Core Viewpoint - The stock price of Precigen (NASDAQ: PGEN) has remained unchanged at $1.62 over a period of 17 months, indicating a lack of significant movement or development in the company's valuation [1]. Company Analysis - Precigen was rated a HOLD on January 31, 2023, at a price of $1.62, and as of July 3, 2025, the stock price is still $1.62, suggesting stability but potentially stagnation in growth or investor interest [1]. Analyst Background - The analyst has a background in finance, teaching international finance and financial risk management, and has experience in various sectors including biotech and fintech [2].

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 March 31, 2025 OR Table of Contents Commission File Number: 001-36042 PRECIGEN, INC. (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, Maryland 20876 (Address of principal executiv ...

Exhibit 99.1 Precigen Reports First Quarter 2025 Financial Results and Business Updates GERMANTOWN, MD, May 14, 2025 – 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 2025 financial results and business updates. "We are extremely pleased with the progress of our PRGN-2012 program and its immense potential for RRP patients. We remain laser-focused on advancing the p ...

Core Insights - Precigen, Inc. is collaborating with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to co-host the annual RRP Awareness Day on June 11, 2025, aimed at raising awareness about recurrent respiratory papillomatosis (RRP) and fostering community among patients, caregivers, and healthcare professionals [1][3] Company Overview - Precigen, Inc. is a biopharmaceutical company focused on developing innovative gene and cell therapies to improve patient lives, particularly in the areas of immuno-oncology, autoimmune disorders, and infectious diseases [6] - The company operates as an innovation engine, progressing a pipeline of therapies toward clinical proof-of-concept and commercialization [6] Industry Context - RRP is a rare, chronic disease primarily caused by HPV 6/11 infection, affecting approximately 27,000 adults in the US and over 125,000 patients globally [2] - The current standard-of-care for RRP involves repeated surgeries, which do not address the underlying cause and carry significant risks, including the potential for irreversible injury [2][4] - There is a high unmet need for effective treatment options that can address the root cause of RRP and reduce the frequency of surgeries [2][4] Event Details - RRP Awareness Day will feature a live event in Washington DC, including a panel discussion with patients, caregivers, and physicians, and will be broadcast globally [3] - The event aims to highlight the experiences of those living with RRP and the urgent need for new treatment options [3][4] Organizational Goals - The RRPF aims to provide support for families, promote public awareness, and stimulate research for more effective treatments and potential cures for RRP [7] - The organization focuses on networking within the RRP community, including patients, families, medical practitioners, and researchers [7]

Precigen (PGEN) Q4 2024 Earnings Call March 19, 2025 11:43 PM ET Company Participants Steven Harasym - VP & Head of Investor RelationsHelen Sabzevari - President & CEORutul Shah - COOPhil Tennant - Chief Commercial OfficerJason Butler - Managing Director & Biotechnology Equity ResearchCarolina Ibanez Ventoso - Associate Vice PresidentJennifer Kim - Equity Research Director Conference Call Participants Swayampakula Ramakanth - Managing Director & Senior Equity AnalystBrian Cheng - Biotech Analyst Operator Go ...

Precigen, Inc. (NASDAQ:PGEN) Q4 2024 Earnings Conference Call March 19, 2025 4:30 PM ET Company Participants Steven Harasym - IR Helen Sabzevari - President and CEO Rutul Shah - COO Phil Tennant - CCO Harry Thomasian - CFO Conference Call Participants Jason Butler - Citizens Carolina Ibanez Ventoso - Stifel Swayampakula Ramakanth - H.C. Wainwright Jennifer Kim - Cantor Brian Cheng - JPMorgan Operator Good evening, and welcome to the Precigen's Full Year 2024 Financial Results and Business Update Call. At th ...

Financial Performance - Precigen, Inc. reported a quarterly loss of $0.04 per share, better than the Zacks Consensus Estimate of a loss of $0.06, and an improvement from a loss of $0.09 per share a year ago, representing an earnings surprise of 33.33% [1] - The company posted revenues of $1.19 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 2.86%, and down from $1.23 million in the same quarter last year [2] - Over the last four quarters, Precigen has surpassed consensus EPS estimates only once and has not beaten consensus revenue estimates during this period [2] Stock Performance and Outlook - Precigen shares have increased by approximately 49.1% since the beginning of the year, contrasting with a decline of 4.5% in the S&P 500 [3] - The future performance of Precigen's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.06 on revenues of $0.8 million, and for the current fiscal year, it is -$0.20 on revenues of $21.9 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Precigen belongs, is currently ranked in the top 30% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor sentiment and stock performance [5]

Financial Position and Capital Needs - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $97.9 million, raising substantial doubt about its ability to continue as a going concern within one year[201]. - The company has incurred significant losses since inception, with an accumulated deficit of $2.1 billion as of December 31, 2024, and expects to continue incurring losses and negative cash flows for the foreseeable future[207]. - The company raised approximately $30.9 million in net proceeds from an equity offering in August 2024 and approximately $78.5 million in December 2024, indicating ongoing capital needs[210]. - The company may need to raise additional capital through non-dilutive or dilutive financing, which could adversely affect existing shareholders and lead to significant dilution[202]. - The company has a limited number of shares available for future issuance, with 400 million shares authorized and 294,042,973 shares already issued as of February 15, 2025, potentially impacting its ability to raise capital[205]. Strategic Prioritization and Workforce Changes - A strategic prioritization announced on August 6, 2024, included a workforce reduction of over 20%, resulting in non-cash impairment charges of approximately $32.9 million and employee severance costs of $2.1 million[206]. - The company has prioritized the development of PRGN-2012 for the treatment of RRP, minimizing spending on UltraCAR-T and pausing enrollment in PRGN-3005 and PRGN-3007 clinical trials[242]. - The company has shut down its ActoBio subsidiary operations, indicating a strategic shift in resource allocation[243]. - The company has reduced its focus on preclinical programs while continuing select projects that could provide near-term validation of its technology platforms[242]. Regulatory and Clinical Development Challenges - The company is dependent on FDA approval of its BLA for PRGN-2012, which was accepted for priority review in February 2025, with a target action date set for August 27, 2025[201]. - The company’s ability to commercialize its product candidates is contingent on successful clinical trials, regulatory approvals, and the establishment of a commercial organization[213]. - The regulatory approval processes for product candidates are lengthy and unpredictable, potentially harming the business if approvals are not obtained[220]. - The clinical trial requirements and evaluation criteria by regulatory authorities vary significantly, making the approval process for novel product candidates more expensive and time-consuming[222]. - Patient enrollment in clinical trials is critical, and difficulties in recruiting patients could delay or prevent trial progress[232]. - The company has limited experience in designing and implementing clinical trials, which could lead to increased costs and delays in obtaining regulatory approval[231]. - There is a high failure rate for drugs in clinical trials, and negative results could lead to discontinuation of trials or additional studies, adversely affecting business prospects[230]. Market and Competitive Landscape - The market opportunities for the company's product candidates may be smaller than estimated due to reliance on internal estimates and lack of verifiable marketing data[218]. - The prevalence of recurrent respiratory papillomatosis (RRP), the target indication for PRGN-2012, is based on internal estimates and limited research, which may lead to inaccuracies in market opportunity assessments[219]. - The company faces intense competition in the biotechnology sector, with competitors having greater financial and technical resources[296]. - The lead product candidate, PRGN-2012, is based on the AdenoVerse platform for treating RRP, competing with INOVIO Pharmaceuticals' investigational DNA vaccine[297]. - The company is developing PRGN-3006 for AML and PRGN-2009 for cancer, facing competition from multiple established firms in CAR-T therapies[298]. - The company is also pursuing treatments for autoimmune disorders, with competitors like Provention Bio and Midatech Pharma in the T1D space[299]. Financial and Operational Risks - The company anticipates substantial increases in expenses as it advances preclinical and clinical development of its product candidates and prepares for commercialization[208]. - The company faces risks related to macroeconomic conditions, including inflation, interest rates, and geopolitical conflicts, which could impact its ability to raise capital on favorable terms[210]. - The company may incur significant additional expenses due to ongoing regulatory obligations even after obtaining marketing approval[247]. - The company faces uncertainty regarding future drug pricing methodologies under Medicare, which could affect its revenue[265]. - The company incurs significant costs for compliance with environmental, health, and safety laws, which may expose it to substantial liabilities[281]. - The company is subject to extensive regulations, including the Foreign Corrupt Practices Act, which could lead to severe penalties for violations[283]. Intellectual Property and Legal Risks - The company faces risks related to intellectual property, including potential litigation and the need to protect proprietary technologies[321][326]. - The company may face substantial costs and disruptions due to potential patent litigation, which could harm its ability to compete[332]. - The company may not be able to obtain additional patent term extensions under the Hatch-Waxman Amendments, which could adversely affect its revenue generation capabilities[335]. - The company relies on trade secrets and regulatory exclusivity to protect some products, but these protections may not be sufficient against competition[336]. - The company has entered into complex licensing agreements, and disputes may arise that could impair its ability to develop and commercialize product candidates[339]. - The company faces challenges in enforcing its intellectual property rights globally, particularly in jurisdictions with weaker protections[342]. Stock Performance and Corporate Governance - The company received a deficiency letter from Nasdaq on November 1, 2024, indicating that the bid price for its common stock had closed below the minimum $1.00 per share requirement for continued listing[346]. - The company was provided an initial period of 180 calendar days, until April 30, 2025, to regain compliance with the minimum bid price requirement[347]. - On January 16, 2025, the company regained compliance with the Bid Price Rule after its common stock closed at or above $1.00 per share for ten consecutive business days[348]. - The company's stock price has fluctuated significantly, trading as high as $2.19 per share and as low as $0.67 per share from January 1, 2023, to February 15, 2025[354]. - As of December 31, 2024, Randal J. Kirk controlled approximately 40% of the company's common stock, which may significantly influence management and operations[362]. - The company does not anticipate paying cash dividends in the future and intends to retain all future earnings to finance operations and growth[360]. - The company is subject to anti-takeover provisions that could delay or prevent beneficial acquisitions[368]. Cybersecurity and Operational Risks - The company has implemented cybersecurity safeguards, but these systems remain vulnerable to breaches, which could adversely affect business operations[306][307]. - The cybersecurity risk management program is integral to the company's overall enterprise risk management processes, with regular updates provided to the board of directors[375]. - The company relies on various information systems to manage operations, and failures in these systems could materially impact financial condition[305]. - Health epidemics, including COVID-19, could adversely affect business operations and financial position due to supply chain disruptions[309][310]. - The company has international operations that may expose it to various economic, social, and governmental risks, including currency fluctuations[313][314]. Compliance and Regulatory Environment - Compliance with healthcare laws and regulations is costly and may expose the company to significant penalties if found in violation[274]. - The company must navigate complex data protection laws, including the GDPR, which could impose additional operational restrictions and costs[277]. - The U.S. and foreign data protection regulations may require the company to take on more onerous obligations, impacting its ability to operate effectively[280]. - The company is actively monitoring legislative developments that could influence its business operations and pricing strategies[266].

Financial Performance - Total revenues for 2024 decreased by $2.3 million, or 37%, compared to 2023, primarily due to reductions in product and service volumes at Exemplar[11]. - Total revenues for the year ended December 31, 2024, were $3,925,000, a decrease of 37% compared to $6,225,000 in 2023[25]. - Product revenues decreased to $422,000 in 2024 from $840,000 in 2023, representing a decline of 50%[25]. - Service revenues also declined to $3,470,000 in 2024, down from $5,301,000 in 2023, a decrease of 34%[25]. - Net loss for 2024 was $126.2 million, or $(0.47) per share, compared to a net loss of $95.9 million, or $(0.39) per share, in 2023[18]. - The net loss for the year ended December 31, 2024, was $126,235,000, compared to a net loss of $95,904,000 in 2023, reflecting an increase in losses of 31%[25]. - Net loss per share, basic and diluted, was $0.47 in 2024, compared to $0.39 in 2023[25]. - The weighted average shares outstanding increased to 267,727,426 in 2024 from 244,536,221 in 2023[25]. Research and Development - Research and development expenses increased by $4.5 million, or 9%, mainly due to costs associated with the initiation of the PRGN-2012 confirmatory clinical trial and increased drug manufacturing material costs[12]. - Research and development expenses rose to $53,070,000 in 2024, compared to $48,614,000 in 2023, an increase of 9%[25]. Cash and Investments - The company ended 2024 with $97.9 million in cash, cash equivalents, and investments, extending its cash runway into 2026[5]. FDA and Market Opportunity - The FDA granted priority review to the BLA for PRGN-2012, with a PDUFA target action date set for August 27, 2025, potentially allowing for the first FDA-approved treatment for approximately 27,000 adult RRP patients in the US[6]. - The market opportunity for PRGN-2012 in RRP is estimated to be approximately 27,000 adult patients in the US and over 125,000 patients outside the US[13]. Impairment and Other Income - The company recorded a $5.8 million impairment charge in Q4 2024 related to its Exemplar subsidiary, along with $34.5 million of impairment charges in Q2 2024 due to the suspension of ActoBio's operations[16]. - Total other income increased by $3.6 million, or 106%, compared to 2023, primarily due to an $8.5 million gain on the sale of intellectual property rights[17]. - Other income, net, increased significantly to $7,001,000 in 2024 from $3,396,000 in 2023, an increase of 106%[25]. - Impairment of other noncurrent assets rose sharply to $32,915,000 in 2024 from $445,000 in 2023[25]. Operating Expenses - Total operating expenses increased to $138,954,000 in 2024, up 31% from $105,983,000 in 2023[25]. - SG&A expenses increased by $0.9 million, or 2%, due to increased focus on PRGN-2012 and associated commercial readiness costs[15].

Core Insights - Precigen, Inc. announced its full year 2024 financial results and business updates, highlighting significant progress in its PRGN-2012 therapy for recurrent respiratory papillomatosis (RRP) and a strengthened financial position for potential commercialization in 2025 [1][2]. Financial Performance - Total revenues for 2024 decreased by $2.3 million, or 37%, compared to 2023, primarily due to reduced product and service volumes at Exemplar [8]. - Research and development expenses increased by $4.5 million, or 9%, mainly due to costs associated with the initiation of the PRGN-2012 confirmatory clinical trial and increased drug manufacturing material costs [9]. - The company recorded a net loss of $126.2 million, or $(0.47) per share, compared to a net loss of $95.9 million, or $(0.39) per share in 2023 [15][22]. Key Developments - The FDA granted priority review to the BLA for PRGN-2012, with a target action date set for August 27, 2025, which could lead to the first FDA-approved treatment for approximately 27,000 adult RRP patients in the US [4][5]. - Results from the pivotal clinical study of PRGN-2012 showed that 51% of patients achieved complete responses, with some remaining surgery-free beyond three years [5][4]. - The company ended 2024 with $97.9 million in cash and equivalents, extending its cash runway into 2026, beyond the potential commercial launch of PRGN-2012 [4][14]. Product Pipeline - PRGN-2012 is an investigational gene therapy designed to target HPV 6 and 11 infections in RRP patients, having received Breakthrough Therapy and Orphan Drug Designations from the FDA [3]. - The company is also advancing PRGN-2009 for HPV-associated cancers and PRGN-3006 for acute myeloid leukemia (AML) [6][7]. Market Opportunity - The market opportunity for PRGN-2012 in RRP is estimated at approximately 27,000 adult patients in the US and over 125,000 patients outside the US [13].