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Core Viewpoint - Precision BioSciences is conducting an investor update focused on its PBGENE-DMD program, which targets Duchenne Muscular Dystrophy (DMD) [2]. Group 1: Company Overview - Naresh Tanna serves as the Chief of Staff and Head of Investor Relations at Precision BioSciences, leading the investor update [2]. - The management team includes Alex Kelly, Chief Financial Officer, and Dr. Cassie Gorsuch, Chief Scientific Officer, indicating a strong leadership presence [2]. Group 2: Key Participants - The update features contributions from notable figures in the DMD community, including Pat Furlong, Founder of Parent Project Muscular Dystrophy (PPMD), highlighting the company's engagement with advocacy organizations [2]. - Dr. Veerapandiyan, a leading DMD investigator and pediatric neurologist from Arkansas Children's Hospital, is also participating, emphasizing the collaboration with medical experts [3]. Group 3: Forward-Looking Statements - The company has indicated that remarks during the update may contain forward-looking statements based on current expectations, with a caution that actual results could differ materially [3].

Core Insights - Precision BioSciences Inc. reported adjusted earnings of $0.36 per share, significantly surpassing the Zacks Consensus Estimate of a -$0.21 loss per share, marking an earnings surprise of +271.43% and a notable improvement from the adjusted loss of $3.2 per share in the same quarter last year [1][2] - The company's revenue for the quarter ended December 31, 2025, was $34.2 million, exceeding the Zacks Consensus Estimate by 178.08%, and reflecting a dramatic increase from $0.6 million in the prior-year quarter, primarily driven by collaboration-related payments [2][3] - Precision BioSciences operates in the Zacks Medical - Biomedical and Genetics industry and announced its Q4 and fiscal year 2025 financial results on March 12, 2026 [3] Market Performance - On March 13, 2026, Jefferies set a price target of $19 for DTIL, lowered from a prior $21, while maintaining a positive outlook, indicating a potential upside of approximately 235% from the stock's trading price of $5.67 [4] - The company's market capitalization is approximately $130 million, with a trading volume of 277,693 shares on March 13, 2026, and the stock has ranged from a low of $3.53 to a high of $8.82 over the past year [5] Clinical Developments - Precision BioSciences has made significant clinical progress with its PBGENE-HBV program for chronic hepatitis B, presenting late-breaking Phase 1 data from the ELIMINATE-B trial, demonstrating safety, tolerability, and antiviral activity [6] - The CEO highlighted these advancements as positioning the company for continued success in 2026 and beyond, supported by an extended cash runway through 2028 following the strong quarterly results [7]

分组1 - Precision BioSciences reported quarterly earnings of $0.36 per share, exceeding the Zacks Consensus Estimate of a loss of $0.21 per share, compared to a loss of $3.2 per share a year ago, representing an earnings surprise of +271.43% [1] - The company posted revenues of $34.2 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 178.08%, compared to year-ago revenues of $0.64 million [2] - Precision BioSciences shares have increased by approximately 21.6% since the beginning of the year, while the S&P 500 has declined by 1% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.82 on revenues of $4.3 million, and for the current fiscal year, it is -$2.07 on revenues of $31.4 million [7] - The Medical - Biomedical and Genetics industry, to which Precision BioSciences belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Gene Editing Technologies - The ARCUS platform is a novel gene editing technology that enables sophisticated gene edits, including insertion, elimination, and excision, with a focus on effective and safe therapeutic outcomes [21]. - PBGENE-HBV is a first-in-human clinical trial aimed at potentially curing chronic hepatitis B by eliminating covalently closed circular DNA (cccDNA) and inactivating integrated hepatitis B virus DNA [30]. - PBGENE-DMD targets Duchenne muscular dystrophy (DMD) and aims to improve function for approximately 60% of patients by excising specific exons of the dystrophin gene [34]. - iECURE-OTC is a partnered program evaluating a targeted gene insertion approach for neonatal onset ornithine transcarbamylase deficiency, with clinical results expected in early 2026 [37]. Clinical Trials and Studies - The Phase 1/2a ELIMINATE-B trial for PBGENE-HBV is enrolling patients across multiple countries, including Hong Kong, New Zealand, the U.S., and Moldova, with plans to expand to the U.K. [30]. - Initial data from the FUNCTION-DMD study for PBGENE-DMD is expected by the end of 2026, focusing on safety and early efficacy through muscle biopsies [34]. Intellectual Property and Patents - The company owns 46 issued U.S. patents and 51 pending non-provisional U.S. patent applications as of December 31, 2024 [60]. - The company relies on a combination of patents and trade secret protection to safeguard its intellectual property related to proprietary technologies [57]. - The company intends to pursue additional patent protection related to ARCUS and existing delivery technologies through licenses from third parties [60]. - The company has pending PCT international applications and multiple pending patent applications in the United States and other countries related to engineered meganucleases targeting the hepatitis B virus, with a potential patent expiration date of November 8, 2044 [72]. Licensing Agreements - A license agreement with Caribou Biosciences was established in February 2024, providing an upfront payment and future royalties on net sales of licensed products [40]. - The Novartis Agreement was terminated effective January 30, 2026, reverting all licenses back to the company without future obligations or payments from Novartis [44]. - The Duke License requires total milestone payments of $0.3 million, with portions paid upon Series A financing and first signed partnership exceeding $1 million [48]. Regulatory Environment - The FDA's goal is to review standard applications within 10 months and priority reviews within 6 months after acceptance for filing [136]. - Orphan drug designation is granted for diseases affecting fewer than 200,000 individuals in the U.S. or when development costs cannot be recovered [147]. - The FDA may require post-market studies to monitor safety and effectiveness after commercialization [139]. - Fast track designation allows for more frequent interactions with the FDA and rolling review of applications [141]. Market and Pricing Challenges - There is substantial uncertainty regarding coverage and reimbursement for newly approved therapeutics, impacting sales potential [200]. - In the EU, governments control pricing and reimbursement levels for pharmaceutical products, creating high barriers for new product entry [201]. - The Inflation Reduction Act of 2022 requires drug manufacturers to negotiate prices with Medicare, which may significantly impact the pharmaceutical industry [205]. Workforce and Company Culture - The company has 68 full-time employees, with 46 engaged in research and development activities and 19 holding Ph.D. degrees [215]. - As of December 31, 2025, the workforce is approximately 47% female and 19% from diverse racial backgrounds [213]. - The company is committed to fostering a diverse and inclusive workplace culture to attract and retain top talent in genome editing [212].

Core Insights - The article discusses the recent financial performance of a leading technology company, highlighting a significant increase in revenue and net income compared to the previous year [1] Financial Performance - The company reported a revenue of $50 billion for the last quarter, representing a 20% increase year-over-year [1] - Net income reached $10 billion, which is a 25% increase compared to the same quarter last year [1] - Earnings per share (EPS) rose to $5, up from $4 in the previous year, indicating strong profitability [1] Market Position - The company has strengthened its market position, capturing an additional 5% market share in the technology sector [1] - Increased demand for its products and services has been attributed to the rise in remote work and digital transformation trends [1] Future Outlook - Analysts predict continued growth, with revenue expected to reach $60 billion in the next fiscal year, driven by new product launches and expansion into emerging markets [1] - The company plans to invest $2 billion in research and development to enhance its product offerings and maintain competitive advantage [1]

Core Insights - Precision BioSciences has received two Notices of Allowance from the U.S. Patent and Trademark Office for its PBGENE-HBV program, which focuses on gene editing therapies for Hepatitis B [1] - The first patent application covers engineered meganucleases targeting the Hepatitis B virus genome, while the second application pertains to polypeptide linkers used in these engineered nucleases [1] - The patents, once granted, are expected to provide composition-of-matter protection for the PBGENE-HBV ARCUS nuclease until at least November 2044, enhancing the company's intellectual property portfolio [1] Company Overview - Precision BioSciences is a clinical stage gene editing company utilizing its proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet needs [1] - The PBGENE-HBV program is currently in a global first-in-human clinical trial aimed at providing a potentially curative treatment for chronic Hepatitis B infection [1] - The program has received Fast Track designation from the FDA, indicating its potential significance in addressing chronic Hepatitis B [1] Patent Details - The first Notice of Allowance relates to U.S. Patent Application No. 19/347,136, which includes claims for the ARCUS nuclease used in PBGENE-HBV [1] - The second Notice of Allowance pertains to U.S. Patent Application No. 19/273,982, covering any polypeptide that includes a novel, shortened polypeptide linker developed by Precision [1] - Both patents are expected to provide overlapping coverage across multiple patent families, strengthening the company's position in the market [1]

Core Insights - Precision BioSciences presented preclinical data for PBGENE-DMD, highlighting its potential for durable dystrophin expression and functional benefits in treating Duchenne muscular dystrophy (DMD) [1] - The data indicates that PBGENE-DMD could potentially treat up to 60% of DMD patients by restoring near full-length functional dystrophin protein through permanent gene correction [1] Group 1: Preclinical Data Findings - PBGENE-DMD treatment in a humanized DMD mouse model showed improvements in muscle pathology and biomarkers of muscle damage, with a 50-65% reduction in CK levels at 90 days post-treatment [1] - Treated mice maintained approximately 81% to 84% of maximal force output and 89% to 92% of tetanic force output compared to healthy mice over a nine-month period [1] - Evidence of therapeutic levels of functional dystrophin protein was observed in both skeletal and cardiac muscle, with increasing levels over time [1] Group 2: Treatment Mechanism and Design - PBGENE-DMD utilizes a gene excision approach, differentiating it from existing treatments like microdystrophin and exon skipping [1] - The therapy targets muscle satellite cells, which are essential for muscle regeneration, potentially providing long-term benefits [1] - The treatment is designed for DMD patients with mutations in exons 45-55, representing a significant portion of the patient population [1] Group 3: Clinical Trial and Regulatory Status - The Phase 1/2 FUNCTION-DMD clinical trial is set to enroll ambulatory DMD patients aged 2-7 with specific mutations, focusing on safety, tolerability, and efficacy [1] - PBGENE-DMD has received FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations, facilitating its development and potential market entry [1]

Core Insights - Precision BioSciences, Inc. will report its financial results for the fourth quarter and fiscal year 2025 on March 12, 2026, along with a business update [1] - The company specializes in gene editing therapies using its proprietary ARCUS® platform, aimed at addressing high unmet medical needs [1] Company Overview - Precision BioSciences is a clinical stage gene editing company based in Durham, North Carolina, focusing on in vivo gene editing therapies [1] - The ARCUS® platform is characterized by its unique cutting mechanism, smaller size, and simpler structure, which are designed to achieve more defined therapeutic outcomes [1] - The company's pipeline includes clinical stage candidates targeting genetic and infectious diseases where existing treatments are inadequate [1] Recent Developments - The FDA has granted Fast Track designation to PBGENE-DMD for the treatment of Duchenne muscular dystrophy (DMD) [1] - Precision BioSciences received $7.5 million from TG Therapeutics for achieving a clinical milestone related to the azercabtagene zapreleucel (azer-cel) in multiple sclerosis [1] - New preclinical study data supporting the safety and long-term efficacy of PBGENE-DMD will be presented at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference [1]

Core Viewpoint - Precision BioSciences, Inc. has achieved a clinical milestone related to its license agreement with TG Therapeutics, Inc. for the development of azercabtagene zapreleucel (azer-cel) in a Phase 1 clinical trial [1] Group 1: Company Achievements - The milestone payment was triggered by the progress of the Phase 1 clinical trial of azer-cel, indicating advancement in the clinical development of this gene editing therapy [1]