– 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 ...

Precigen, Inc. (NASDAQ:PGEN) Q4 2023 Earnings Conference Call March 19, 2024 4:30 PM ET Company Participants Steve Harasym - Vice President, Investor Relations Helen Sabzevari - President & Chief Executive Officer Harry Thomasian - Chief Financial Officer Jim Shaffer - Head of our Commercial Conference Call Participants Jason Butler - Citizens JMP Jennifer Kim - Cantor Fitzgerald Swayampakula Ramakanth - H.C. Wainwright Brian Cheng - JPMorgan Operator Good afternoon and welcome to the Precigen Full-Year 202 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 registrant as specified in its charter) Virginia 26-0084895 (State or other jurisdiction ...

Exhibit 99.1 Precigen Reports Full Year 2023 Financial Results and Business Updates GERMANTOWN, MD, March 19, 2024 – 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 full year 2023 financial results and business updates. "2024 is poised to be a transformative year for Precigen, as we are on track to present pivotal Phase 2 data in the second quarter and submit a BLA for PRGN-2012 ...

Table of Contents 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 Virginia 26-0084895 (State or other jurisdiction of incorporation or organization) For the quarterly period ended September 30, 2023 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 nam ...