Welcome to our dedicated page for Precision Biosciences news (Ticker: DTIL), a resource for investors and traders seeking the latest updates and insights on Precision Biosciences stock.
Overview
Precision Biosciences, Inc. (DTIL) is a biotechnology firm headquartered in Durham, North Carolina, that specializes in genome editing technologies. At its core, the company focuses on revolutionizing the treatment of human diseases while also addressing challenges in food and agriculture. The company harnesses its proprietary ARCUS genome editing platform, employing advanced gene editing techniques that differentiate it from traditional methods. Key industry keywords such as genome editing, gene therapy, and biotechnological innovation underscore its foundational commitment to science and therapeutic development.
The ARCUS Genome Editing Platform
The ARCUS platform is the cornerstone of Precision Biosciences' technology. This innovative system is based on a unique enzyme that is both compact and versatile. Its small size permits efficient delivery using both viral and non-viral gene delivery methods, allowing it to access a broad spectrum of cells and tissues. This flexibility not only enhances the precision of the genome editing process but also minimizes potential off-target effects, making the platform a promising alternative to conventional gene editing tools. Moreover, the ARCUS platform is engineered to address complex genetic disorders and provide novel pathways for therapeutic intervention.
Applications & Pipeline
Precision Biosciences strategically applies its expertise in genome editing to multiple dimensions of healthcare and agriculture. In the therapeutic realm, the company is developing a diversified pipeline of product candidates aimed at treating complex human diseases. The focus on precision and efficiency in gene editing allows for the potential correction of genetic anomalies that underlie many serious conditions. Beyond human therapeutics, the ARCUS platform has been explored as a tool in the agricultural sector, offering solutions that may lead to improved crop resilience and productivity. This dual application underscores the company’s broad technological impact and its commitment to addressing global challenges in both health and food security.
Competitive Landscape & Differentiators
In a market that includes several players in the genome editing arena, Precision Biosciences differentiates itself through the unique characteristics of its ARCUS platform. Unlike traditional gene editing systems, the ARCUS enzyme's reduced size allows for a more comprehensive range of cellular targets and a potentially safer profile when integrated into gene therapy applications. The company’s comprehensive approach, which integrates discovery, development, and application, positions it distinctly in a competitive landscape where precision and adaptability are critical for success.
Operational Strategy & Research Excellence
Precision Biosciences operates under a model of continuous innovation and rigorous scientific inquiry. The company’s R&D efforts are deeply rooted in understanding the delicate nuances of genomic medicine and the technical challenges associated with effective gene editing. By leveraging both in-house talent and strategic academic collaborations, the company remains at the forefront of technological advances. Investment in versatile delivery methodologies further enhances the ARCUS system, with researchers constantly working to expand its capabilities in editing precision and efficacy. The blend of scientific rigor and operational agility is apparent in the company’s methodical approach to addressing core biological challenges.
Market Position & Industry Impact
Precision Biosciences occupies a notable niche within the biotechnology sector. Its emphasis on genome editing not only contributes to advancements in targeted therapeutics but also establishes a framework for potential revolutionary changes in agriculture. By integrating robust scientific research with scalable technological applications, the company fosters an environment where complex genetic challenges can be mitigated. The ARCUS platform, with its innovative design, is central to the company’s vision of harnessing precise genetic modifications to drive efficiency in both healthcare and agricultural production. The comprehensive approach taken by Precision Biosciences helps demystify the often intricate subject of gene editing and makes it accessible to a broader audience including investors and scientific peers.
Intellectual Property & Technological Edge
A critical factor underpinning the company's success is its strong portfolio of intellectual property associated with the ARCUS platform. This collection of patents and proprietary methodologies provides a competitive mooring that shields the company’s innovations and fosters a secure environment for future collaborative efforts within the industry. By investing heavily in the protection and expansion of its technological assets, Precision Biosciences reinforces its expertise and demonstrates an unwavering commitment to advancing genome editing science responsibly and effectively.
Global Collaborations & Industry Partnerships
Recognizing the value of strategic alliances, Precision Biosciences engages in numerous collaborations with academic institutions, research centers, and industry partners. These partnerships play an essential role in validating the ARCUS platform’s efficacy and expanding its application across diverse fields. Such cooperative efforts not only accelerate innovation but also help integrate the company’s technological advancements into broader scientific efforts around the world. This interconnected approach underlines the company’s commitment to transparency and the pursuit of excellence in scientific discovery, embodying a holistic view that benefits both the research community and end users.
Scientific Rigor & Regulatory Considerations
Operating in a highly regulated industry, Precision Biosciences emphasizes scientific rigor and a cautious approach to translating laboratory innovations into viable therapeutic solutions. The company upholds stringent quality controls and comprehensive validation processes that help ensure the safety and effectiveness of its genome editing interventions. By adhering to established regulatory frameworks and continuously refining its methodologies, the company reinforces its position as a scientifically sound enterprise. This detailed, methodical approach is integral to earning the confidence of both the scientific community and regulatory bodies.
Conclusion
In summary, Precision Biosciences, Inc. stands out as a formidable entity in the biotechnology sector through its innovative ARCUS genome editing platform. The company’s versatile technology, coupled with its expansive application in both healthcare and agriculture, forms the backbone of a distribution model that is thoughtful and scientifically rigorous. By continuously pushing the frontiers of gene editing, the company demonstrates a robust grasp of future challenges and solutions in genomic medicine and agricultural innovation. Investors and industry observers view Precision Biosciences as a compelling case study in how focused technical innovations, when coupled with a comprehensive business strategy, can effect meaningful change in addressing genetic disorders and global food security issues. The commitment to research excellence, coupled with strategic collaborations and a deep understanding of market dynamics, makes the company a noteworthy player in the evolving landscape of gene editing and biotechnology.
Precision BioSciences (NASDAQ: DTIL) reported significant clinical progress in Q4 and FY2024, highlighting two successful in vivo gene editing programs. The company's lead program PBGENE-HBV, targeting Hepatitis B, demonstrated safety and substantial antiviral activity in initial trials. The first patient cohort showed HBsAg reduction in two of three patients at the lowest dose level.
Their partner iECURE reported a complete clinical response in the first infant treated for Ornithine Transcarbamylase Deficiency. The company received IND and CTA approvals for ELIMINATE-B trials across multiple countries, including the US.
Financial highlights include $108.5M in cash and equivalents as of December 31, 2024, with runway extended into H2 2026. Q4 revenues were $0.6M compared to $7.0M in Q4 2023. Net loss increased to $17.8M from $13.4M year-over-year.
iECURE presented encouraging data from its OTC-HOPE Phase 1/2 clinical trial of ECUR-506 for ornithine transcarbamylase (OTC) deficiency at the 2025 ACMG Annual Clinical Genetics Meeting. The first infant patient, dosed at 6.5 months old with 1.3 x 1013 GC/kg of ECUR-506, showed promising results after six months of treatment.
Key findings include:
- Complete clinical response achieved per study protocol
- Successful discontinuation of ammonia scavenger medication at 12 weeks post-treatment
- Increased protein allowance to age-appropriate levels
- Higher blood urea nitrogen (BUN) levels post-treatment, suggesting improved OTC enzyme function
- Normal plasma ammonia levels maintained after medication removal
While treatment was generally well-tolerated, a temporary Grade 3 transaminitis was observed at four weeks post-exposure, which resolved by week eight with immunosuppressive therapy.
Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company, has announced it will release its fourth quarter and fiscal year 2024 financial results on March 26, 2025. The company, which develops in vivo gene editing therapies using its proprietary ARCUS® platform, will also provide a business update. Their platform technology focuses on gene elimination, gene insertion, and gene excision programs.
Precision BioSciences (NASDAQ: DTIL) presented preclinical data for PBGENE-HBV, the first clinical-stage gene editing therapy for chronic hepatitis B, at the Global Hepatitis Summit 2025. The data supports repeat dosing in the ongoing ELIMINATE-B Phase 1 trial.
Key findings show that in non-human primates, repeated PBGENE-HBV administration was safe and well-tolerated, with no systemic accumulation. Previous data demonstrated up to 99% viral eradication with two doses. Initial results from cohort 1 showed the first 0.2 mg/kg dose was safe, with substantial HBsAg reduction in two of three participants.
The ELIMINATE-B study is actively enrolling HBeAg-negative chronic Hepatitis B patients in Moldova, Hong Kong, and New Zealand, with planned expansion to U.S. sites. The trial will evaluate up to three dose administrations at each dose level, with the company planning to share detailed clinical data throughout 2025.
Precision BioSciences (DTIL) presented preclinical data for PBGENE-DMD, a novel gene editing therapy for Duchenne muscular dystrophy (DMD) at the 2025 MDA Conference. The therapy uses ARCUS® platform to excise exons 45-55 of the dystrophin gene, potentially benefiting up to 60% of DMD patients.
Key findings from the preclinical study in humanized DMD mouse models showed:
- Restoration of functional dystrophin protein across multiple muscles including heart, diaphragm, and skeletal muscles
- 66% improvement in muscle resilience against eccentric injury
- Maximum force output reaching 93% of healthy control mice, with improvements observed between 3-6 months
- Evidence of dystrophin gene correction in muscle satellite stem cells, suggesting potential long-term therapeutic benefits
Precision BioSciences (NASDAQ: DTIL) has received FDA clearance for its Investigational New Drug (IND) application for PBGENE-HBV, marking a significant milestone as the first-ever in vivo gene editing therapy cleared for clinical trials in treating chronic hepatitis B in the United States.
The company will expand its Phase 1 ELIMINATE-B study to the U.S., specifically at the Liver Center at Massachusetts General Hospital, adding to existing trial sites in Moldova, Hong Kong, and New Zealand. The trial's first cohort is currently receiving doses at 0.2 mg/kg, with plans to escalate to a higher dose level in Cohort 2.
PBGENE-HBV, developed using Precision's proprietary ARCUS® platform, aims to cure chronic hepatitis B by eliminating cccDNA and inactivating integrated HBV DNA in hepatocytes. The company plans to expand the study to the UK and will share detailed clinical data throughout 2025. The development addresses a significant medical need, as up to 2.4 million people in the U.S. live with chronic hepatitis B, with numbers remaining largely unchanged over the past 15 years despite existing treatments.
iECURE announced it will present initial data from its Phase 1/2 OTC-HOPE clinical trial for ECUR-506, an in vivo gene editing treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency, at the 2025 ACMG Annual Clinical Genetics Meeting in Los Angeles.
The presentation will expand on previously reported data from January 2025, which showed that the first infant treated in the trial achieved a complete clinical response according to study protocol. Dr. Julien Baruteau from Great Ormond Street Hospital for Children, London, will present the findings on March 21, 2025.
Precision BioSciences (NASDAQ: DTIL) has announced an upcoming oral presentation of preclinical data from their PBGENE-DMD program at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference. The presentation, scheduled for March 19, 2025, at 8:00 AM CT, will focus on the treatment of Duchenne muscular dystrophy (DMD) using their proprietary ARCUS® platform.
The presentation will detail how ARCUS-mediated excision of exons 45-55 leads to functional Del45-55 dystrophin and restoration of skeletal muscle function in DMD treatment. The company's ARCUS platform is being developed for various in vivo gene editing therapies, including gene elimination, insertion, and excision programs.
Precision BioSciences (NASDAQ: DTIL) announced initial results from the ELIMINATE-B Phase 1 trial of PBGENE-HBV, their novel gene editing therapy for chronic Hepatitis B. The first cohort of three patients received the lowest dose level (0.2 mg/kg) of PBGENE-HBV, which uses ARCUS-encoding mRNA in lipid nanoparticles.
Key findings include:
- The treatment was safe and well-tolerated with no Grade ≥2 treatment-related adverse events
- Two of three participants showed substantial reduction in Hepatitis B surface antigen (HBsAg)
- The trial is designed for three dose administrations per dose level
The study is currently enrolling HBeAg-negative chronic Hepatitis B patients in Moldova, Hong Kong, and New Zealand, with plans to expand to the U.S. and U.K. Precision plans to share detailed clinical data throughout 2025.
Precision BioSciences (NASDAQ: DTIL) announced key leadership changes to strengthen its in vivo gene editing programs. Cindy Atwell has been promoted to Chief Development and Business Officer, overseeing development functions including clinical, regulatory, and business development. She will supervise the PBGENE-HBV program and future in vivo initiatives.
Dr. Cassie Gorsuch has been elevated to Chief Scientific Officer, leading non-clinical development and gene therapy discovery. She will manage preclinical proof of concept and IND-enabling data for clinical studies advancement. The company's PBGENE-HBV program remains on schedule with Phase 1 clinical data expected in 2025.
Additionally, Dr. Sam Wadsworth has retired from his Director role on the company's Board.
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