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. , 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.

Precigen to Participate in the Stifel 2024 Healthcare Conference

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.

Precigen to Participate in the 2024 Cantor Global Healthcare Conference

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Precigen, Inc. (NASDAQ:PGEN ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Steven Harasym - VP, IR Helen Sabzevari - President & CEO Harry Thomasian - CFO Phil Tennant - Chief Commercial Officer Rutul Shah - COO Conference Call Participants Carolina Ibanez Ventoso - Stifel Jason Butler - Citizens JMP Swayampakula Ramakanth - H.C. Wainwright Jennifer Kim - Cantor Fitzgerald Operator Good evening and welcome to the Precigen's Second Quarter and First Half 2024 Financial Results Call.

Precigen, Inc. (PGEN) Q2 2024 Earnings Call Transcript

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.

Precigen, Inc. (PGEN) Reports Q2 Loss, Misses Revenue Estimates

– In June 2024, the Company announced groundbreaking pivotal study data for PRGN-2012 gene therapy at the 2024 ASCO annual meeting in which more than half of RRP patients achieved Complete Response – – In July 2024, the Company appointed Phil Tennant as Chief Commercial Officer to spearhead potential PRGN-2012 commercial launch – – In August 2024, the Company announced a strategic reprioritization of its pipeline to focus on advancement of its lead program, PRGN-2012 in RRP – – PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; the Company has initiated enrollment in the confirmatory clinical trial of PRGN-2012 – – In August 2024, the Company strengthened its cash position by raising approximately $31.4 million via a public offering of common stoc k – GERMANTOWN, Md. , Aug. 14, 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 second quarter and first half 2024 financial results and business updates.

Precigen Reports Second Quarter and First Half 2024 Financial Results and Business Updates

GERMANTOWN, Md. , Aug. 9, 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 release second quarter and first half 2024 financial results and provide business updates on Wednesday, August 14, 2024.

Precigen to Announce Second Quarter and First Half 2024 Financial Results on August 14th

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 Announces Pricing of $30.0 Million Public Offering of Common Stock

Precigen (PGEN) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Precigen, Inc. (PGEN) Q2 Earnings Expected to Decline

GERMANTOWN, Md. , Aug. 6, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) today announced it has commenced a $30.0 million underwritten public offering of its common stock.

Precigen Announces Proposed $30 Million Public Offering of Common Stock

– PRGN-2012 is on track for a rolling BLA submission under an accelerated approval pathway; patient enrollment initiated in the confirmatory clinical trial – GERMANTOWN, Md. , Aug. 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 a strategic reprioritization of the Company's clinical portfolio and streamlining of resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of the PRGN-2012 AdenoVerse ®  gene therapy for the treatment of recurrent respiratory papillomatosis (RRP).

Precigen Strategically Prioritizes Portfolio to Focus on First Potential Gene Therapy Launch

–  Company strengthens focus on building and optimizing commercial readiness and pre-launch activities for PRGN-2012 in recurrent respiratory papillomatosis  – 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.

Precigen Appoints Phil Tennant as Chief Commercial Officer to Spearhead First Potential Gene Therapy Launch

–   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-treatment to 0 post-treatment – –   PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 – –   PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders – –   PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders – –   RRP is a rare, devastating HPV-mediated chronic disease characterized by growth of benign tumors for which the current standard-of-care is repeated surgeries ; if approved, PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of RRP – –   Clinical data associated with favorable safety, strong efficacy, ease of administration, and immunological responses, position PRGN-2012 to potentially be the preferred treatment-of-choice for RRP – –   PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024 – –   Precigen to host webcast event today at 6:00 PM CT / 7:00 PM ET – GERMANTOWN, Md. , June 3, 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 positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse ® gene therapy in patients with recurrent respiratory papillomatosis (RRP).

Precigen Announces Groundbreaking Pivotal Study Data for PRGN-2012 in Patients with Recurrent Respiratory Papillomatosis in Which More than Half of Patients Achieved Complete Response

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 (ASCO) Annual Meeting.

Precigen to Host a Webcast on June 3rd to Detail Pivotal Study Results of PRGN-2012 in Recurrent Respiratory Papillomatosis Presented at the 2024 ASCO Annual Meeting

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.

Precigen, Inc. (PGEN) Reports Q1 Loss, Misses Revenue Estimates

–   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 3 rd – –   Company to host a conference call on June 3 rd 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 readiness activities underway for a potential launch in 2025 – –   Two trial-in-progress presentations for PRGN-2009 in combination with pembrolizumab for the treatment of recurrent/metastatic cervical cancer and oropharyngeal cancer to be presented at ASCO – –   Company and the Recurrent Respiratory Papillomatosis Foundation to co-sponsor the inaugural RRP Awareness Day on June 11 th to raise awareness and bring together individuals living with RRP, caregivers, clinicians, and government officials – –   Cash, cash equivalents, and short-term investments totaled $44.8 million as of March 31, 2024 – GERMANTOWN, Md. , May 14, 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 first quarter 2024 financial results and business updates.

Precigen Reports First Quarter 2024 Financial Results and Business Updates

GERMANTOWN, Md. , May 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 announced the Company will report first quarter 2024 financial results after the market close on Tuesday, May 14, 2024.

Precigen to Announce First Quarter 2024 Financial Results on May 14th and Host a Conference Call on June 3rd following the Late-breaking Oral Presentation for PRGN-2012 at the 2024 ASCO Annual Meeting

GERMANTOWN, Md. , April 24, 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 clinical data from the pivotal Phase 2 study of PRGN-2012 AdenoVerse immunotherapy for the treatment of patients with recurrent respiratory papillomatosis (RRP) will be presented in a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 31 to June 4, 2024 at McCormick Place in Chicago, Illinois.

Precigen to Present Late-breaking Abstract for Pivotal Phase 2 Study Data for PRGN-2012 AdenoVerse Immunotherapy for the Treatment of Patients with Recurrent Respiratory Papillomatosis at the 2024 ASCO Annual Meeting

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–  Inaugural multi-stakeholder event on June 11th (6/11)  will raise awareness and bring together individuals living with RRP, caregivers, clinicians, and government officials – –   RRP is a rare, HPV-driven disease with no FDA-approved therapeutic – GERMANTOWN, Md. , March 28, 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 has teamed up with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to launch the first RRP Awareness Day™ on June 11, 2024, a multi-stakeholder event to raise awareness about recurrent respiratory papillomatosis (RRP) and bring together RRP patients and their caregivers to encourage new connections and build community among those interested in and affected by this devastating disease.

Precigen and Recurrent Respiratory Papillomatosis Foundation to Hold Inaugural International RRP Awareness Day on June 11th

Precigen, Inc. (PGEN) Q4 2023 Earnings Call Transcript

–   Significant progress made in the development of the PRGN-2012 AdenoVerse immunotherapy for the treatment of RRP; Precigen plans to submit a BLA under an accelerated approval pathway in the second half of 2024; ramping up commercial readiness activities for a potential launch in 2025 – –   Precigen's PRGN-2012 received the first Breakthrough Therapy Designation and accelerated approval pathway from the FDA for the treatment of RRP – –   Precigen received IND clearance for a randomized Phase 2 study of PRGN-2009 AdenoVerse immunotherapy in combination with pembrolizumab in HPV-associated recurrent/metastatic cervical cancer; study now active and recruiting patients – –   Interim data from the ongoing Phase 1b study of PRGN-3006 UltraCAR-T in relapsed/refractory AML anticipated in the second half of 2024 – –   Preliminary data from the Phase 1 study of PRGN-3007 next generation UltraCAR-T in ROR1+ advanced cancers anticipated in the second half of 2024 – –   Cash, cash equivalents, short-term and long-term investments totaled $62.9 million as of December 31, 2023 – –   Continued focus on cost containment resulted in a reduction in SG&A costs of 16% for the twelve months ended December 31, 2023, compared to the prior year period – GERMANTOWN, Md. , March 19, 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 full year 2023 financial results and business updates.

Precigen Reports Full Year 2023 Financial Results and Business Updates

GERMANTOWN, Md. , March 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 that Cantor Fitzgerald will be hosting a virtual fireside chat with Precigen on Monday, March 25, 2024 at 1:00 PM ET to discuss the investigational PRGN-2012 AdenoVerse ™  immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP).

Precigen to Participate in a Fireside Chat Hosted by Cantor Fitzgerald to Discuss PRGN-2012 AdenoVerse Immunotherapy for the Treatment of Recurrent Respiratory Papillomatosis

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