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]

Group 1 - Precigen, Inc. (NASDAQ: PGEN) shares have significantly increased following the FDA's full approval of its recurrent respiratory papillomatosis therapy, Papzimeos, on August 14th, marking the first-ever approval for this indication [2] Group 2 - The Biotech Forum, led by Bret, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions on trade ideas and weekly market commentary [2]

Group 1: AI Investment Opportunity - Artificial intelligence is identified as the greatest investment opportunity of our lifetime, with a strong emphasis on the urgency to invest now [1] - Wall Street is investing hundreds of billions into AI, but there is a critical question regarding the energy supply needed to support this technology [2] - AI data centers consume massive amounts of energy, comparable to the energy needs of small cities, leading to concerns about power grid strain and rising electricity prices [2] Group 2: Company Overview - 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 [3][7] - This company is positioned to benefit from the surge in demand for electricity driven by AI data centers, making it a potentially valuable investment in the digital age [3] - The company is debt-free and has a significant cash reserve, amounting to nearly one-third of its market capitalization, which provides financial stability and growth potential [8] Group 3: Market Position and Strategy - The company plays a crucial role in U.S. LNG exportation, which is expected to grow under the current administration's energy policies [7] - It is capable of executing large-scale engineering, procurement, and construction projects across various energy sectors, including oil, gas, and renewable fuels [7] - The company also holds a substantial equity stake in another AI-related venture, providing investors with indirect exposure to multiple growth opportunities in the AI sector [9] Group 4: Investment Appeal - The stock is described as undervalued, trading at less than 7 times earnings, which presents a compelling investment opportunity compared to other energy and utility firms [10] - The company is not just a speculative investment; it generates real cash flows and owns critical infrastructure, making it a solid choice for investors looking to capitalize on the AI and energy convergence [11] - The influx of talent into the AI sector ensures continuous innovation, further solidifying the investment case for companies involved in AI infrastructure [12]