GERMANTOWN, Md., Aug. 7, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) today announced the pricing of an underwritten public offering of 35,294,118 shares of its common stock at a public offering price of $0.85 per share. Precigen has also granted the underwriters a 30-day option to purchase up to an additional 5,294,117 shares of its common stock. Gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately ...

Wall Street expects a year-over-year decline in earnings on lower revenues when Precigen, Inc. (PGEN) reports results for the quarter ended June 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock ...

GERMANTOWN, Md., July 23, 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 the appointment of Phil Tennant as the Company's chief commercial officer. Mr. Tennant will be responsible for commercial strategy and execution across US and global markets. His initial focus will be on driving commercial readiness activities for the potential launch of the first- and ...

– Phase 1/2 pivotal study met the primary safety and efficacy endpoints – – 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; complete responses have been durable beyond 12 months with median duration of follow up of 20 months as of data cutoff – – 86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 pre-tre ...

GERMANTOWN, Md., May 23, 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 the Company will host a webcast on June 3, 2024 at 6:00 PM CT/7:00 PM ET following the late-breaking oral presentation of results from the pivotal study of PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP) at the 2024 American Society of Clinical Oncology (A ...

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 $0.10 per share a year ago. These figures are adjusted for non- recurring 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 $0.08 per share when it actually produced a loss of $0.09, delivering a surprise of -12.50%. Over the last four quarters, the company has surp ...

Washington, D.C. 20549 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 (Exact name of registrant as specified in its charter) Virginia 26-0084895 (State or other jurisdiction of incorporation or organization) 20374 Seneca Meadows Parkway Germantown, Mar ...

Financial Performance - Total revenues decreased by $0.8 million, or 43%, compared to the three months ended March 31, 2023[14]. - Total revenues for Q1 2024 were $1,065,000, a decrease of 42.3% compared to $1,851,000 in Q1 2023[29]. - Product revenues decreased to $138,000 from $324,000, while service revenues fell to $919,000 from $1,527,000[29]. - Operating loss for Q1 2024 was $24,410,000, compared to a loss of $23,478,000 in Q1 2023[29]. - Net loss was $23.7 million, or $(0.10) per basic and diluted share, compared to a net loss of $22.7 million, or $(0.10) per basic and diluted share, in the prior year[14]. - Net loss for Q1 2024 was $23,738,000, consistent with a net loss of $22,734,000 in Q1 2023[29]. - The company reported a net loss per share of $0.10 for both Q1 2024 and Q1 2023[29]. Research and Development - Research and development expenses increased by $2.1 million, or 17%, compared to the same period in 2023[12]. - Research and development expenses increased to $14,249,000, up from $12,163,000 in the same period last year[29]. - 50% of patients in the Phase 1 portion of the PRGN-2012 study achieved Complete Response, defined as no surgeries needed during the 12-month period following treatment[6]. - 83% of patients had a reduction in RRP surgeries in the 12-month period after PRGN-2012 treatment compared to the 12 months pre-treatment[7]. - The FDA confirmed that the ongoing Phase 1/2 study of PRGN-2012 will serve as pivotal, eliminating the need for additional randomized trials for BLA submission[9]. - Precigen is advancing its UltraCAR-T library approach to enhance personalized cell therapy for cancer patients[21]. Cash and Assets - Cash, cash equivalents, and short-term investments totaled $44.8 million as of March 31, 2024[11]. - Cash and cash equivalents rose to $17,478,000 as of March 31, 2024, compared to $7,578,000 at the end of 2023[27]. - Total assets decreased to $134,847,000 from $151,043,000 at the end of 2023[27]. - Total liabilities increased to $37,828,000 from $32,545,000 at the end of 2023[27]. Corporate Initiatives - The company plans to co-sponsor the inaugural RRP Awareness Day on June 11, 2024, to raise awareness about recurrent respiratory papillomatosis[5]. - PRGN-2012 rolling BLA submission is anticipated in the second half of 2024, with commercial readiness activities underway for a potential launch in 2025[5]. Operating Expenses - SG&A costs decreased by $1.5 million, or 13%, compared to the same period in 2023[13].

– Pivotal Phase 2 study data of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis to be presented at the 2024 ASCO Annual Meeting as a late-breaking oral presentation on June 3rd – – Company to host a conference call on June 3rd following the PRGN-2012 ASCO presentation to discuss in detail the pivotal study results and provide business updates – – PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; commercial re ...

Financial Data and Key Metrics Changes - The company reported a decrease in SG&A costs by 16% or $7.6 million from the prior year, totaling $40.4 million for the full year of 2023, primarily due to reduced legal and insurance costs [26] - Research and development expenses increased by 3% or $1.4 million from the prior year, totaling $48.6 million, mainly due to additional personnel investments [48] Business Line Data and Key Metrics Changes - The lead asset PRGN-2012 is on track for pivotal Phase 2 data presentation in Q2 2024 and BLA submission in the second half of 2024, supported by positive FDA guidance [3][9] - The company is also advancing PRGN-2009 for HPV-related cancers, with a Phase 2 study currently recruiting patients [10][45] Market Data and Key Metrics Changes - The estimated patient population for RRP (Recurrent Respiratory Papillomatosis) in the U.S. is between 15,000 to 20,000, with over 125,000 patients estimated outside the U.S. [20] - The company anticipates a swift uptake of PRGN-2012 due to a small number of specialty physicians managing the majority of RRP patients [40] Company Strategy and Development Direction - The company is focused on transitioning from a clinical to a commercial stage, with plans for a drug substance manufacturing facility in Germantown, Maryland, and a commercial launch of PRGN-2012 expected in 2025 [25][52] - The strategy includes building a specialty sales team to increase awareness and promote the product once approved [54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to strengthen the balance sheet as the company approaches the planned launch of PRGN-2012 [13][69] - The company views 2024 as a transformative year, with multiple value inflection points expected, starting with the data readout on PRGN-2012 [25][71] Other Important Information - The company has received breakthrough designation and an accelerated path from the FDA for PRGN-2012, allowing for a combined Phase 1 and Phase 2 trial to be considered pivotal [23] - The company is also exploring opportunities in the UltraCAR-T space, with ongoing discussions about partnerships and commercialization strategies [68] Q&A Session Summary Question: Can you provide more details on the confirmatory study design for PRGN-2012? - The design of the confirmatory study will be the same as the Phase 1 and Phase 2 studies, with a total of 35 patients to be reported on [29][50] Question: What is the plan for presenting the Phase 2 data? - The company is considering various options for presenting the Phase 2 data and will provide guidance as the date approaches [33] Question: How will the commercialization strategy be structured for PRGN-2012? - The company has completed market research to understand the dynamics of RRP treatment and plans to focus on a small group of specialty physicians managing the majority of patients [35][40] Question: What is the expected adoption trajectory for PRGN-2012 if approved? - The company anticipates a relatively swift uptake due to the small number of laryngologists managing RRP patients, with a potential three to four-year uptake curve to peak [40][56]