â"¢ GERMANTOWN, Md., Jan. 20, 2026 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced the publication of a new expert consensus paper sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of recurrent respiratory papillomatosis (RRP) has been published in The Laryngoscope, one of the f ...

Company Overview - Precigen Therapeutics is a biotech company focused on cell and gene therapy for various indications, including rare diseases and oncology [3] - The company is based in Maryland and aims to utilize differentiated technology and platforms tailored to specific indications with a clear regulatory strategy [3] Product Development - Precigen has successfully developed its first drug, PAPZIMEOS, which received approval in a rapid timeframe of four years from discovery to development [3]

Summary of Precigen's Presentation at the J.P. Morgan Healthcare Conference Company Overview - **Company**: Precigen - **Industry**: Biotechnology, focusing on cell and gene therapy for rare diseases and oncology - **Location**: Maryland, USA - **Key Product**: Pepcimeus, an FDA-approved drug for recurrent respiratory papillomatosis (RRP) [2][9] Core Points and Arguments Advancements in Technology and Product Development - Precigen utilizes a differentiated adenovirus platform, specifically gorilla adenoviral vectors, which have a payload capacity of 12 to 15 kb, allowing for more genes to be delivered compared to traditional adenoviruses [3][4] - The platform enables repeat dosing without the high titers of neutralizing antibodies that typically inhibit efficacy in other adenoviral vectors, promoting T cell immunity [5][6] - Pepcimeus was developed and received FDA approval in just four years, showcasing the efficiency of Precigen's development process [3][9] Clinical Data and Patient Impact - Pepcimeus is the first FDA-approved therapy for RRP, a condition caused by HPV 6 and 11, leading to benign tumors in the respiratory tract [10][12] - Clinical trials showed that patients who previously underwent multiple surgeries experienced significant reductions in surgical needs after receiving Pepcimeus [15][16] - The drug is administered subcutaneously, similar to a flu vaccine, making it easy for patients to receive [13][14] Market Potential and Commercialization Strategy - The U.S. market for RRP is estimated at 27,000 patients, with potential expansion to 35,000 patients in Europe and 85,000 in China [17][22] - Precigen has secured coverage for Pepcimeus through Medicare, Medicaid, and over 170 million lives across various private health insurances, achieving nearly 80% coverage within a quarter of launch [19][37] - The company has established a patient support hub, which has seen rapid growth in patient enrollment, indicating strong market interest [20][21] Future Plans and Regulatory Strategy - Precigen plans to expand Pepcimeus' indications to pediatric patients and is pursuing regulatory approval in the EU and Japan [23][24] - The company aims to leverage its adenovirus platform for additional indications, including HPV-related cancers, with ongoing Phase 2 trials [24][25] Additional Important Insights - The transition from surgical to medical management of RRP represents a significant shift in treatment paradigms, with the potential to improve patient outcomes and reduce the need for invasive procedures [31][32] - Precigen's leadership team has demonstrated expertise in navigating the complexities of drug development and commercialization, contributing to the company's rapid progress since its inception in 2020 [25][26] - The company is focused on establishing partnerships for international expansion while maintaining a primary focus on the U.S. market [39][40]

PAPZIMEOS Approval and Launch - PAPZIMEOS received full FDA approval in 2025 for treating all adults with RRP, regardless of disease severity[10, 14] - PAPZIMEOS is the first and only FDA-approved therapy for adults with RRP, targeting the underlying cause of the disease[16] - The company commenced the commercial US launch of PAPZIMEOS and initiated its commercial manufacturing campaign in 2025[10] - Over 50 accounts, including academic and community settings, have prescribed PAPZIMEOS[33] - The company has seen a rapid increase in unaided brand awareness of PAPZIMEOS across academic and community settings[34] Clinical Data and Efficacy - Clinical data shows a 51% complete response rate with PAPZIMEOS, with durable ongoing complete responses[21] - PAPZIMEOS significantly reduced the number of surgeries required post-treatment, with p<0001[22] - Median duration of follow-up was at 36 months (27-37), and the median duration of complete response has yet to be reached[25] Market Opportunity and Expansion - The prevalence of RRP in the US is approximately 27000 adult patients, suggesting a multi-billion-dollar revenue potential[30] - The prevalence of RRP ex-US is approximately 35000 adults in EU4, UK, and Japan, approximately 50000 adults in the rest of EU and select markets, and approximately 85000 adults in China, suggesting a multi-billion-dollar revenue potential[30] - The company anticipates PAPZIMEOS regulatory expansion to the EU and Japan[37] Financials and Future Milestones - The company secured up to $125 million in non-dilutive funding to fortify its balance sheet[10] - The company aims to achieve positive cash flow in 2026 by continuing execution and expansion to maximize the PAPZIMEOS market opportunity[37]

Core Insights - Precigen, Inc. is set to present at the 44th Annual J.P. Morgan Healthcare Conference from January 12–15, 2026, with CEO Helen Sabzevari scheduled to speak on January 15, 2026, at 7:30 AM PT [1] - Dr. Sabzevari will also participate in a fireside chat hosted by Eversana on January 12, 2026, at 10:30 AM PT during the Biotech Showcase [2] - Precigen focuses on developing innovative precision medicines for difficult-to-treat diseases, with a strong pipeline in immuno-oncology, autoimmune disorders, and infectious diseases [3] Company Overview - Precigen, Inc. specializes in advancing precision medicines aimed at addressing high unmet patient needs [3] - The company is committed to moving scientific breakthroughs from proof-of-concept to commercialization [3] - Precigen is developing a robust pipeline of differentiated therapies across its core therapeutic areas [3]

Group 1 - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 100 points on Monday [1] - DigitalBridge Group Inc announced its acquisition by SoftBank Group for an enterprise value of approximately $4.0 billion, resulting in a 9.9% increase in its shares to $15.30 [1] Group 2 - Eightco Holdings Inc shares surged 29.1% to $2.15 following the announcement of a share buyback program for up to $125 million [2] - Palisade Bio Inc saw an 18.6% increase to $2.55 after Piper Sandler initiated coverage with an Overweight rating and a price target of $25 [2] - Regencell Bioscience Holdings Ltd gained 16.3% to $24.60 [2] - Praxis Precision Medicines Inc surged 13% to $304.00 after receiving Breakthrough Therapy Designation from the FDA for ulixacaltamide [2] - Zura Bio Ltd increased by 13% to $5.26 [2] - Precigen Inc rose 8.6% to $4.52 [2] - Autolus Therapeutics PLC jumped 7.8% to $1.80, with Needham analyst raising the price target from $10 to $11 [2] - LightPath Technologies Inc gained 6.6% to $9.62 [2] - NGL Energy Partners LP surged 6.3% to $9.98 [2] - Six Flags Entertainment Corp increased by 5% to $15.64 [2]

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]