Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive an ...

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company reported a significant increase in revenue, with a year-over-year growth of 15%, reaching $1.5 billion in the last quarter [2] - Operating income also saw a rise, up by 10% to $300 million, indicating improved operational efficiency [2] Market Position - The company has strengthened its market share, now holding 25% of the industry, which reflects a competitive advantage over its peers [2] - Recent strategic partnerships have been established, aimed at expanding the company's reach into emerging markets [2] Future Outlook - Analysts predict continued growth for the company, with expectations of a 12% increase in revenue for the next fiscal year [2] - The company is investing in technology and innovation, which is expected to enhance its product offerings and customer engagement [2]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $123.6 million in cash, cash equivalents, and investments, following a drawdown of the first tranche of its credit facility [16] - The company ended the quarter with approximately $3 million in inventory, representing manufacturing costs incurred post-approval of PAPZIMEOS [17] - The net loss attributable to common shareholders for the quarter was $1.06 per share, which included two large non-cash accounting items totaling $0.95 per share [18] Business Line Data and Key Metrics Changes - PAPZIMEOS was granted full FDA approval in August 2025, marking a significant milestone for the company and the treatment of recurrent respiratory papillomatosis (RRP) [5][6] - The drug has shown a 51% complete response rate, with 86% of patients experiencing a reduction in surgical burden after treatment [3][4] Market Data and Key Metrics Changes - The company has engaged with 90% of target institutions covering a significant portion of the estimated 27,000 adult patients with RRP in the U.S. [9] - Over 80 million lives are covered under payer policies for PAPZIMEOS, including Medicare and Medicaid [10] Company Strategy and Development Direction - The company aims to establish PAPZIMEOS as the new standard of care for adults with RRP, with ongoing efforts for geographic expansion and pediatric clinical trials [7][12] - The company has made significant investments in in-house CGMP manufacturing operations to ensure control over production and meet anticipated demand [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in reaching cash flow breakeven by the end of 2026, supported by projected revenues from PAPZIMEOS [17][31] - The management highlighted the strong pent-up demand for PAPZIMEOS, with expectations for continued patient enrollment and treatment initiation [35][46] Other Important Information - The company has implemented a new ERP system to support its commercial operations and manage processes effectively [19] - The pivotal study for PAPZIMEOS is noted as the first and only clinical trial in RRP with a robust statistical primary endpoint [4] Q&A Session Summary Question: Any updates on patient reimbursement approvals or dosing? - The company has started shipping PAPZIMEOS to institutions, and payer coverage is progressing well, with expectations for patient dosing to increase in Q4 [22][24] Question: What assumptions are made regarding cash flow breakeven? - The company is not providing specific revenue guidance but expects to reach cash flow breakeven by the end of 2026 [30][31] Question: How long is the expected bolus of patients for therapy? - The company anticipates a prolonged bolus of patients due to the existing demand and the broad label for PAPZIMEOS, which includes all adult RRP patients [34][36] Question: How is revenue recognized for PAPZIMEOS? - Revenue is recognized upon transfer of title when the drug is shipped to healthcare entities, not upon patient injection [43][44] Question: Will all registered patients receive PAPZIMEOS? - The company expects a high percentage of registered patients to ultimately receive treatment, with a sense of urgency from the physician community [45][46]

Financial Performance - Total revenues for the three months ended September 30, 2025, were $2,922,000, a significant increase from $953,000 in the same period of 2024, representing a growth of 206%[23] - The company reported a net loss of $146,344,000 for the three months ended September 30, 2025, compared to a net loss of $23,978,000 for the same period in 2024, indicating a substantial increase in losses[23] - For the nine months ended September 30, 2025, the company reported a net loss of $227,139,000, compared to a net loss of $106,508,000 for the same period in 2024, representing an increase in loss of approximately 113%[38] - The company experienced a net loss of $23,978,000 for the quarter ending September 30, 2024, compared to a net loss of $106,508,000 for the previous quarter, indicating a significant reduction in losses[33] - Net loss attributable to common shareholders reached $325.3 million, compared to $24.0 million in the same period last year, reflecting an increase of less than 200%[191] - Net loss per share attributable to common shareholders increased to $1.06 from $0.09, primarily due to changes in fair value of warrant liabilities and a deemed dividend[198] Revenue Sources - The company reported collaboration and licensing revenue of $1,818,000 for the three months ended September 30, 2025, compared to no revenue in the same period of 2024[23] - Total revenues increased by $2.0 million, or over 200%, primarily driven by collaboration and licensing revenues, with $1.8 million recognized from a terminated agreement[192] - Product revenues rose to $162,000, a 145.5% increase from $66,000 in the prior year[191] - Service revenues increased by 6.3%, reaching $942,000 compared to $886,000 in the previous year[191] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2025, were $34,343,000, down from $41,312,000 in the same period of 2024, reflecting a decrease of 17%[23] - Selling, general and administrative expenses surged by $14.2 million, or 144%, driven by costs associated with Papzimeos commercial readiness[195] - Operating loss for the three months ended September 30, 2025, was $34.5 million, a 62.2% increase from $21.3 million in the prior year[191] - The company reported stock-based compensation of $2,061,000 for the quarter ending September 30, 2024, reflecting ongoing investment in employee incentives[30] - The company recognized a significant increase in stock-based compensation expense, which rose to $8,703,000 in 2025 from $6,606,000 in 2024, reflecting a 32% increase[38] Assets and Liabilities - Cash and cash equivalents decreased to $14,322,000 as of September 30, 2025, from $29,517,000 as of December 31, 2024, a decline of 51%[17] - Total assets increased to $171,264,000 as of September 30, 2025, compared to $145,266,000 as of December 31, 2024, representing a growth of 18%[19] - The company’s total liabilities rose to $129,396,000 as of September 30, 2025, up from $78,535,000 as of December 31, 2024, an increase of 65%[20] - The accumulated deficit increased to $(2,317,845,000) as of September 30, 2025, compared to $(2,090,706,000) as of December 31, 2024, indicating a worsening financial position[20] Stock and Equity - The weighted average shares outstanding for the three months ended September 30, 2025, were 307,170,490, compared to 275,881,170 for the same period in 2024, reflecting an increase in shares[23] - The total common stock shares outstanding increased to 292,869,097 as of September 30, 2024, up from 252,656,151 shares at June 30, 2024, representing a growth of approximately 15.9%[30] - Precigen, Inc. issued 39,878,939 shares in public offerings, net of issuance costs, contributing to the increase in total equity[33] - The company converted all holders of preferred stock to common stock in the third quarter of 2025, impacting the equity structure[75] Financing Activities - The company’s net cash provided by financing activities was $90,562,000 for the nine months ended September 30, 2025, compared to $32,179,000 for the same period in 2024, showing a substantial increase in financing[41] - The company entered into a Loan Agreement on September 3, 2025, securing a senior secured term loan facility of up to $125 million, with net proceeds of $92,818 after expenses[108] - The effective interest rate for the Term Loan was 12.5% for the three months ended September 30, 2025, with total interest expense of $902[112] Regulatory and Clinical Developments - The company received FDA approval for Papzimeos™ (Zopapogene Imadenovec) in August 2025, marking its transition from a development-stage to a commercial-stage company[44] - The FDA granted full approval of Papzimeos in August 2025, marking it as the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP)[167] - Papzimeos demonstrated a 51% complete response rate in a pivotal clinical trial, with 18 out of 35 patients requiring no surgeries in the 12 months post-treatment[169] - The FDA granted priority review for the company's BLA for PRGN-2012, with a target action date set for August 27, 2025[152] Strategic Initiatives - The company has initiated a strategic prioritization of its clinical portfolio, including a workforce reduction of over 20% to focus on the commercialization of Papzimeos[48] - The company is focusing on strategic partnerships to advance its UltraCAR-T programs, including PRGN-3006 in AML[173] - The proprietary UltraPorator device is designed to streamline and ensure rapid manufacturing of UltraCAR-T therapies, representing a significant advancement in the field[172] Other Financial Metrics - The company recorded a cumulative catch-up adjustment of $2,266 for stock-based compensation upon FDA approval of the BLA[140] - The total lease liabilities as of September 30, 2025, amounted to $5,302,000, with a current portion of $1,123,000[145] - The company had no outstanding balance on its $5 million revolving line of credit as of September 30, 2025, which bore interest at 8.00% per annum[114]

Financial Performance - Total revenues for Q3 2025 increased by $2.0 million compared to Q3 2024, primarily driven by collaboration and licensing revenue recognition[10] - Total revenues for the three months ended September 30, 2025, were $2.922 million, a significant increase from $953,000 in the same period of 2024, representing a growth of 206%[34] - Collaboration and licensing revenue reached $1.818 million in Q3 2025, compared to $0 in Q3 2024, indicating successful new partnerships[34] - Product revenues increased to $162,000 in Q3 2025 from $66,000 in Q3 2024, reflecting a growth of 145%[34] - Net loss attributable to common shareholders was $325.3 million, or $(1.06) per share, compared to a net loss of $24 million, or $(0.09) per share in Q3 2024[16] - Net loss attributable to common shareholders for Q3 2025 was $325.344 million, compared to $23.978 million in Q3 2024, primarily due to deemed dividends on preferred stock[34] - Operating loss for the nine months ended September 30, 2025, was $88.841 million, an improvement compared to a loss of $106.513 million in the same period of 2024[34] - The company reported a change in fair value of warrant liabilities of $(111.502) million for Q3 2025, which significantly impacted the overall financial results[34] Expenses - Research and development expenses rose by $1.0 million, or 9%, due to increased manufacturing and regulatory filing costs related to PAPZIMEOS[11] - Selling, General and Administrative (SG&A) expenses surged by $14.2 million, or 144%, mainly due to costs associated with PAPZIMEOS commercial readiness[12] - Research and development expenses for the nine months ended September 30, 2025, were $34.343 million, down from $41.312 million in the same period of 2024, indicating a reduction of 17%[34] Assets and Liabilities - Cash, cash equivalents, and investments totaled $123.6 million as of September 30, 2025, expected to fund operations to cash flow break-even[5] - Cash and cash equivalents decreased to $14.322 million as of September 30, 2025, down from $29.517 million at the end of 2024[32] - Total assets increased to $171.264 million as of September 30, 2025, compared to $145.266 million at the end of 2024, showing a growth of 18%[32] - Total current liabilities increased to $32.069 million as of September 30, 2025, compared to $21.518 million at the end of 2024, reflecting a rise of 49%[32] Product Development and Market Presence - Over 100 patients have been registered in the PAPZIMEOS Patient Hub since its launch, with more than 90% of target institutions engaged[5] - PAPZIMEOS received full FDA approval in August 2025, marking it as the first and only treatment for adults with recurrent respiratory papillomatosis (RRP)[6] - The company has achieved private health insurance coverage for over 100 million lives, with PAPZIMEOS now available through Medicare and Medicaid[7] - Long-term follow-up results from the pivotal clinical trial showed 83% of complete responders maintained their response without additional treatment interventions for a median of 36 months[14] - A Marketing Authorization Application for PAPZIMEOS was submitted to the European Medicines Agency in November 2025[7]

Core Insights - Precigen, Inc. announced third quarter 2025 financial results and business updates, highlighting the successful launch of PAPZIMEOS, the first FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP) [1][5][7]. Business Highlights - PAPZIMEOS received full FDA approval in August 2025, marking a significant advancement in treatment options for adults with RRP [6][7]. - The company has engaged over 90% of target institutions and registered over 100 patients in the PAPZIMEOS Patient Hub since the launch [2][6][7]. - Strong early interest and demand for PAPZIMEOS have been reported, with significant progress in private health insurance coverage, now covering over 100 million lives [5][6][7]. Financial Performance - Total revenues for Q3 2025 increased by $2.0 million compared to Q3 2024, primarily driven by collaboration and licensing revenue [8]. - Research and development expenses rose by $1.0 million, or 9%, due to increased manufacturing and regulatory costs related to PAPZIMEOS [9]. - Selling, General and Administrative (SG&A) expenses surged by $14.2 million, or 144%, largely due to costs associated with the commercialization of PAPZIMEOS [10]. - The company recorded a net loss attributable to common shareholders of $325.3 million for Q3 2025, significantly higher than the $24 million loss in Q3 2024, influenced by non-cash items [13][26]. Clinical and Market Developments - Long-term follow-up results from the pivotal clinical trial of PAPZIMEOS showed durable complete responses in 83% of patients after a median follow-up of 36 months [7]. - The company submitted a Marketing Authorization Application to the European Medicines Agency for PAPZIMEOS in November 2025, indicating plans for geographic expansion [6][7].

Core Insights - Patient Capital Management, LLC increased its position in Precigen by 10.2 million shares during Q3 2025, with an estimated transaction value of $28.78 million [1] - Precigen's stock price reached $4.01 as of October 29, 2025, reflecting a 375.91% increase over the past year, significantly outperforming the S&P 500 [2] - Precigen's market capitalization stands at $1.19 billion, with a trailing twelve months (TTM) revenue of $4.34 million and a net income loss of $124.50 million [3] Company Overview - Precigen specializes in gene and cellular therapies, disease-modifying therapeutics, and proprietary platforms such as UltraVector, Sleeping Beauty, UltraCAR-T, and AdenoVerse Immunotherapy [4][5] - The company operates a business model focused on research, development, and strategic collaborations within the biotechnology and healthcare sectors [4] Strategic Positioning - Precigen has a diversified technology portfolio and strategic collaborations that enable it to address complex medical needs in oncology and regenerative medicine [5] - The company’s competitive advantage lies in its proprietary platforms and partnerships that facilitate advancements in disease-modifying therapeutics [5] Recent Developments - Precigen's stock price surged after the FDA granted full approval to its drug Papzimeos, which treats recurrent respiratory papillomatosis (RRP), a condition affecting approximately 27,000 adults in the U.S. [7][8] - The addressable population for Papzimeos may grow as new patients seek treatment options for their debilitating conditions [8] Investment Insights - Precigen represents a significant holding for Patient Capital, accounting for 3.5% of its portfolio, up from just 1% at the end of the second quarter [6] - The stock has increased by 191.5% since June 30, 2025, indicating a strong performance for investors [7]

Fund Performance - The Patient Opportunity Equity Strategy achieved a total return of 14.1% net of fees in Q3 2025, outperforming the S&P 500 Index which returned 8.1% [2] - The portfolio's outperformance was driven by selection and interaction effects, while allocation effects partially offset these gains [3] Portfolio Composition - The strategy was overweight in sectors such as Consumer Discretionary, Communication Services, Financials, Energy, Industrials, and Health Care, while underweight in Real Estate, Utilities, Materials, Consumer Staples, and Information Technology [4] - The portfolio ended the quarter with 36 holdings, with the top 10 stocks representing 51.1% of total assets, indicating a high active share of approximately 92.5% [5] Market Context - The market's upward trend in Q3 was supported by resilient consumer spending, Federal Reserve rate cuts, and ongoing AI investments [6] - Long-held positions in the portfolio broke through multi-year resistance levels, contributing to overall performance [6] Key Contributors - Precigen (PGEN) was the top contributor, benefiting from the FDA approval of Papzimeos, which is expected to launch soon [10][15] - Alphabet Inc. (GOOGL) and Alibaba Group Holdings (BABA) also significantly contributed to performance, with GOOGL gaining regulatory clarity and BABA announcing aggressive AI investment plans [8][16][17] Key Detractors - Dave & Buster's Entertainment (PLAY) was the largest detractor due to disappointing results and leadership changes, although there is optimism for future recovery under new management [18] - QXO Inc. (QXO) faced concerns over weakening construction activity but continues to execute its acquisition strategy [19] - Crocs Inc. (CROX) declined following disappointing guidance and challenges with its HEYDUDE brand [20][21] Strategic Actions - The portfolio eliminated five positions during the quarter, reallocating capital towards higher conviction names [12] - The strategy continues to capitalize on market volatility, increasing positions in Delta Air Lines (DAL) and Norwegian Cruise Line Holdings (NCLH) during market pullbacks [9]

Core Insights - Precigen, Inc. announced long-term follow-up data showing durable responses to PAPZIMEOS (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), presented at the AAO-HNSF 2025 Annual Meeting [1][3] - PAPZIMEOS is the first and only FDA-approved therapy for RRP, granted full approval in August 2025 [1][7] Efficacy and Safety - The pivotal study for PAPZIMEOS met primary safety and efficacy endpoints, with 51% of patients achieving complete response, requiring no surgeries in the 12 months post-treatment [2][5] - Long-term follow-up data indicated that 83% of complete responders maintained their response with a median follow-up of 36 months, and no new safety events were observed [5][6] Impact on Patients and Healthcare System - Durable responses from PAPZIMEOS lead to fewer surgical procedures, reducing complications and long-term healthcare burdens [3] - The percentage of patients experiencing a reduction in surgeries compared to the year prior to treatment was 86% in Year 1, 91% in Year 2, and 95% in Year 3 [5][6] Background on RRP - RRP is a rare disease caused by chronic HPV 6 or HPV 11 infection, leading to severe complications and requiring repeated surgeries, which can significantly impact patients' quality of life [4] - Approximately 27,000 adult RRP patients are estimated to be in the US, highlighting the unmet medical need for effective treatments [4]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] - A specific company is highlighted as a key player in the AI energy sector, owning critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI technologies [3][7][8] Investment Landscape - Wall Street is investing hundreds of billions into AI, but there is a pressing concern regarding the energy supply needed to sustain this growth [2] - AI data centers, which power large language models like ChatGPT, consume energy equivalent to that of a small city, indicating a significant strain on global power grids [2] - The company in focus is positioned to benefit from the anticipated surge in demand for electricity driven by AI advancements [3][6] Company Profile - The company is described as a "toll booth" operator in the AI energy boom, collecting fees from energy exports and playing a crucial role in U.S. LNG exportation [5][7] - It is noted for its debt-free status and substantial cash reserves, which amount to nearly one-third of its market capitalization, providing a strong financial foundation [8][10] - The company also holds a significant equity stake in another AI-related venture, offering investors indirect exposure to multiple growth opportunities in the AI sector [9][10] Market Positioning - The company is recognized for its capability to execute large-scale engineering, procurement, and construction projects across various energy sectors, including nuclear energy [7][8] - It is suggested that the company is undervalued, trading at less than seven times earnings, which presents a compelling investment opportunity [10][11] - The influx of talent into the AI sector is expected to drive continuous innovation, further solidifying the company's position in the market [12][13] Future Outlook - The article emphasizes the importance of investing in AI and energy infrastructure as the future is increasingly reliant on these technologies [13][14] - The potential for significant returns is highlighted, with projections of over 100% returns within 12 to 24 months for investors who act promptly [15][19]