GERMANTOWN, Md., Jan. 5, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company advancing innovative precision medicines, today announced that Helen Sabzevari, PhD, President and Chief Executive Officer of Precigen, will present at the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12–15, 2026 in San Francisco, California. Dr. Sabzevari's company presentation is scheduled for Thursday, January 15, 2026 at 7:30 AM PT. Steven M. Harasym Tel: +1 (202) 365-2563 inve ...

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Company Overview - Precigen operates in the biotechnology sector, focusing on developing next-generation gene and cell therapies through proprietary platforms and innovative genetic engineering [5][7] - The company has a market capitalization of $1.2 billion and reported a revenue of $6.3 million for the trailing twelve months (TTM) [4] - Precigen's net income for the TTM is a loss of $425.9 million, with a significant third-quarter net loss attributable to common shareholders of $325 million, primarily due to non-cash items [4][10] Recent Developments - On November 14, Tang Capital Management disclosed a new position in Precigen, acquiring 12.4 million shares valued at approximately $40.8 million, representing 1.6% of the fund's $2.6 billion in U.S. equity assets [2][9] - Precigen's stock price has increased by 282% over the past year, closing at $3.48, significantly outperforming the S&P 500, which rose by 13% in the same period [3] Product and Market Position - The company has launched PAPZIMEOS, the first FDA-approved therapy for recurrent respiratory papillomatosis, which has shown strong early demand with over 100 patients enrolled in its Patient Hub [8][10] - Precigen's strategy includes targeting unmet medical needs with disease-modifying therapeutics and engineered solutions, aiming to establish a competitive edge in the evolving healthcare landscape [5][10]

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 is a 5% increase from the previous year [2] - Competitive analysis shows that the company is outperforming its main rivals, which have only seen a 3% growth in the same period [2] Future Outlook - Analysts predict continued growth for the company, with expectations of a 12% increase in revenue for the next fiscal year, driven by new product launches and market expansion [2] - The company is also exploring strategic partnerships to enhance its service offerings and customer reach [2]

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]