Precigen(PGEN)
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Precigen(PGEN) - 2025 Q1 - Quarterly Results
2025-05-14 20:19
[Business and Financial Highlights](index=1&type=section&id=Business%20and%20Financial%20Highlights) Precigen advanced PRGN-2012 for RRP with FDA priority review (PDUFA August 2025), ending Q1 2025 with $81 million cash, funding operations into 2026 - The company is highly focused on advancing PRGN-2012, which could become the first FDA-approved therapeutic for RRP, with a PDUFA target action date of **August 27, 2025**[3](index=3&type=chunk)[6](index=6&type=chunk) - Precigen and the Recurrent Respiratory Papillomatosis Foundation will host the 2025 International RRP Awareness Day on June 11 to engage with patients, caregivers, and the healthcare community[3](index=3&type=chunk)[4](index=4&type=chunk) Financial Position | Financial Position | Amount ($) | Note | | :--- | :--- | :--- | | Cash, cash equivalents, and investments | $81.0 million | As of March 31, 2025 | | Cash Runway Expectation | Into 2026 | Excludes potential PRGN-2012 revenue | [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Precigen's clinical pipeline is led by PRGN-2012 nearing FDA approval, with other candidates like PRGN-2009 and PRGN-3006 also advancing [PRGN-2012 AdenoVerse Gene Therapy in RRP](index=1&type=section&id=PRGN-2012%20AdenoVerse%20Gene%20Therapy%20in%20RRP) PRGN-2012, an RRP gene therapy, is under FDA priority review (PDUFA August 2025), showing 51% complete response in pivotal study, with 2025 commercial launch preparations underway - The FDA accepted the BLA for PRGN-2012, granted priority review, and set a PDUFA target action date for **August 27, 2025** An advisory committee meeting is not currently planned[6](index=6&type=chunk)[7](index=7&type=chunk) - Pivotal study results showed **51%** of patients (18 of 35) achieved a Complete Response, requiring no surgeries after treatment, with durable responses observed for up to three years[7](index=7&type=chunk)[8](index=8&type=chunk) - **86%** of patients (30 of 35) experienced a decrease in surgical interventions post-treatment, with median surgeries dropping from 4 to 0[15](index=15&type=chunk) - Commercial and manufacturing readiness campaigns are advancing in anticipation of a potential **2025** launch, supported by commercialization partner EVERSANA[6](index=6&type=chunk)[15](index=15&type=chunk) [PRGN-2009 AdenoVerse Gene Therapy in HPV-associated Cancers](index=3&type=section&id=PRGN-2009%20AdenoVerse%20Gene%20Therapy%20in%20HPV-associated%20Cancers) PRGN-2009, an investigational gene therapy for HPV-associated cancers, is undergoing Phase 2 clinical trials in partnership with the NCI - Phase 2 clinical trials are ongoing for recurrent/metastatic cervical cancer and newly diagnosed HPV-associated oropharyngeal cancer in partnership with the NCI[9](index=9&type=chunk) [PRGN-3006 UltraCAR-T in AML and MDS](index=3&type=section&id=PRGN-3006%20UltraCAR-T%20in%20AML%20and%20MDS) PRGN-3006, an autologous CAR-T therapy for AML and MDS, has completed Phase 1b enrollment for AML and received FDA Orphan Drug and Fast Track designations - The company has completed patient enrollment in the Phase 1b trial for PRGN-3006 in AML[10](index=10&type=chunk) - PRGN-3006 has been granted Orphan Drug Designation for AML and Fast Track Designation for relapsed/refractory (r/r) AML by the FDA[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) Precigen's Q1 2025 revenues rose 26% to $1.3 million, while R&D decreased 27% and SG&A increased 22%, resulting in a $54.2 million net loss primarily due to warrant liabilities Financial Performance Summary | Metric | Q1 2025 ($) | Q1 2024 ($) | Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $1.3M | $1.1M | +26% | Increased volume at Exemplar | | R&D Expenses | $10.5M | $14.2M | -27% | Closure of ActoBio operations and asset prioritization | | SG&A Expenses | $12.4M | $10.2M | +22% | PRGN-2012 commercial readiness activities | | Net Loss | $54.2M | $23.7M | +129% | Primarily a $32.5M non-cash change in fair value of warrant liabilities | | Net Loss Per Share | $(0.18) | $(0.10) | +80% | Increased net loss and higher share count | - Total other expense was **$31.6 million**, a significant shift from an income of **$0.6 million** in Q1 2024 This was driven by a **$32.5 million** non-cash increase in the fair value of warrant liabilities due to a higher stock price[14](index=14&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) Precigen's unaudited consolidated financial statements for Q1 2025 show total assets of $128.8 million, total liabilities of $113.3 million, and a net loss of $54.2 million [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Precigen's balance sheet as of March 31, 2025, shows total assets of $128.8 million and total liabilities of $113.3 million, driven by increased warrant liabilities Balance Sheet Summary | (Amounts in thousands) | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $6,058 | $29,517 | | Short-term investments | $74,184 | $68,393 | | **Total Assets** | **$128,787** | **$145,266** | | **Liabilities & Equity** | | | | Warrant liabilities | $83,018 | $50,537 | | **Total Liabilities** | **$113,329** | **$78,535** | | Total shareholders' (deficit) equity | $(14,060) | $38,513 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Precigen's Q1 2025 statement of operations shows $1.34 million in revenues, a $22.6 million operating loss, and a $54.2 million net loss due to warrant liabilities Statements of Operations Summary | (Amounts in thousands, except per share data) | Three Months Ended March 31, 2025 ($) | Three Months Ended March 31, 2024 ($) | | :--- | :--- | :--- | | Total revenues | $1,341 | $1,065 | | Total operating expenses | $23,937 | $25,475 | | Operating loss | $(22,596) | $(24,410) | | Change in fair value of warrant liabilities | $(32,481) | $— | | **Net loss** | **$(54,153)** | **$(23,738)** | | Net loss per share, basic and diluted | $(0.18) | $(0.10) |
Precigen and Recurrent Respiratory Papillomatosis Foundation to Host the 2025 International RRP Awareness Day on June 11th
Prnewswire· 2025-04-16 12:05
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) - 2024 Q4 - Earnings Call Transcript
2025-03-20 03:43
Financial Data and Key Metrics Changes - The company reported a net loss of $126.2 million or $0.47 per basic and diluted share for the year 2024, compared to a net loss of $95.9 million or $0.39 per basic and diluted share in 2023, indicating a significant increase in losses [8]. Business Line Data and Key Metrics Changes - The company is on the verge of commercializing its lead asset, PRGN 2012, with a BLA submission completed and FDA acceptance with priority review, targeting a PDUFA date of August 27, 2025 [3][5]. Market Data and Key Metrics Changes - The company anticipates a concentration of patients in urban academic centers and large integrated delivery networks (IDNs), with an initial target of 500 fellowship-trained otolaryngologists responsible for treating the majority of patients [12][28]. Company Strategy and Development Direction - The company is transitioning from a research and development focus to a commercial organization, prioritizing the launch of PRGN 2012 while also advancing other programs like PRGN 2009 targeting HPV-related cancers [7][3]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming commercialization of PRGN 2012, highlighting the unmet need in the patient population and the importance of their treatment prior to irreversible damage from surgeries [30][34]. Other Important Information - The company has established an in-house GMP facility for adenovirus drug substance manufacturing, which has been operational since 2019, ensuring control over manufacturing activities [4]. Q&A Session Summary Question: Update on BLA submission and FDA interactions - Management confirmed close alignment with the FDA during the BLA submission process and expressed gratitude for the guidance received [11]. Question: Size of the field force and market capture - The company plans to deploy a modest sales team of 15 to 20 representatives, targeting urban centers where the majority of patients are located [12]. Question: Timing of additional FDA meetings and inspections - Management indicated that pre-approval inspections are anticipated but could not provide specific timing details [27]. Question: Patient identification and confirmatory trial status - The confirmatory trial for PRGN 2012 has been initiated, with patient enrollment ongoing, but data will not be available by the PDUFA date [21][22]. Question: Pricing and payer access discussions - The company continues to engage with payers, emphasizing the value proposition of their treatment and the recognition of the unmet need in the market [29][34].
Precigen(PGEN) - 2024 Q4 - Earnings Call Transcript
2025-03-19 23:47
Financial Data and Key Metrics Changes - The company reported a net loss of $126.2 million for 2024, compared to a net loss of $95.9 million in 2023, representing an increase in loss per share from $0.39 to $0.47 [36][41] - Cash burn for 2024 totaled $76.8 million, which includes cash used in operations and capital expenditures [36][41] - The company raised $79 million through a preferred stock issuance at the end of 2024, which included warrants for common stock [38][40] Business Line Data and Key Metrics Changes - The lead asset, PRGN-2012, has shown a 51% complete response rate in pivotal clinical trials, with a median durability of response at 24 months [9][10] - The confirmatory trial for PRGN-2012 has been initiated, with 35 patients to be enrolled, and is designed in alignment with FDA requirements [13][70] Market Data and Key Metrics Changes - The estimated number of adult patients with RRP in the US is now believed to be up to 27,000, higher than previous estimates of 20,000, indicating a greater unmet need [22][61] - The company anticipates commercial revenues from PRGN-2012 to begin in the second half of 2025 [23][41] Company Strategy and Development Direction - The company is transitioning from R&D to commercialization, focusing on the launch of PRGN-2012 as the first and only medical treatment for RRP [24][35] - The commercialization strategy includes a partnership with EVERSANA to support the US launch, emphasizing a patient-centric approach [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing interactions with the FDA regarding the BLA submission and the priority review process [46][48] - There is an expectation of pent-up demand for PRGN-2012, as patients have had limited treatment options historically [56][57] Other Important Information - The company has made significant investments in GMP manufacturing capabilities to support the commercial launch of PRGN-2012 [16][17] - The UltraCAR-T platform is advancing, with ongoing discussions with the FDA regarding pivotal Phase 2 studies [32][34] Q&A Session Summary Question: Update on FDA interactions and commercial launch plans - Management confirmed close interactions with the FDA regarding the BLA submission and characterized the ongoing review positively [46][48] Question: Timing of additional FDA meetings and inspections - Management indicated that pre-approval inspections are anticipated but could not comment on specific timing [54][78] Question: Anticipated patient demand and treatment access - Management acknowledged expected pent-up demand for PRGN-2012 and plans to deploy efforts to ensure timely access for patients [56][57] Question: Status of the confirmatory trial for PRGN-2012 - Management confirmed that the confirmatory trial has been initiated and is expected to take 12 months to complete [70] Question: Pricing and payer access expectations - Management discussed ongoing discussions with payers, indicating a focus on value-based pricing and the importance of the drug's clinical value [96][100]
Precigen, Inc. (PGEN) Reports Q4 Loss, Lags Revenue Estimates
ZACKS· 2025-03-19 23:25
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]
Precigen(PGEN) - 2024 Q4 - Annual Report
2025-03-19 20:30
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].
Precigen(PGEN) - 2024 Q4 - Annual Results
2025-03-19 20:22
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].
Precigen Reports Full Year 2024 Financial Results and Business Updates
Prnewswire· 2025-03-19 20:05
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].
Precigen to Announce Full Year 2024 Financial Results and Provide Business Updates on March 19th
Prnewswire· 2025-03-13 12:05
Group 1 - Precigen, Inc. will release its full year 2024 financial results and provide business updates on March 19, 2025 [1] - A conference call to discuss the results will be held on the same day at 4:30 PM ET [1] - The conference call can be accessed via specific phone numbers for North America and international participants [2] Group 2 - Precigen is a biopharmaceutical company focused on developing innovative gene and cell therapies targeting serious diseases in immuno-oncology, autoimmune disorders, and infectious diseases [3] - The company operates a preclinical and clinical pipeline aimed at achieving clinical proof-of-concept and commercialization of its therapies [3]
Precigen: UltraCAR-T Development Brings Another Side Of Pipeline Advancement
Seeking Alpha· 2025-02-28 13:56
Group 1 - The article discusses the investment opportunities in the biotechnology sector, particularly focusing on Precigen (NASDAQ: PGEN) and its AdenoVerse Technology Platform [2] - The author operates the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and a model portfolio of small and mid-cap stocks [2] - The service includes over 600 biotech investing articles and aims to assist healthcare investors in making informed decisions [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Precigen or the biotechnology sector [1][3][4]