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 ...

Regulatory and Clinical Developments - Precigen completed a pre-BLA meeting with the FDA and is aligned on the content for the BLA submission for PRGN-2012, expected in Q4 2024[1] - The pivotal clinical study for PRGN-2012 showed that 51% of patients achieved a Complete Response, with a median follow-up duration of 20 months[5] - The company is preparing for an end of Phase 1b meeting with the FDA for PRGN-3006 in AML in early 2025[1] Financial Performance - Total revenues decreased by $0.4 million, or 31%, compared to the same period in 2023, primarily due to reductions in product and service revenues at Exemplar[20] - Net loss for Q3 2024 was $24.0 million, or $(0.09) per share, compared to a net loss of $19.8 million, or $(0.08) per share, in Q3 2023[20] - Total revenues for Q3 2024 were $953,000, a decrease of 30.8% compared to $1,379,000 in Q3 2023[30] - Product revenues in Q3 2024 were $66,000, down from $82,000 in Q3 2023, representing a decline of 19.5%[30] - Service revenues decreased to $886,000 in Q3 2024 from $1,296,000 in Q3 2023, a drop of 31.6%[30] - The net loss for Q3 2024 was $23,978,000, compared to a net loss of $19,795,000 in Q3 2023, reflecting an increase in losses of 11.0%[30] - The accumulated deficit increased to $(2,070,979,000) as of September 30, 2024, from $(1,964,471,000) at the end of 2023[29] Expenses and Liabilities - Research and development expenses increased by $5.7 million, or 16%, compared to the nine months ended September 30, 2023, driven by costs associated with PRGN-2012[22] - SG&A expenses increased by $0.6 million, or 7%, in Q3 2024, attributed to increased focus on PRGN-2012 and severance costs from workforce reduction[17] - Total operating expenses for Q3 2024 were $22,215,000, slightly down from $22,316,000 in Q3 2023[30] - Current liabilities decreased slightly to $21,216,000 from $22,985,000 at the end of 2023[29] Asset Management - Cash and cash equivalents rose to $24,725,000 as of September 30, 2024, compared to $7,578,000 at the end of 2023[29] - Total assets decreased to $83,474,000 as of September 30, 2024, down from $151,043,000 at the end of 2023[29] - The weighted average shares outstanding increased to 275,881,170 in Q3 2024 from 248,520,724 in Q3 2023[30] Strategic Initiatives - Precigen's UltraCAR-T platform is positioned to potentially be best-in-class for CD19-targeting treatments in oncology and autoimmune diseases[2] - The company is exploring various financing options, including strategic partnerships, to support the commercialization of PRGN-2012[2] - The company recorded $34.5 million in impairment charges related to goodwill and long-lived assets due to the suspension of ActoBio's operations[24]

–   Completed pre-BLA meeting with FDA with full alignment on content of BLA, including CMC module, and path for fourth quarter 2024 rolling BLA submission for PRGN-2012† in RRP under accelerated approval pathway ––   Commercial and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch ––   Confirmatory clinical trial for PRGN-2012 in RRP was initiated in accordance with guidance from FDA to initiate prior to submission of the BLA; continuing enrollment ––   Prep ...

GERMANTOWN, Md., Nov. 12, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced Helen Sabzevari, PhD, President and CEO of Precigen, will participate in a fireside chat on Tuesday, November 19, 2024 from 10:55 to 11:25 AM ET at the Stifel 2024 Healthcare Conference taking place November 18 to 19, 2024 in New York.Event details can be found on Precigen's website in ...

GERMANTOWN, Md., Sept. 16, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that Helen Sabzevari, PhD, President and CEO of Precigen, will participate in a fireside chat on Wednesday, September 18, 2024 from 9:45 to 10:15 AM ET at the 2024 Cantor Global Healthcare Conference taking place September 17 to 19, 2024 in New York. Participants may view details for ...

Precigen, Inc. (PGEN) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to loss of $0.08 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of -11.11%. 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 be ...