Group 1 - Precigen, Inc. will release its full year 2024 financial results and provide business updates on March 19, 2025 [1] - A conference call to discuss the results will be held on the same day at 4:30 PM ET [1] - The conference call can be accessed via specific phone numbers for North America and international participants [2] Group 2 - Precigen is a biopharmaceutical company focused on developing innovative gene and cell therapies targeting serious diseases in immuno-oncology, autoimmune disorders, and infectious diseases [3] - The company operates a preclinical and clinical pipeline aimed at achieving clinical proof-of-concept and commercialization of its therapies [3]

Group 1 - The article discusses the investment opportunities in the biotechnology sector, particularly focusing on Precigen (NASDAQ: PGEN) and its AdenoVerse Technology Platform [2] - The author operates the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and a model portfolio of small and mid-cap stocks [2] - The service includes over 600 biotech investing articles and aims to assist healthcare investors in making informed decisions [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Precigen or the biotechnology sector [1][3][4]

Core Insights - The FDA has accepted Precigen's biologics license application (BLA) for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP), with a priority review timeline of 6 months and a target action date of August 27, 2025 [1][5] - If approved, PRGN-2012 would be the first FDA-approved therapy for RRP, a rare disease currently managed through repeated surgeries [3][5] - The therapy aims to elicit immune responses against HPV 6 and HPV 11, which are responsible for RRP [2][3] Company Overview - Precigen, Inc. is a biopharmaceutical company focused on innovative gene and cell therapies, with a commitment to addressing serious medical conditions [1][7] - The company utilizes its AdenoVerse platform for gene delivery, which is designed to enhance immune responses and treat complex diseases [6][7] Clinical Study Results - The pivotal Phase 1/2 clinical study for PRGN-2012 demonstrated that over 50% of patients achieved a Complete Response, and more than 85% experienced a reduction in surgical interventions in the year following treatment [4] - The therapy was well-tolerated, with no dose-limiting toxicities or treatment-related adverse events greater than Grade 2 [4] Market Need - RRP is a chronic disease with no current cure, leading to a high unmet need for effective therapeutic alternatives [3][5] - The patient population in the U.S. is estimated to exceed 27,000 adults, highlighting the potential market for PRGN-2012 if approved [5]

Group 1 - Precigen, Inc. (PGEN) has reached a key level of support, with its 50-day simple moving average crossing above its 200-day simple moving average, indicating a "golden cross" which is a bullish signal for potential breakout [1] - A golden cross consists of three stages: a downtrend that bottoms out, the shorter moving average crossing above the longer moving average, and the stock continuing to rise [2] - PGEN has experienced a significant rally of 79.7% over the past four weeks, and currently holds a 3 (Hold) rating on the Zacks Rank, suggesting it may be poised for further breakout [3] Group 2 - The positive earnings outlook for PGEN is reinforced by the fact that no earnings estimates have been cut for the current quarter, with one revision higher in the past 60 days and an increase in the Zacks Consensus Estimate [3] - Given the key technical level and positive earnings estimate revisions, investors may want to monitor PGEN for potential gains in the near future [4]

Core Insights - PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of recurrent respiratory papillomatosis (RRP), a rare and chronic disease [5][10] - The company has completed the Biologics License Application (BLA) submission for PRGN-2012 for adults with RRP and is preparing for a potential launch in the second half of 2025 [1][10] - The market opportunity for PRGN-2012 in the US is estimated to be approximately 27,000 adult patients, with expectations of over 125,000 patients outside the US [2][10] - The company has approximately $100 million in cash on hand, providing a cash runway well into 2026, beyond the anticipated launch [1][10] - The AdenoVerse platform has significant market potential in other HPV6/11-driven indications, such as genital warts, and HPV16/18-driven indications, including cervical cancer and head and neck cancers [1][3] Company Readiness and Strategy - The company is actively engaged in commercial readiness activities, including payer and prescriber analysis, to ensure a successful launch of PRGN-2012 [2][3] - Manufacturing capabilities are in place, with a 100% success rate demonstrated to date, to meet projected demand for PRGN-2012 [2][3] - The company is also preparing for submissions to other health authorities in prioritized global markets [3] Clinical and Regulatory Developments - PRGN-2012 received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA, which supports its expedited review process [10] - The BLA submission is currently in the initial 60-day review period, during which the FDA will decide on further review and set the Prescription Drug User Fee Act (PDUFA) action date [10] - Data from the Phase 1/2 pivotal study indicated that over 50% of patients achieved a Complete Response, and more than 85% had a decrease in surgical interventions after treatment [10] Future Directions - The company plans to pursue strategic partnerships to advance its UltraCAR-T programs, which deliver autologous, antigen-specific CAR-T cells [3] - An end of Phase 1b meeting with the FDA for PRGN-3006 is being prepared to discuss promising clinical biomarker data that may enhance patient stratification and efficacy [3][10]

Core Insights - Precigen, Inc. is a biopharmaceutical company focused on innovative gene and cell therapies aimed at improving patient outcomes [1][3] - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 16, 2025, at 9:00 AM PT in San Francisco [1] Company Overview - Precigen specializes in the development of next-generation gene and cell therapies using precision technology to address urgent diseases in immuno-oncology, autoimmune disorders, and infectious diseases [3] - The company operates a preclinical and clinical pipeline of differentiated therapies, progressing towards clinical proof-of-concept and commercialization [3]

Core Insights - PRGN-2012 has the potential to be the first FDA-approved therapeutic for adults with recurrent respiratory papillomatosis (RRP), a rare and chronic disease requiring repeated surgeries as the current standard of care [1][9] - The biologics license application (BLA) for PRGN-2012 has been submitted to the FDA and is currently under a 60-day review period, with a request for priority review to expedite the process [8][15] - The BLA is supported by a pivotal Phase 1/2 clinical study showing that over 50% of patients achieved a Complete Response and more than 85% had a decrease in surgical interventions post-treatment [1][3] Company Overview - Precigen, Inc. is a biopharmaceutical company focused on developing innovative gene and cell therapies targeting urgent diseases in immuno-oncology, autoimmune disorders, and infectious diseases [5] - The company utilizes its proprietary AdenoVerse platform for efficient gene delivery, aiming to generate durable immune responses against diseases caused by human papillomavirus (HPV) [4][2] - Precigen's financial position has been strengthened to support the potential commercial launch of PRGN-2012 in the second half of 2025, extending its cash runway into 2026 [15]

Core Viewpoint - Precigen, Inc. has entered into a securities purchase agreement for the sale of its 8.00% Series A Convertible Perpetual Preferred Stock in a private placement, expecting gross proceeds of $79.0 million before expenses [6]. Group 1: Private Placement Details - The private placement was led by affiliates of Patient Capital Management, with participation from notable investors including Bill Miller and Randal J. Kirk [1]. - The offering includes warrants allowing investors to purchase 52,666,669 shares of Precigen's common stock at an exercise price of $0.75 per share [6]. - The Preferred Stock will be redeemable for cash at Precigen's option, with dividends paid annually in cash or in kind for the first two years [2][7]. Group 2: Financial Projections and Use of Proceeds - The net proceeds from the offering will be used for working capital and general corporate purposes, extending Precigen's cash runway into 2026 [12]. - The financing is expected to support the anticipated commercial launch of PRGN-2012 in the second half of 2025, if approved [12]. Group 3: Conversion and Registration Rights - The Preferred Stock is convertible into common stock at an initial conversion price of approximately $1.125, which is 150% of the warrant exercise price [8]. - Precigen has agreed to grant investors certain registration rights concerning the Preferred Stock and common stock issuable upon conversion and exercise of the Warrants [4].

Precigen, Inc. (PGEN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to loss of $0.08 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -12.50%. A quarter ago, it was expected that this company would post a loss of $0.09 per share when it actually produced a loss of $0.10, delivering a surprise of -11.11%.Over the last four quarters, the company has not bee ...

Table of Contents Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 001-36042 PRECIGEN, INC. (Exact name of ...