectious diseases[127](index=127&type=chunk) - The Chief Operating Decision Maker (CEO) now uses net loss to assess performance and allocate resources at a consolidated level[128](index=128&type=chunk) - Substantially all of the company's long-lived assets were held in the United States, with **no revenues derived from foreign countries** for any periods presented[129](index=129&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Precigen's financial condition and results of operations, detailing its strategic shift, financial challenges, and capital requirements [Overview](index=29&type=section&id=Overview) Precigen is a clinical-stage biopharmaceutical company focused on gene and cell therapies, strategically prioritizing PRGN-2012 and pausing other UltraCAR-T trials - Precigen is a discovery and clinical-stage biopharmaceutical company advancing gene and cell therapies, leveraging proprietary technology platforms including UltraCAR-T, AdenoVerse immunotherapy, and ActoBiotics[134](index=134&type=chunk)[135](index=135&type=chunk) - In August 2024, the company announced a strategic prioritization of its pipeline to focus on the development of its lead program, PRGN-2012, for recurrent respiratory papillomatosis (RRP)[137](index=137&type=chunk)[138](index=138&type=chunk) - This prioritization included pausing enrollment in PRGN-3005 and PRGN-3007 UltraCAR-T clinical trials, minimizing UltraCAR-T spending, and completing the shutdown of the ActoBio subsidiary operations[137](index=137&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - The Biologics License Application (BLA) for PRGN-2012 has been submitted and granted priority review by the FDA, with a PDUFA target action date set for August 27, 2025[138](index=138&type=chunk)[140](index=140&type=chunk) [Financial overview](index=31&type=section&id=Financial%20overview) Precigen has incurred significant losses with an accumulated deficit of $2.2 billion, and future profitability depends on successful product development and commercialization, especially PRGN-2012 - The company has incurred significant losses since its inception, with an accumulated deficit of **$2.2 billion** as of June 30, 2025, and expects to continue incurring significant losses in the foreseeable future[149](index=149&type=chunk)[176](index=176&type=chunk) - Transition to profitability depends on the successful development, approval, and commercialization of product candidates, and achieving sufficient revenues to support the cost structure[45](index=45&type=chunk)[149](index=149&type=chunk) - Future revenues will primarily depend on the ability to advance proprietary programs and bring products, especially PRGN-2012, to market, with historical collaboration revenues expected to be minimal[154](index=154&type=chunk) [Sources of revenue](index=32&type=section&id=Sources%20of%20revenue) Precigen's primary revenues are from its Exemplar subsidiary's genetically engineered miniature swine models, with future growth dependent on proprietary product commercialization - Primary revenues currently arise from Exemplar, which generates product and service revenues through the development and sale of genetically engineered miniature swine models[153](index=153&type=chunk) - Future revenues will primarily depend on the company's ability to advance and commercialize its own programs and products, with collaboration revenues expected to be **minimal or zero in the near term**, unless new strategic transactions are entered into[154](index=154&type=chunk) [Cost of products and services](index=32&type=section&id=Cost%20of%20products%20and%20services) Costs of products and services, primarily from the Exemplar segment, slightly increased due to higher revenues, encompassing labor, supplies, feed, and facility charges - Cost of products and services, all related to the Exemplar reporting segment, slightly increased primarily as a result of higher revenues at Exemplar[155](index=155&type=chunk)[164](index=164&type=chunk)[171](index=171&type=chunk) - These costs primarily include labor, drugs and supplies, feed used in production, and facility charges, with **no significant impact from fluctuations in the price of livestock and feed on operating margins**[155](index=155&type=chunk) [Research and development expenses](index=32&type=section&id=Research%20and%20development%20expenses) Research and development expenses decreased significantly by 27% for both the three and six months ended June 30, 2025, primarily due to ActoBio closure and reduced CRO costs, reflecting strategic prioritization | Research and Development Expenses (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $11.49 | $15.69 | $21.97 | $29.94 | | **Change** | **$(4.21)** | **(26.8%)** | **$(7.98)** | **(26.6%)** | - The decrease in R&D expenses was primarily due to a **$3.80 million** (Q2) and **$5.60 million** (YTD) decrease in costs associated with ActoBio operations after its closure in late 2024, and a **$0.50 million** (Q2) and **$1.50 million** (YTD) decrease at contract research organizations due to asset prioritization[165](index=165&type=chunk)[172](index=172&type=chunk) [Selling, general and administrative expenses](index=33&type=section&id=Selling%2C%20general%20and%20administrative%20expenses) Selling, general and administrative expenses increased significantly by 57% for Q2 2025 and 39% for YTD 2025, driven by PRGN-2012 commercial readiness efforts | SG&A Expenses (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative | $16.13 | $10.31 | $28.49 | $20.46 | | **Change** | **$5.83** | **56.5%** | **$8.04** | **39.3%** | - The increase in SG&A expenses was primarily associated with PRGN-2012 commercial readiness efforts[166](index=166&type=chunk)[173](index=173&type=chunk) [Other income (expense), net](index=33&type=section&id=Other%20income%20%28expense%29%2C%20net) Total other income (expense), net, showed a significant increase in income for Q2 2025 due to decreased warrant liabilities fair value, but a substantial expense for YTD 2025 due to increased fair value | Other Income (Expense), Net (in millions) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total other income (expense), net | $5.12 | $0.36 | $(26.43) | $1.00 | | **Change** | **$4.76** | **>200%** | **$(27.43)** | **>(200%)** | - The change was primarily driven by a **$4.50 million** decrease in the fair value of warrant liabilities for Q2 2025, influenced by a decrease in stock price, and a **$28.00 million** increase in the fair value of warrant liabilities for YTD 2025, influenced by an increase in stock price since December 31, 2024[168](index=168&type=chunk)[175](index=175&type=chunk) [Results of operations](index=33&type=section&id=Results%20of%20operations) This section provides a detailed comparative analysis of the company's financial performance, highlighting changes in revenues, operating expenses, and net loss for the reported periods [Comparison of the three months ended June 30, 2025 and the three months ended June 30, 2024](index=33&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030%2C%202025%20and%20the%20three%20months%20ended%20June%2030%2C%202024) For Q2 2025, total revenues increased by 19.4%, while total operating expenses decreased by 47.0% due to significantly lower impairment charges, resulting in a 54.7% reduction in net loss | Metric (in millions) | June 30, 2025 | June 30, 2024 | Dollar Change | Percent Change | | :-------------------- | :------------ | :------------ | :------------ | :------------- | | Product revenues | $0.04 | $0.03 | $0.01 | **32.3%** | | Service revenues | $0.78 | $0.67 | $0.11 | **16.0%** | | Other revenues | $0.03 | $0.01 | $0.02 | **161.5%** | | Total revenues | $0.86 | $0.72 | $0.14 | **19.4%** | | Cost of product and services | $1.09 | $1.01 | $0.08 | **7.7%** | | Research and development | $11.49 | $15.69 | $(4.21) | **(26.8%)** | | Selling, general and administrative | $16.13 | $10.31 | $5.83 | **56.5%** | | Impairment of goodwill | $3.91 | $1.63 | $2.28 | **139.7%** | | Impairment of other noncurrent assets | $— | $32.92 | $(32.92) | **(100.0%)** | | Total operating expenses | $32.62 | $61.56 | $(28.94) | **(47.0%)** | | Operating loss | $(31.76) | $(60.84) | $29.08 | **(47.8%)** | | Total other income (expense), net | $5.12 | $0.36 | $4.76 | **>200%** | | Loss before income taxes | $(26.64) | $(60.48) | $33.84 | **(56.0%)** | | Income tax (expense) benefit | $(0.00) | $1.69 | $(1.69) | **(100.2%)** | | Net loss | $(26.64) | $(58.79) | $32.15 | **(54.7%)** | [Comparison of the six months ended June 30, 2025 and the six months ended June 30, 2024](index=36&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030%2C%202025%20and%20the%20six%20months%20ended%20June%2030%2C%202024) For YTD 2025, total revenues increased by 23.3%, and total operating expenses decreased by 35.0% due to lower impairment charges, leading to a 2.1% reduction in net loss | Metric (in millions) | June 30, 2025 | June 30, 2024 | Dollar Change | Percent Change | | :-------------------- | :------------ | :------------ | :------------ | :------------- | | Product revenues | $0.24 | $0.17 | $0.08 | **44.4%** | | Service revenues | $1.90 | $1.59 | $0.30 | **19.1%** | | Other revenues | $0.06 | $0.02 | $0.04 | **171.4%** | | Total revenues | $2.20 | $1.78 | $0.42 | **23.3%** | | Cost of product and services | $2.19 | $2.09 | $0.10 | **4.9%** | | Research and development | $21.97 | $29.94 | $(7.98) | **(26.6%)** | | Selling, general and administrative | $28.49 | $20.46 | $8.04 | **39.3%** | | Impairment of goodwill | $3.91 | $1.63 | $2.28 | **139.7%** | | Impairment of other noncurrent assets | $— | $32.92 | $(32.92) | **(100.0%)** | | Total operating expenses | $56.56 | $87.03 | $(30.48) | **(35.0%)** | | Operating loss | $(54.36) | $(85.25) | $30.89 | **(36.2%)** | | Total other income (expense), net | $(26.43) | $1.00 | $(27.43) | **>(200%)** | | Loss before income taxes | $(80.79) | $(84.25) | $3.46 | **(4.1%)** | | Income tax (expense) benefit | $(0.00) | $1.72 | $(1.72) | **(100.2%)** | | Net loss | $(80.80) | $(82.53) | $1.73 | **(2.1%)** | [Liquidity and capital resources](index=37&type=section&id=Liquidity%20and%20capital%20resources) Precigen has an accumulated deficit of $2.2 billion and faces substantial doubt about its ability to continue as a going concern, relying on future capital raises and PRGN-2012 commercialization [Sources of liquidity](index=37&type=section&id=Sources%20of%20liquidity) Precigen historically funded operations through equity, debt, and collaborations, holding $13.8 million in cash and $46.0 million in investments as of June 30, 2025 - As of June 30, 2025, the company had an accumulated deficit of **$2.2 billion**[176](index=176&type=chunk) | Metric (in millions) | June 30, 2025 | | :-------------------- | :------------ | | Cash and cash equivalents | $13.80 | | Investments | $46.00 | - Recent financing includes **$30.9 million** net proceeds from an August 2024 public offering of common stock and **$78.5 million** net proceeds from a December 2024 issuance of Series A Preferred Stock and warrants[177](index=177&type=chunk)[178](index=178&type=chunk) [Cash flows](index=37&type=section&id=Cash%20flows) For YTD 2025, operating activities used $35.3 million in cash, investing activities provided $22.0 million, and financing activities used $2.4 million, resulting in a net decrease of $15.8 million in cash | Cash Flow Activity (in millions) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(35.30) | $(37.20) | | Net cash provided by investing activities | $21.98 | $39.00 | | Net cash (used in) provided by financing activities | $(2.44) | $0.05 | | Effect of exchange rate changes | $0.01 | $(0.10) | | Net (decrease) increase in cash | $(15.76) | $1.76 | - Significant noncash expenses for the six months ended June 30, 2025, included **$28.0 million** unrealized appreciation in warrant liabilities, **$3.9 million** goodwill impairment, and **$4.3 million** stock-based compensation[180](index=180&type=chunk) [Future Capital Requirements](index=38&type=section&id=Future%20capital%20requirements) Precigen's future capital requirements depend on R&D progress and commercialization efforts, facing substantial doubt about going concern and needing additional capital through various means - The company's ability to continue as a going concern is dependent upon the successful execution of management's plans, including the successful commercialization of PRGN-2012, and the receipt of future payments dependent on FDA approval[191](index=191&type=chunk)[192](index=192&type=chunk) - Future capital requirements depend on factors such as R&D programs, manufacturing capabilities, commercial operations, regulatory approvals, and legal activities[186](index=186&type=chunk)[187](index=187&type=chunk) - Additional capital may be raised through equity offerings, debt financings, strategic alliances, asset sales, or licensing arrangements, which could result in dilution to common shareholders or relinquishing valuable rights[186](index=186&type=chunk)[188](index=188&type=chunk)[192](index=192&type=chunk) [Contractual obligations and commitments](index=40&type=section&id=Contractual%20obligations%20and%20commitments) Precigen's significant contractual obligations include $6.7 million in operating leases and $4.6 million in R&D commitments, with potential future milestone and royalty payments | Contractual Obligation (in millions) | Total | Less Than 1 Year | 1 - 3 Years | 3 - 5 Years | More Than 5 Years | | :------------------------------------ | :---- | :--------------- | :---------- | :---------- | :---------------- | | Operating leases | $6.75 | $1.49 | $2.78 | $2.48 | $— | - As of June 30, 2025, the company had research and development commitments with third parties totaling **$4.6 million** that had not yet been incurred[194](index=194&type=chunk) [Off-balance sheet arrangements](index=40&type=section&id=Off-balance%20sheet%20arrangements) Precigen did not have any off-balance sheet arrangements during the periods presented - The company did not have, and does not currently have, any **off-balance sheet arrangements** as defined under SEC rules during the periods presented[195](index=195&type=chunk) [Critical accounting policies and estimates](index=40&type=section&id=Critical%20accounting%20policies%20and%20estimates) There have been no material changes to the company's critical accounting policies from those described in its Annual Report on Form 10-K - There have been **no material changes** to the company's critical accounting policies from those described in 'Management's Discussion and Analysis of Financial Condition and Results of Operations' included in its Annual Report[197](index=197&type=chunk) [Recent accounting pronouncements](index=40&type=section&id=Recent%20accounting%20pronouncements) Information regarding recent accounting pronouncements and their impact is provided in Note 2 to the financial statements - For information with respect to recent accounting pronouncements and their impact, refer to 'Notes to the Condensed Consolidated Financial Statements (Unaudited) - Note 2'[198](index=198&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Precigen's primary market risk exposure is to interest rate fluctuations on its cash, cash equivalents, and investments, with no material impact expected from a 100 basis point increase | Metric (in millions) | June 30, 2025 | December 31, 2024 | | :------------------- | :------------ | :---------------- | | Cash, cash equivalents and short-term and long-term investments | $59.8 | $97.9 | - A hypothetical **100 basis point** increase in interest rates would **not materially affect** the fair value of the company's interest-sensitive financial instruments[201](index=201&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded Precigen's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level** as of June 30, 2025[202](index=202&type=chunk) - There has been **no change in internal control over financial reporting** during the three months ended June 30, 2025, that has materially affected, or is reasonably likely to materially affect, internal control over financial reporting[203](index=203&type=chunk) [PART II - OTHER INFORMATION](index=42&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section provides information on legal proceedings, risk factors, equity sales, defaults, mine safety, other disclosures, and exhibits [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) Precigen is involved in various legal matters, including governmental investigations and shareholder actions, but does not anticipate a material adverse effect on its financial condition - The company is involved in litigation or legal matters, including governmental investigations, but does not believe any will have a **material adverse effect** on its business, financial condition, results of operations, or cash flows as of June 30, 2025[206](index=206&type=chunk) - Further discussion of ongoing legal matters is provided in Note 13 to the Condensed Consolidated Financial Statements[207](index=207&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) There are no additional material updates or changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - There are **no additional material updates or changes** to the risk factors since the filing of the Annual Report on Form 10-K for the year ended December 31, 2024[208](index=208&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds for the period - **None**[210](index=210&type=chunk) [Item 3. Defaults on Senior Securities](index=42&type=section&id=Item%203.%20Defaults%20on%20Senior%20Securities) The company reported no defaults on senior securities for the period - **None**[211](index=211&type=chunk) [Item 4. Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Precigen, Inc. - **Not applicable**[212](index=212&type=chunk) [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - **None**[213](index=213&type=chunk) [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including amendments to the articles of incorporation, CEO/CFO certifications, and the Interactive Data File - Exhibits include Articles of Amendment to the Amended and Restated Articles of Incorporation, certifications from the CEO and CFO (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act), and the Interactive Data File (XBRL) for the financial statements[214](index=214&type=chunk) [Signatures](index=44&type=section&id=Signatures) The Form 10-Q is duly signed on behalf of Precigen, Inc. by its Chief Financial Officer, Harry Thomasian Jr., on August 12, 2025 - The report was signed by Harry Thomasian Jr., Chief Financial Officer (Principal Financial and Accounting Officer) of Precigen, Inc., on August 12, 2025[219](index=219&type=chunk)
Precigen: August Is Pivotal For This Biotech Innovator
Seeking Alpha· 2025-07-07 21:58
Core Viewpoint - The stock price of Precigen (NASDAQ: PGEN) has remained unchanged at $1.62 over a period of 17 months, indicating a lack of significant movement or development in the company's valuation [1]. Company Analysis - Precigen was rated a HOLD on January 31, 2023, at a price of $1.62, and as of July 3, 2025, the stock price is still $1.62, suggesting stability but potentially stagnation in growth or investor interest [1]. Analyst Background - The analyst has a background in finance, teaching international finance and financial risk management, and has experience in various sectors including biotech and fintech [2].
Precigen(PGEN) - 2025 Q1 - Quarterly Report
2025-05-14 20:23
```markdown PART I - FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents unaudited condensed financial statements for Q1 2025 and 2024, detailing increased net loss, a shift to shareholders' deficit, and a going concern disclosure [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Precigen's balance sheet as of March 31, 2025, reflects decreased assets, increased liabilities from warrant revaluation, and a shift to a shareholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $6,058 | $29,517 | ($23,459) | | Short-term investments | $74,184 | $68,393 | $5,791 | | **Total Assets** | **$128,787** | **$145,266** | **($16,479)** | | Warrant liabilities | $83,018 | $50,537 | $32,481 | | **Total Liabilities** | **$113,329** | **$78,535** | **$34,794** | | **Total Shareholders' (Deficit) Equity** | **($14,060)** | **$38,513** | **($52,573)** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2025 operations show increased revenues and narrowed operating loss, but a significant non-cash warrant liability expense resulted in a substantial net loss increase Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenues | $1,341 | $1,065 | | Research and development | $10,478 | $14,249 | | Selling, general and administrative | $12,359 | $10,151 | | Operating loss | ($22,596) | ($24,410) | | Change in fair value of warrant liabilities | ($32,481) | $0 | | **Net loss** | **($54,153)** | **($23,738)** | | **Net loss per share, basic and diluted** | **($0.18)** | **($0.10)** | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2025 cash flows indicate increased cash used in operations and a reversal in investing activities, leading to a significant overall decrease in cash and cash equivalents Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,325) | ($14,090) | | Net cash (used in) provided by investing activities | ($6,457) | $24,045 | | Net cash used in financing activities | ($679) | $0 | | **Net (decrease) increase in cash** | **($23,459)** | **$9,895** | [Notes to the Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, PRGN-2012's PDUFA date, substantial doubt about going concern, warrant liability re-measurement, and segment realignment - The company's lead product candidate, **PRGN-2012**, has been granted **priority review** by the FDA with a PDUFA target action date of **August 27, 2025**[35](index=35&type=chunk) - Management has concluded there is **substantial doubt about the Company's ability to continue as a going concern**, as its current cash and investments are **not sufficient to fund planned operations for one year**. This analysis excludes potential revenue from PRGN-2012, which is not yet approved[42](index=42&type=chunk)[44](index=44&type=chunk) - The company recorded a **$32.5 million expense** due to the **change in fair value of warrant liabilities**, driven by an increase in the company's stock price and other factors[80](index=80&type=chunk) - Effective Q1 2025, the company realigned its operations into a **single operating segment** to streamline operations and focus on the potential commercial launch of PRGN-2012[123](index=123&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to prioritize PRGN-2012, detailing Q1 2025 financial results, including R&D and SG&A changes, warrant liability impact, and reiterating the going concern issue [Overview](index=27&type=section&id=Overview) Precigen, a clinical-stage biopharmaceutical company, strategically prioritized its pipeline on PRGN-2012 for RRP, which received FDA priority review with an August 2025 PDUFA date, while pausing other clinical trials - The company has **strategically prioritized** its pipeline to focus resources on the potential commercialization of its lead program, **PRGN-2012**[133](index=133&type=chunk) - The FDA granted **priority review** to the **PRGN-2012 Biologics License Application (BLA)** for RRP, with a PDUFA target action date of **August 27, 2025**[134](index=134&type=chunk)[137](index=137&type=chunk) - As part of the restructuring, enrollment has been **paused** for the **PRGN-3005 and PRGN-3007 UltraCAR-T clinical trials** to minimize spending and focus on partnerships[132](index=132&type=chunk)[133](index=133&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20operations) Q1 2025 results show a 26% revenue increase, a 27% decrease in R&D expenses, a 22% increase in SG&A expenses, and a significant net loss increase due to a non-cash warrant liability charge Comparison of Operations for the Three Months Ended March 31 (in thousands) | Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $1,341 | $1,065 | $276 | 25.9% | | Research and development | $10,478 | $14,249 | ($3,771) | (26.5)% | | Selling, general and administrative | $12,359 | $10,151 | $2,208 | 21.8% | | Operating loss | ($22,596) | ($24,410) | $1,814 | (7.4)% | | Net loss | ($54,153) | ($23,738) | ($30,415) | 128.1% | - R&D expenses **decreased by $3.8 million**, mainly due to the **closure of ActoBio operations** and **reduced headcount** following the 2024 strategic prioritization[161](index=161&type=chunk) - SG&A expenses **increased by $2.2 million**, primarily driven by costs for **PRGN-2012 commercial readiness**[162](index=162&type=chunk) - The **significant increase in net loss** was primarily caused by a **non-cash charge of $32.5 million** for the **change in fair value of warrant liabilities**, influenced by an increase in the company's stock price[163](index=163&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20capital%20resources) As of March 31, 2025, the company had $81.0 million in cash and investments, but despite recent capital raises, management concluded existing funds are insufficient for one year, raising substantial doubt about its going concern ability - As of March 31, 2025, the company had **$6.1 million** in cash and cash equivalents and **$74.9 million** in investments[164](index=164&type=chunk) - Recent financing includes a public offering in August 2024 (net proceeds **$30.9M**) and a private placement of preferred stock and warrants in December 2024 (net proceeds **~$78.5M**)[165](index=165&type=chunk)[166](index=166&type=chunk) - Management states that current cash projections, excluding potential but uncertain revenue from PRGN-2012, are **not sufficient to fund operations for at least one year**, which raises **substantial doubt about the company's ability to continue as a going concern**[176](index=176&type=chunk) - Future capital needs will be financed through a combination of **equity/debt offerings, strategic alliances, and potential product revenue**. The ability to continue as a going concern depends on **successfully commercializing PRGN-2012 or raising additional capital**[173](index=173&type=chunk)[177](index=177&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate risk on its $81.0 million in cash and investments, with management believing a 100 basis point rate increase would not materially affect fair value - The company's market risk is primarily related to **interest rate fluctuations** on its **$81.0 million** of cash, cash equivalents, and investments[186](index=186&type=chunk) - Management believes a hypothetical **100 basis point change** in interest rates would **not have a material effect** on the fair value of its financial instruments[186](index=186&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2025, the CEO and CFO concluded that disclosure controls and procedures are effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[187](index=187&type=chunk) - **No material changes** to the company's internal control over financial reporting occurred during the first quarter of 2025[188](index=188&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal matters, including a derivative shareholder action, but does not anticipate a material adverse effect, with a $3.2 million indemnification accrual remaining - The company is involved in a **derivative shareholder action** (Wright v. Alvarez et al.) and a **shareholder lawsuit** demanding inspection of books and records (Kent v. Precigen, Inc.), both related to historical disclosures[119](index=119&type=chunk) - As of March 31, 2025, an **indemnification accrual of $3.213 million** remains related to the sale of Trans Ova[121](index=121&type=chunk) - Management does **not currently believe** that ongoing legal matters will have a **material adverse effect** on the company's financial condition or operations[191](index=191&type=chunk) [Risk Factors](index=37&type=page&id=Item%201A.%20Risk%20Factors) No material updates or changes to the company's risk factors have occurred since the filing of its Annual Report on Form 10-K for the year ended December 31, 2024 - **No material updates or changes** to the company's risk factors have occurred since the filing of the Annual Report for the year ended December 31, 2024[193](index=193&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) None - **None**[195](index=195&type=chunk) [Defaults on Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20on%20Senior%20Securities) None - **None**[196](index=196&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - **Not applicable**[197](index=197&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) None - **None**[198](index=198&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications required by the Sarbanes-Oxley Act and the Interactive Data File (XBRL) - Exhibits include **CEO and CFO certifications** pursuant to **Sarbanes-Oxley Act Sections 302 and 906**[199](index=199&type=chunk) ```
Precigen(PGEN) - 2025 Q1 - Quarterly Results
2025-05-14 20:19
[Business and Financial Highlights](index=1&type=section&id=Business%20and%20Financial%20Highlights) Precigen advanced PRGN-2012 for RRP with FDA priority review (PDUFA August 2025), ending Q1 2025 with $81 million cash, funding operations into 2026 - The company is highly focused on advancing PRGN-2012, which could become the first FDA-approved therapeutic for RRP, with a PDUFA target action date of **August 27, 2025**[3](index=3&type=chunk)[6](index=6&type=chunk) - Precigen and the Recurrent Respiratory Papillomatosis Foundation will host the 2025 International RRP Awareness Day on June 11 to engage with patients, caregivers, and the healthcare community[3](index=3&type=chunk)[4](index=4&type=chunk) Financial Position | Financial Position | Amount ($) | Note | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $81.0 million | As of March 31, 2025 | | Cash Runway Expectation | Into 2026 | Excludes potential PRGN-2012 revenue | [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Precigen's clinical pipeline is led by PRGN-2012 nearing FDA approval, with other candidates like PRGN-2009 and PRGN-3006 also advancing [PRGN-2012 AdenoVerse Gene Therapy in RRP](index=1&type=section&id=PRGN-2012%20AdenoVerse%20Gene%20Therapy%20in%20RRP) PRGN-2012, an RRP gene therapy, is under FDA priority review (PDUFA August 2025), showing 51% complete response in pivotal study, with 2025 commercial launch preparations underway - The FDA accepted the BLA for PRGN-2012, granted priority review, and set a PDUFA target action date for **August 27, 2025** An advisory committee meeting is not currently planned[6](index=6&type=chunk)[7](index=7&type=chunk) - Pivotal study results showed **51%** of patients (18 of 35) achieved a Complete Response, requiring no surgeries after treatment, with durable responses observed for up to three years[7](index=7&type=chunk)[8](index=8&type=chunk) - **86%** of patients (30 of 35) experienced a decrease in surgical interventions post-treatment, with median surgeries dropping from 4 to 0[15](index=15&type=chunk) - Commercial and manufacturing readiness campaigns are advancing in anticipation of a potential **2025** launch, supported by commercialization partner EVERSANA[6](index=6&type=chunk)[15](index=15&type=chunk) [PRGN-2009 AdenoVerse Gene Therapy in HPV-associated Cancers](index=3&type=section&id=PRGN-2009%20AdenoVerse%20Gene%20Therapy%20in%20HPV-associated%20Cancers) PRGN-2009, an investigational gene therapy for HPV-associated cancers, is undergoing Phase 2 clinical trials in partnership with the NCI - Phase 2 clinical trials are ongoing for recurrent/metastatic cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer in partnership with the NCI[9](index=9&type=chunk) [PRGN-3006 UltraCAR-T in AML and MDS](index=3&type=section&id=PRGN-3006%20UltraCAR-T%20in%20AML%20and%20MDS) PRGN-3006, an autologous CAR-T therapy for AML and MDS, has completed Phase 1b enrollment for AML and received FDA Orphan Drug and Fast Track designations - The company has completed patient enrollment in the Phase 1b trial for PRGN-3006 in AML[10](index=10&type=chunk) - PRGN-3006 has been granted Orphan Drug Designation for AML and Fast Track Designation for relapsed/refractory (r/r) AML by the FDA[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) Precigen's Q1 2025 revenues rose 26% to $1.3 million, while R&D decreased 27% and SG&A increased 22%, resulting in a $54.2 million net loss primarily due to warrant liabilities Financial Performance Summary | Metric | Q1 2025 ($) | Q1 2024 ($) | Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $1.3M | $1.1M | +26% | Increased volume at Exemplar | | R&D Expenses | $10.5M | $14.2M | -27% | Closure of ActoBio operations and asset prioritization | | SG&A Expenses | $12.4M | $10.2M | +22% | PRGN-2012 commercial readiness activities | | Net Loss | $54.2M | $23.7M | +129% | Primarily a $32.5M non-cash change in fair value of warrant liabilities | | Net Loss Per Share | $(0.18) | $(0.10) | +80% | Increased net loss and higher share count | - Total other expense was **$31.6 million**, a significant shift from an income of **$0.6 million** in Q1 2024 This was driven by a **$32.5 million** non-cash increase in the fair value of warrant liabilities due to a higher stock price[14](index=14&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) Precigen's unaudited consolidated financial statements for Q1 2025 show total assets of $128.8 million, total liabilities of $113.3 million, and a net loss of $54.2 million [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Precigen's balance sheet as of March 31, 2025, shows total assets of $128.8 million and total liabilities of $113.3 million, driven by increased warrant liabilities Balance Sheet Summary | (Amounts in thousands) | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $6,058 | $29,517 | | Short-term investments | $74,184 | $68,393 | | **Total Assets** | **$128,787** | **$145,266** | | **Liabilities & Equity** | | | | Warrant liabilities | $83,018 | $50,537 | | **Total Liabilities** | **$113,329** | **$78,535** | | Total shareholders' (deficit) equity | $(14,060) | $38,513 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Precigen's Q1 2025 statement of operations shows $1.34 million in revenues, a $22.6 million operating loss, and a $54.2 million net loss due to warrant liabilities Statements of Operations Summary | (Amounts in thousands, except per share data) | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Total revenues | $1,341 | $1,065 | | Total operating expenses | $23,937 | $25,475 | | Operating loss | $(22,596) | $(24,410) | | Change in fair value of warrant liabilities | $(32,481) | $— | | **Net loss** | **$(54,153)** | **$(23,738)** | | Net loss per share, basic and diluted | $(0.18) | $(0.10) |
Precigen and Recurrent Respiratory Papillomatosis Foundation to Host the 2025 International RRP Awareness Day on June 11th
Prnewswire· 2025-04-16 12:05
Core Insights - Precigen, Inc. is collaborating with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to co-host the annual RRP Awareness Day on June 11, 2025, aimed at raising awareness about recurrent respiratory papillomatosis (RRP) and fostering community among patients, caregivers, and healthcare professionals [1][3] Company Overview - Precigen, Inc. is a biopharmaceutical company focused on developing innovative gene and cell therapies to improve patient lives, particularly in the areas of immuno-oncology, autoimmune disorders, and infectious diseases [6] - The company operates as an innovation engine, progressing a pipeline of therapies toward clinical proof-of-concept and commercialization [6] Industry Context - RRP is a rare, chronic disease primarily caused by HPV 6/11 infection, affecting approximately 27,000 adults in the US and over 125,000 patients globally [2] - The current standard-of-care for RRP involves repeated surgeries, which do not address the underlying cause and carry significant risks, including the potential for irreversible injury [2][4] - There is a high unmet need for effective treatment options that can address the root cause of RRP and reduce the frequency of surgeries [2][4] Event Details - RRP Awareness Day will feature a live event in Washington DC, including a panel discussion with patients, caregivers, and physicians, and will be broadcast globally [3] - The event aims to highlight the experiences of those living with RRP and the urgent need for new treatment options [3][4] Organizational Goals - The RRPF aims to provide support for families, promote public awareness, and stimulate research for more effective treatments and potential cures for RRP [7] - The organization focuses on networking within the RRP community, including patients, families, medical practitioners, and researchers [7]