manufacturers; and other important factors discussed under the caption "Risk Factors†in our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025, and September 30, 2025 as any such factors may be updated from time to time in our other filings with the U.S. Securities and Exchange Commission (SEC), which are accessible on the SEC's website at [www.sec.gov] and the Investors page of our website unde ...

Core Viewpoint - Precision BioSciences, Inc. has received a Study May Proceed notification from the U.S. FDA, enabling the company to start clinical trial activities for its FUNCTION-DMD Phase 1/2 trial [1] Group 1 - The company specializes in gene editing using its proprietary ARCUS® platform to develop therapies for diseases with high unmet needs [1] - The FDA's notification allows Precision BioSciences to initiate Institutional Review Board (IRB) activities and activate clinical trial sites [1]

Financial Outlook - As of December 31, 2025, Precision BioSciences expects to report approximately $137 million in cash, cash equivalents, and restricted cash[8] - The company anticipates that its cash runway will extend through 2028, supported by existing cash, potential near-term licensee considerations, and fiscal discipline[9] Clinical Trials - Additional biopsy data from the ELIMINATE-B trial for PBGENE-HBV is expected in the first half of 2026[12] - The FUNCTION-DMD Phase 1/2 clinical trial in Duchenne muscular dystrophy patients is expected to dose the first patient in late Q1 or early Q2 2026, with initial data anticipated by year-end 2026[13] Strategic Priorities - The company has set strategic priorities for 2026, as announced in a press release on January 12, 2026[10]

Core Viewpoint - Precision BioSciences, Inc. is advancing its gene editing therapies through its proprietary ARCUS® platform, focusing on unmet medical needs and outlining strategic priorities for 2026, with significant progress in its lead programs and a strong financial position to support upcoming milestones [1][2]. Clinical Programs - The PBGENE-HBV program is in a Phase 1/2a ELIMINATE-B trial aimed at curing chronic Hepatitis B by eliminating cccDNA, with positive dose-dependent effects and antiviral activity reported [3][4]. - Safety data from the PBGENE-HBV trial indicated no dose-limiting toxicities at doses up to 0.8 mg/kg, with manageable adverse events observed [4][5]. - Additional dosing cohorts are being explored to optimize the therapeutic index, with 12 participants having completed at least one dose administration [5][6]. - The PBGENE-DMD program is set to begin its Phase 1/2 FUNCTION-DMD trial in late Q1 or early Q2 2026, targeting DMD patients with specific mutations, with initial data expected by the end of 2026 [8][10]. Partnered Programs - ECUR-506, developed by iECURE, is being evaluated for neonatal onset OTC deficiency and has received FDA RMAT designation, with data expected in the first half of 2026 [11]. - The azer-cel CAR T treatment is being developed by Imugene for diffuse large B-cell lymphoma, with Precision receiving an $8 million milestone payment due to progress [12]. - Additional milestone payments are anticipated from TG Therapeutics for azer-cel's ongoing Phase 1 trial in progressive multiple sclerosis [13]. Financial Position - Precision BioSciences expects to report approximately $137 million in cash and equivalents as of December 31, 2025, with a cash runway projected through 2028 to support ongoing clinical programs [14].

Core Viewpoint - The article discusses the investment strategy focused on clinical-stage biotech stocks, emphasizing the importance of scientific fundamentals in evaluating these investments [1]. Group 1: Investment Strategy - The investment style is long-only, targeting both long-term ideas and event-driven trading opportunities within the biotech sector [1]. - The author’s academic and medical background provides a unique perspective for assessing the scientific aspects of biotech stocks [1]. Group 2: Analyst's Position - The analyst holds a beneficial long position in the shares of DTIL, indicating confidence in the stock's potential [2]. - The article reflects the author's personal opinions and is not influenced by external compensation [2].

Core Viewpoint - The article discusses the investment strategy focused on clinical-stage biotech stocks, emphasizing the importance of scientific fundamentals in evaluating these investments [1]. Group 1: Investment Strategy - The investment style is long-only, targeting both long-term ideas and event-driven trading opportunities within the biotech sector [1]. - The author’s academic and medical background aids in assessing the scientific fundamentals of biotech stocks, which is crucial for making informed investment decisions [1]. Group 2: Analyst's Position - The analyst holds a beneficial long position in the shares of DTIL, indicating confidence in the stock's potential [2]. - The article reflects the author's personal opinions and is not influenced by compensation from any company mentioned [2].

Summary of Precision BioSciences Conference Call Company Overview - **Company**: Precision BioSciences (NasdaqCM:DTIL) - **Industry**: In-vivo gene editing - **Location**: Durham, North Carolina - **Focus**: Developing gene editing therapies for chronic hepatitis B and Duchenne muscular dystrophy (DMD) [2][3][4] Key Programs PBGene-HBV (Hepatitis B) - **Target Population**: 300 million people globally with chronic hepatitis B [2] - **Current Status**: Program initiated in the clinic late 2024, with ongoing data generation throughout 2025 and into 2026 [3][4] - **Mechanism**: Aims to eliminate cccDNA, the root cause of hepatitis B, rather than just reducing S antigen levels [9][10][12] - **Clinical Trial**: Phase 1 trial named "Eliminate B" with three cohorts, focusing on safety and efficacy [13][14] - **Safety Profile**: Well-tolerated across all doses, with manageable side effects [15][20] - **Data Trends**: Early cohorts show promising reductions in S antigen levels, with cohort three demonstrating sustained reductions [16][18] - **Future Plans**: Completion of cohort three dosing, potential to stop nucleoside analogs, and test for a cure [20][21] PBGene-DMD (Duchenne Muscular Dystrophy) - **Target Population**: Affects boys with a genetic disease leading to muscle loss and early mortality [21][22] - **Current Status**: IND filing expected by the end of 2025, with clinical trials anticipated to start in early 2026 [25][26] - **Mechanism**: Gene editing approach targeting mutations in exons 45 to 55, potentially benefiting up to 60% of DMD patients [22][24] - **Clinical Trial Design**: Phase 1, 2, 3 study design with a focus on safety and efficacy [25][26] Financials - **Recent Financing**: Raised $75 million from existing and new investors, providing a cash runway through 2028 [4] - **Investment Strategy**: Focused on two key programs to maximize capital efficiency and create value inflection points [35] Market Context - **Unmet Needs**: Both hepatitis B and DMD represent significant unmet medical needs, with current treatments lacking effectiveness [21][22][27] - **Competitive Landscape**: Current standard of care for hepatitis B involves nucleoside analogs, which do not address cccDNA, resulting in low functional cure rates (1%-3%) [29][30][31] Strategic Partnerships - **PBGene-HBV**: Potential for strategic partnerships for commercialization, especially for larger phase three trials [32] - **PBGene-DMD**: Opportunities for partnerships exist, but the company is capable of advancing this program independently [33] Future Outlook - **Data Readouts**: Anticipated data readouts for both programs in 2026, with potential for a Biologics License Application (BLA) for DMD by the end of 2028 [26][27] - **Investor Engagement**: Emphasis on demonstrating the effectiveness of gene editing to attract further investment and partnerships [35]

Core Insights - Precision BioSciences (DTIL) has been highlighted for its promising gene-editing programs, which the market has not fully recognized yet [2] Company Overview - The company is involved in developing innovative therapies and pharmaceuticals, with a focus on breakthrough treatments that have potential acquisition catalysts [2] Investment Group - The investment group "Compounding Healthcare" offers features such as model healthcare portfolios, a weekly newsletter, a daily watchlist, and a platform for dialogue and questions among investors [2]

Core Insights - The article discusses Precision BioSciences (DTIL) and its promising gene-editing programs, which have not yet gained significant market attention despite their potential [2]. Group 1: Company Overview - Precision BioSciences is involved in developing innovative gene-editing therapies that could be considered best-in-class within the biotech sector [2]. - The company has a pipeline of programs that are positioned to be breakthrough therapies, indicating strong future growth potential [2]. Group 2: Market Context - Despite positive updates from Precision BioSciences in 2023, the market has largely overlooked the company's advancements, suggesting a disconnect between the company's performance and market perception [2].

Core Points - Precision BioSciences held a business update call for AASLD 2025, featuring key executives including the CEO, CFO, and Chief Scientific Officer [1][2] - The call included a presentation format where speakers referenced specific slides for detailed information [2] Company Overview - The company is focused on advancements in the field of hepatic and infectious diseases, as indicated by the involvement of Dr. Mark Sulkowski, a renowned expert in these areas [1] - The leadership team consists of experienced professionals, highlighting the company's commitment to strong governance and expertise in its operations [1]