Precigen

Precigen, Inc. is a biotechnology company, which engages in the research and development of synthetic biology technologies. It operates through the following segments: Biopharmaceuticals, Exemplar, and Trans Ova. The Biopharmaceuticals segment is involved in advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. It also engages in pioneering a proprietary class of microbe-based biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics. The Exemplar segment is focused on developing research models and services for healthcare research applications. The Trans Ova segment provides bovine reproductive technologies. The company was founded by Thomas David Reed in 1998 and is headquartered in Germantown, MD.

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Precigen (PGEN) reports strong Q1 performance and growth opportunities

Precigen's Q1 2023 earnings call highlighted financial strength, progress in innovative therapies, and a focus on cost-effective drug development.
The company's platforms like PRGM 2012 and UltraCAR show promise in treating challenging diseases, supported by a solid cash runway into late 2024.
While facing challenges in program transparency and target rights, Precigen's opportunities lie in rapid commercialization, personalized medicine, and market expansion.

Precigen (PGEN) reports strong Q2 performance and FDA alignment

Precigen (PGEN) shows promising performance with positive Phase I data for PRGN-2012 and cost-saving measures implemented.
Strengths lie in FDA confirmation, positive regulatory developments, and extended cash runway to 2025.
Challenges include safety follow-up, commercial readiness, and balancing program focus amidst cost-saving measures.
Opportunities arise from international licensure discussions, repeat dosing scenarios, and FDA alignment for accelerated approval.

Precigen (PGEN) projects strong growth in 2024 with key milestones

Precigen (PGEN) anticipates a significant year ahead with key milestones for PRGN-2012 and UltraCAR-T therapies.
Financially, the company aims to balance R&D investments with cost reductions to support strategic initiatives.
Analysts' inquiries and the focus on strengthening the balance sheet underscore the company's commitment to sustainable growth.

Precigen (PGEN) excels with PRGN-2012 gene therapy, poised for growth

Precigen (PGEN) showcased strong performance with PRGN-2012, supported by positive clinical trial outcomes and regulatory milestones.
While challenges like trial enrollment pace and market strategies exist, strategic initiatives and financial updates indicate a proactive approach to addressing them.
The company's focus on commercialization and workforce optimization presents opportunities for growth and market leadership in the gene therapy sector.

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GERMANTOWN, Md. , March 5, 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 Company will report fourth quarter and full year 2023 financial results on Tuesday, March 19, 2024.

Precigen to Announce Fourth Quarter and Full Year 2023 Financial Results on March 19th

GERMANTOWN, Md. , Feb. 6, 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 the Oppenheimer 34th Annual Healthcare Life Sciences Conference taking place virtually from February 13 to February 14, 2024.

Precigen to Participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference

FDA agreed to allow phase 1/2 study to serve as the basis for being able to file for Accelerated Approval of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis. A BLA filing of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis is expected in the 2nd half of 2024. It is projected that it could earn $2 billion in peak sales globally of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis.

Precigen: RRP Targeting With AdenoVerse Technology Platform

– Designation is an important step toward bringing this potentially life-changing therapy to European patients – – EU Orphan Drug Designation is the first regulatory designation for a gorilla adenovector based immunotherapy outside of the United States for the Company – GERMANTOWN, Md. , Jan. 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 the European Commission (EC) has granted Orphan Drug Designation for the Company's first-in-class investigational medicine PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP).

Precigen Receives Orphan Drug Designation for PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis from the European Commission

–   PRGN-2012 Phase 2 pivotal study data in RRP is anticipated in the second quarter of 2024; the Company plans to submit a BLA under an accelerated approval pathway in the second half of 2024; commercial readiness preparations are underway for a potential launch in 2025  – –   Company presentation scheduled for January 10 at 5:15 PM PST – GERMANTOWN, Md. , Jan. 8, 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 released highlights of pipeline updates to be presented at the 42nd Annual J.P.

Precigen Highlights Pipeline Updates to be Presented at the 42nd Annual J.P. Morgan Healthcare Conference

GERMANTOWN, Md., Dec. 18, 2023 /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 present a corporate and clinical overview at the 42nd Annual J.P.

Precigen to Present at the 42nd Annual J.P. Morgan Healthcare Conference

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GERMANTOWN, Md. , Nov. 29, 2023 /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 at the JMP Securities Hematology and Oncology Summit on Wednesday, December 6, 2023 at 3:00 PM ET.

Precigen to Participate in the JMP Securities Hematology and Oncology Summit

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–   Based on FDA confirmation in August 2023 that the ongoing Phase 1/2 single-arm study of PRGN-2012 in RRP will serve as the pivotal study to support BLA submission under an accelerated approval request, the Company has expedited efforts to attain commercial readiness – –    Full results of the Phase 1 portion of the ongoing Phase 1/2 study of PRGN-2012 were published in the peer-reviewed journal, Science Translational Medicine, and presented in an oral presentation at the ESGCT 30th Annual Congress – –   Enrollment and dosing was completed in the Phase 2 study of PRGN-2012 in RRP; Phase 2 study completion expected in the second quarter of 2024  – –   Cash, cash equivalents, short-term and long-term investments totaled $79.0 million as of September 30, 2023; cash runway projected into 2025 – –   Continued focus on cost containment resulted in a reduction in SG&A costs of 17% for the nine months ended September 30, 2023, compared to the prior year over the same period – GERMANTOWN, Md. , Nov. 9, 2023 /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 third quarter 2023 financial results and progress of clinical programs.

Precigen Reports Third Quarter 2023 Financial Results and Progress of Clinical Programs

GERMANTOWN, Md. , Nov. 7, 2023 /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 present a company overview at the Stifel 2023 Healthcare Conference on Wednesday, November 15, 2023 at 10:55 AM ET in New York.

Precigen to Participate in the Stifel 2023 Healthcare Conference

GERMANTOWN, Md. , Sept. 19, 2023 /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 the following upcoming investor and industry conferences: Cantor Global Healthcare Conference 2023 Fireside chat on Tuesday, September 26 at 4:55 PM ET New York, NY Cell & Gene Meeting on the Mesa Company presentation on Wednesday, October 11, 2023 at 3:30 PM PT Carlsbad, CA Cantor AML Virtual Panel Panel discussion on acute myeloid leukemia (AML) on Thursday, October 26, 2023 at 2:00 PM ET Virtual Participants may view details for these events through Precigen's website in the Events & Presentations section at investors.precigen.com/events-presentations.

Precigen to Participate in Upcoming Leading Investor and Industry Conferences

Precigen, Inc. (PGEN) reached a significant support level, and could be a good pick for investors from a technical perspective. Recently, PGEN's 50-day simple moving average broke out above its 200-day moving average; this is known as a "golden cross.

Should You Buy Precigen, Inc. (PGEN) After Golden Cross?

Precigen, a clinical-stage biopharmaceutical company, shows potential with flagship drug PRGN-2012 for RRP, given accelerated FDA processes. Despite financial challenges, the company's shift to in-house gene therapy manufacturing and strategic financial management seem promising. Based on clinical advancements and strategic initiatives, the investment recommendation is upgraded from "Hold" to a speculative "Buy".

Precigen's Express Lane: Racing Towards RRP Remedies (Rating Upgrade)

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Precigen, Inc. (NASDAQ:PGEN ) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Company Participants Steve Harasym - Vice President, Investor Relations Helen Sabzevari - President & Chief Executive Officer Harry Thomasian - Chief Financial Officer Conference Call Participants Jason Butler - JMP Securities Jennifer Kim - Cantor Fitzgerald Arthur He - H.C. Wainwright Ben Burnett - Stifel Brian Cheng - JPMorgan Operator Good morning and welcome to the Precigen Second Quarter and First Half 2023 Financial Results and Business Update Call.

Precigen, Inc. (PGEN) Q2 2023 Earnings Call Transcript

–   The FDA confirmed that the ongoing Phase 1/2 single arm study of PRGN-2012 in RRP will serve as the pivotal study to support accelerated approval and no additional randomized, placebo-controlled trial will be required to support submission of a BLA – –   Company to prioritize portfolio activities to accelerate PRGN-2012 and continue advancement of other key programs, by implementing strategies to reduce clinical costs (e.g., reducing CRO costs without internal R&D headcount reduction) and reduce SG&A costs – –   Completely retired the outstanding balance of convertible notes – –   Cash, cash equivalents, short-term and long-term investments totaled $95.6 million as of June 30, 2023; cash runway projected into 2025 – GERMANTOWN, Md.

Precigen Reports Second Quarter and First Half 2023 Financial Results and Provides Update on Portfolio Prioritization and Capital Allocation Strategies to Extend Projected Cash Runway into 2025

–   FDA confirmed that the ongoing Phase 1/2 single arm study will serve as pivotal and no additional randomized, placebo-controlled trial will be required to support submission of a BLA  –  –   FDA agreed on the required efficacy and safety endpoints that will support filing an accelerated approval BLA for licensure – –   E nrollment and dosing in the ongoing Phase 2 portion of the study is completed – –   If approved, PRGN-2012 would potentially be the first therapeutic for the treatment of RRP, a serious and difficult-to-treat orphan indication for which the current standard-of-care is repeated surgeries   – GERMANTOWN, Md. , Aug. 9, 2023 /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 US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in-class investigational PRGN-2012 AdenoVerse™ immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure.

Precigen Announces FDA Confirmation that the Ongoing Phase 1/2 Study of PRGN-2012 AdenoVerse Immunotherapy Will Serve as the Pivotal Study to Support Accelerated Approval

GERMANTOWN, Md. , Aug. 3, 2023 /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 Company will release second quarter and first half 2023 financial results on Wednesday, August 9, 2023.

Precigen to Announce Second Quarter and First Half 2023 Financial Results on August 9th

–  First FDA Breakthrough Therapy Designation granted for AdenoVerse immunotherapy platform; designation prioritizes PRGN-2012 as a potential treatment for RRP – –  Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete Response) after PRGN-2012 treatment with a minimum follow up of 12 months post-treatment – GERMANTOWN, Md. , June 20, 2023 /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 US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the first-in-class investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP).

Precigen Receives Breakthrough Therapy Designation for PRGN-2012 AdenoVerse™ Immunotherapy for the Treatment of Recurrent Respiratory Papillomatosis

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– PRGN-3005 was well-tolerated with no dose limiting toxicities, no CRS greater than Grade 2, and no neurotoxicity – – PRGN-3005 cells demonstrated expansion and persistence when delivered via either intraperitoneal or intravenous infusion without lymphodepletion or via intravenous infusion after lymphodepletion demonstrating the effectiveness of mbIL15 – – A single intravenous infusion following lymphodepletion decreased tumor burden in 67% of the heavily pretreated patients (median of 8 or more prior therapies) with 90% of individual target lesions showing stable disease or partial response – – PRGN-3005 UltraCAR-T cells are being evaluated in the Phase 1b dose expansion study with intravenous infusion following lymphodepletion and incorporating repeat infusion – – Best responder achieved stable disease for more than 18 months after failing 9 prior lines of treatment; results achieved with two doses of UltraCAR-T cells in the low millions – GERMANTOWN, Md. , June 5, 2023 /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 presented positive data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase 1 portion of the Phase 1/1b clinical study evaluating safety and efficacy of PRGN-3005 UltraCAR-T® in advanced stage platinum resistant ovarian cancer patients (Abstract# 5590).

Precigen Announces Positive Phase 1 Data for PRGN-3005 Autologous UltraCAR-T® Cells Manufactured Overnight for Infusion Next Day to Advanced Stage Platinum Resistant Ovarian Cancer Patients

–  PRGN-2009 combined with an investigational checkpoint inhibitor resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers that were naïve or resistant to checkpoint blockade with prolonged duration of responses – –  Recurrent/metastatic HPV-associated cancers (cervical, anal, oropharyngeal, etc.) are incurable by current therapies – –  PRGN-2009 was safe and well-tolerated with only Grade 1 or 2 treatment related adverse events – –  PRGN-2009 treatment induced HPV-specific T-cell immune responses and subsequently enhanced T-cell responses with repeat administrations without the development of neutralizing antibodies in the majority of patients – GERMANTOWN, Md.

Precigen Announces Positive Phase 1 Data for Off-the-Shelf PRGN-2009 AdenoVerse™ Immunotherapy Alone and in Combination with an Investigational Checkpoint Inhibitor in Patients with Recurrent/Metastatic HPV-associated Cancers

–  HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US – –  Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity  – – PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is differentiated from other platforms due to the ability of gorilla adenovectors to enable repeat administrations – –  PRGN-2009 Phase 1 data to be presented at the 2023 ASCO annual meeting on June 3 (Abstract # 2628); PRGN-2009 in combination with a checkpoint inhibitor demonstrated a favorable safety profile and resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers, including those who have previously failed checkpoint inhibitors – –  Phase 2 study of PRGN-2009 is in combination with pembrolizumab in the second line setting in patients with recurrent or metastatic cervical cancer previously treated with pembrolizumab for recurrent or metastatic disease  – –  CMC path in place to support delivery of product for Phase 2 study as well as future framework to support potential pivotal trials – GERMANTOWN, Md. , May 31, 2023 /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 US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase 2 study of the first-in-class PRGN-2009 Off-the-Shelf (OTS) AdenoVerse ™ immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer.

Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer

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