https://biotechpharmainvestor.substack.comBackground: Physician involved in clinical research. Investment style: Clinical-stage biotech stocks, long only, both long-term ideas and event-driven trading. My academic/medical background helps me evaluate the scientific fundamentals of biotech stocks.Due to seeking alpha rules I cannot cover here all stocks that I am following/trading. I write about such stock in substack.Analyst’s Disclosure:I/we have a beneficial long position in the shares of DTIL either thro ...

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 Insights - Several small-cap biotech and healthcare stocks experienced significant gains in after-hours trading on November 28, 2025, despite a lack of new news [1] Company Summaries - **BioAtla Inc. (BCAB)**: Shares surged 13.94% to $1.03 after closing at $0.9040, up 6.27%. The increase may be linked to financing agreements announced on November 21, including a $7.5 million advance and a Standby Equity Purchase Agreement allowing for the sale of up to $15 million in common stock at a 3% discount [2] - **Metagenomi Inc. (MGX)**: Stock rose 5.71% to $1.85 after a 3.55% gain to $1.75 during regular trading. The movement appears driven by investor sentiment or technical factors, with no new corporate updates [3] - **PAVmed Inc. (PAVM)**: Advanced 5.72% to $0.3900, recovering from a slight decline earlier in the day. The company reported a GAAP net loss of $6.3 million, or $(0.29) per share, with revenue dropping sharply to $5,000 from $996,000 year-over-year [4] - **Precision BioSciences, Inc. (DTIL)**: Gained 2.94% to $5.60, building on a 6.46% rise to $5.44. The company is set to present Phase 1 data from its ELIMINATE-B trial at the Hep-DART 2025 meeting, which may be boosting investor optimism [5] - **Reviva Pharmaceuticals Holdings, Inc. (RVPH)**: Edged up 2.04% to $0.57 after a 7.66% gain to $0.5625. The company narrowed its quarterly net loss to $4.0 million, or $0.06 per share, compared to $8.4 million, or $0.25 per share, in the prior year [6] - **Sonnet BioTherapeutics Holdings, Inc. (SONN)**: Rose 5.11% to $3.91, recovering from a 10.47% decline earlier in the day. The company adjourned a special meeting to allow more time for voting on a proposed combination with Hyperliquid Strategies Inc. and Rorschach I LLC, with over 95% of shares voting in favor [7] - **Entero Therapeutics, Inc. (ENTO)**: Gained 3.68% to $3.10 after a 5.28% rise to $2.99. The company announced a rebranding to GridAI Technologies Corp., effective December 1, 2025, following its acquisition of GRID AI Corp. The new ticker symbol "GRDX" will debut on the Nasdaq Capital Market [8]

Core Insights - Precision BioSciences, Inc. is a clinical stage gene editing company focused on developing in vivo gene editing therapies for diseases with high unmet needs [1] Company Announcement - The company announced it will deliver an oral presentation at the Hep-DART 2025 meeting scheduled for December 7–11, 2025, in Honolulu, Hawaii [1] - The presentation will showcase data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV [1]

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]

Financial Performance - Consolidated net profit for the first half of FY 2025 reached JPY 500.3 billion, an increase of JPY 61.8 billion year-on-year, marking a record high level [2] - The strong performance was primarily driven by robust results in the non-resource sector, despite extraordinary gains from asset replacements [2] - Progress toward the full year profit forecast of JPY 900 billion has reached 56%, exceeding initial expectations [2] Profit Forecast - The full year consolidated net profit forecast remains unchanged at JPY 900 billion, while the core profit forecast has been revised to a range from JPY 800 billion to JPY 820 billion [3] - The initial core profit plan was set between JPY 770 billion and JPY 850 billion, but the lower limit has been raised due to steady progress in the first half [3] Segment Forecast - The forecast for Metals & Minerals has been revised downward due to challenging circumstances in the first half [4] - Conversely, forecasts for Textile, Food, ICT & Financial Business, The 8th, and Others have been revised upward [4]

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]