Financial Performance - Total revenues for Q4 2024 were $0.6 million, a decrease of $6.4 million from $7.0 million in Q4 2023, primarily due to the conclusion of the Prevail agreement[25]. - Total revenues for the fiscal year 2024 were $68.7 million, an increase of $20.0 million from $48.7 million in fiscal year 2023, driven by revenue from the Prevail agreement and new license agreements[29]. - Net loss for Q4 2024 was $17.8 million, or $(2.22) per share, compared to a net loss of $16.3 million, or $(4.06) per share, in Q4 2023[28]. - Net income from continuing operations was $7.2 million for the year ended December 31, 2024, a significant improvement from a net loss of $42.5 million in 2023[32]. - The company reported a net income of $7.2 million, or $1.05 per share basic and $1.04 per share diluted for the year ended December 31, 2024, compared to a net loss of $61.3 million, or $(15.96) per share in 2023[33]. - Total revenue for the year ended December 31, 2024, was $68.7 million, compared to $48.7 million in 2023, representing a growth of approximately 41.2%[45]. - Total operating expenses for the year ended December 31, 2024, were $94.9 million, slightly higher than $92.5 million in 2023[45]. Expenses - Research and development expenses increased to $15.9 million in Q4 2024 from $13.4 million in Q4 2023, mainly due to rising costs associated with the PBGENE-HBV program entering clinical trials[26]. - General and administrative expenses rose to $9.6 million in Q4 2024, up from $8.5 million in Q4 2023, attributed to higher employee-related expenses and share-based compensation[27]. - Research and development expenses increased to $59.6 million for the year ended December 31, 2024, up from $53.4 million in 2023, reflecting a $6.2 million rise primarily due to PBGENE-HBV program costs[30]. - General and administrative expenses decreased to $35.3 million for the year ended December 31, 2024, down from $39.1 million in 2023, a reduction of $3.8 million attributed to operational discipline and lower headcount[31]. Cash Position - The company has approximately $108.5 million in cash, cash equivalents, and restricted cash as of December 31, 2024, expected to extend its cash runway into the second half of 2026[24]. - The company had cash, cash equivalents, and restricted cash of $108.5 million as of December 31, 2024, down from $116.7 million in 2023[47]. Clinical Development - PBGENE-HBV demonstrated substantial antiviral activity with a reduction in Hepatitis B surface antigen after the first administration at the lowest dose level[4]. - The first patient cohort for PBGENE-HBV has been dosed, establishing safety and early efficacy, with no Grade ≥2 treatment-related adverse events reported[8]. - The ELIMINATE-B trial for PBGENE-HBV is designed to investigate multiple ascending dose levels in patients with chronic Hepatitis B, targeting a large patient population of approximately 300 million worldwide[5]. - The company plans to provide ongoing updates on clinical data for PBGENE-HBV throughout 2025, with significant milestones expected[11]. - The company plans to provide ongoing updates on the PBGENE-HBV study throughout 2025, including data at higher dose levels[37]. Shareholder Equity - Total stockholders' equity increased to $56.4 million as of December 31, 2024, compared to $18.9 million in 2023[47]. - The weighted average shares outstanding increased to 6,832,982 basic and 6,883,911 diluted for the year ended December 31, 2024, compared to 3,841,405 for both basic and diluted in 2023[34].

Core Insights - The article discusses the author's extensive background in biomedicine and bioengineering, emphasizing over 20 years of experience in the research and development of novel Cell & Gene Therapies (CGT) aimed at addressing various clinical needs [1] Group 1: Company Analysis - The author intends to focus on analyzing biotechnology, pharmaceutical, Medtech, and healthcare stocks, leveraging their expertise in life sciences to evaluate the potential of novel treatments and their ability to generate shareholder returns [1] Group 2: Industry Perspective - The article highlights the growing importance of CGT in the healthcare sector, indicating a significant opportunity for investment in companies that are innovating in this space [1]

Core Insights - Precision BioSciences, Inc. has revealed initial results from the first administration of PBGENE-HBV in cohort 1 of the ELIMINATE-B trial, which targets chronic Hepatitis B patients who are HBeAg-negative [1][4] - The trial is designed to assess PBGENE-HBV at multiple ascending dose levels, with the first dose being 0.2 mg/kg, and aims to establish the optimal dose and administration schedule [2][4] Group 1 - PBGENE-HBV was found to be safe and well tolerated in all three participants of cohort 1 after the initial administration [2][3] - No participants experienced Grade ≥2 treatment-related adverse events or serious adverse events [3] - A significant reduction in Hepatitis B surface antigen (HBsAg) was observed in two of the three participants following the first administration [3] Group 2 - The ELIMINATE-B study is currently enrolling patients in Moldova, Hong Kong, and New Zealand [4] - The company plans to complete subsequent administrations in cohort 1 patients and will escalate to higher dose levels to effectively eliminate covalently closed circular DNA (cccDNA) and inactivate integrated HBV DNA [4] - Precision BioSciences intends to share detailed clinical data throughout 2025 [5] Group 3 - HC Wainwright analyst Patrick Trucchio maintains a Buy rating on Precision BioSciences with a price target of $60 [5] - Following the news, DTIL stock increased by 9.22% to $5.63 [5]

Core Insights - Precision BioSciences' partner iECURE reported promising clinical efficacy and safety data for ECUR-506 in the Phase 1/2 OTC-HOPE study, aimed at treating neonatal-onset Ornithine Transcarbamylase deficiency [1][2] - The treatment was well tolerated in the first patient, with no significant safety concerns apart from mild asymptomatic transaminitis observed at four weeks [2] - BMO Capital Markets upgraded Precision BioSciences, citing early clinical validation for the ARCUS gene editing platform based on the initial data from ECUR-506 [3][5] Company Developments - Precision BioSciences is advancing its PBGENE-HBV program, which aims to deliver a functional cure for chronic hepatitis B, with a Phase 1 trial named ELIMINATE-B currently underway [4] - The company expects to report data from the ELIMINATE-B trial as it progresses through 2025 [4] - BMO Capital analysts predict that the HBV readout in 2025 could lead to a stock price increase of 100-200% or more [5] Market Reaction - Following the positive news regarding ECUR-506, DTIL stock rose by 25.8%, reaching $5.66 [5]

Company Performance - Precision BioSciences reported a quarterly loss of $2.83 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.79, representing an earnings surprise of -258.23% [1] - The company posted revenues of $0.58 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 93.22%, compared to revenues of $13.12 million a year ago [2] - Over the last four quarters, Precision BioSciences has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - Precision BioSciences shares have declined approximately 17.7% since the beginning of the year, while the S&P 500 has gained 20.1% [3] - The current status of estimate revisions for the company is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.43 on revenues of $9.5 million, and for the current fiscal year, it is $4.08 on revenues of $85.4 million [7] - The outlook for the Medical - Biomedical and Genetics industry, where Precision BioSciences operates, is currently in the top 36% of Zacks industries, suggesting a favorable environment for stock performance [8]

Financial Performance - The company reported a net loss per share of $2.25 for the current quarter, compared to a net loss of $2.10 in the previous quarter[14]. - The net loss for the three months ended September 30, 2024, was $16,425 million, compared to a net loss of $8,079 million in the same period of 2023, indicating a worsening of 103.1%[16]. - For the nine months ended September 30, 2024, the net income was $24,912,000 compared to a net loss of $45,030,000 in the same period of 2023, indicating a significant improvement[20]. - The basic net loss per share for the three months ended September 30, 2024, was $(2.25), compared to $(2.10) for the same period in 2023[130]. Revenue and Growth - Revenue for the three months ended September 30, 2024, was $13,120 million, an increase from $8,079 million in the same period of 2023, representing a year-over-year growth of 62.5%[16]. - The Company recognized revenue of $52.7 million under the Prevail Agreement during the nine months ended September 30, 2024, compared to $23.4 million for the same period in 2023[99]. - Revenue recognized under the TG License Agreement for the nine months ended September 30, 2024, was $8.0 million, with no revenue recognized in the third quarter of 2024[87]. - Revenue recognized under the Novartis Agreement for the three months ended September 30, 2024, was $0.6 million, a decrease from $7.6 million for the same period in 2023[95]. Assets and Liabilities - As of September 30, 2024, total assets decreased to $153.258 million from $159.781 million as of December 31, 2023[12]. - Current liabilities significantly reduced to $11.982 million from $49.987 million as of December 31, 2023[12]. - Total stockholders' equity increased to $64.866 million from $18.861 million as of December 31, 2023[13]. - Cash and cash equivalents at the end of the period were $98,752,000, down from $122,231,000 at the end of the previous year[20]. Operating Expenses - Research and development expenses decreased to $13,084 million for the three months ended September 30, 2024, down from $15,850 million in the same period of 2023, a reduction of 17.5%[16]. - Total operating expenses for the three months ended September 30, 2024, were $21,851 million, compared to $25,483 million in the same period of 2023, reflecting a decrease of 14.4%[16]. - The total lease cost for the year 2024 was $2.022 million, a decrease from $2.530 million in 2023[72]. Funding and Capital - The company will need substantial additional funding to continue its research programs and product development activities[11]. - The Company raised approximately $37.0 million in net proceeds from the March 2024 Public Offering of 2,500,000 shares at $16.00 per share[79]. - The company is focused on raising additional capital to fund ongoing research and development and achieve profitable operations[22]. Competition and Market Conditions - The company faces significant competition in rapidly changing industries, which may impact its financial condition[11]. - The regulatory landscape for therapeutic product candidates is complex and subject to change, which could result in unexpected costs[11]. Stock and Equity - The balance of common shares as of September 30, 2023, was 3,882,739, reflecting an increase from 3,725,689 shares as of December 31, 2022[18]. - The Company has undergone a 1-for-30 reverse stock split effective February 13, 2024, adjusting all historical share amounts accordingly[27]. - As of September 30, 2024, there were 29,935 stock options outstanding under the 2015 Stock Incentive Plan, with no remaining stock options available to be granted[104]. Cash Flow and Financing Activities - Net cash used in operating activities for the nine months ended September 30, 2024, was $39,762,000, a decrease from $75,691,000 in the same period of 2023[20]. - The company reported a net cash provided by financing activities of $44,530,000 for the nine months ended September 30, 2024, compared to $2,559,000 in the same period of 2023[20]. - The Company’s 2024 Term Loan has a principal amount of $22.5 million, used to repay the outstanding balance under the Revolving Line[60]. Future Outlook - The company plans to continue its market expansion and product development strategies to enhance future revenue growth[16]. - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[11]. - The company has a limited operating history, making it difficult to evaluate current business and future prospects[11].

Financial Position - As of September 30, 2024, Precision BioSciences, Inc. expects to report approximately $121 million in cash, cash equivalents, and restricted cash[2]. - The financial results for the quarter ended September 30, 2024, are still under review by the independent registered public accounting firm, which may lead to changes in the reported figures[2]. - Forward-looking statements indicate expectations regarding cash balances, clinical development, and regulatory processes, but actual results may differ due to various risks and uncertainties[5]. Clinical Development - The company received clinical trial application (CTA) clearance in Moldova for its lead candidate, PBGENE-HBV, aimed at treating chronic hepatitis B[3]. - The acceptance of the CTA for the in vivo gene editing program PBGENE-HBV was announced on October 24, 2024[4].

Company Overview - Precision BioSciences (DTIL) shares increased by 6.1% to $8.56, following a significant trading volume, contrasting with an 11.8% decline over the past four weeks [1][2] Clinical Developments - The rise in stock price is linked to positive investor sentiment regarding the company's clinical-stage pipeline, particularly the lead gene therapy program PBGENE-HBV aimed at curing chronic hepatitis B [2] - In late September, Precision BioSciences submitted clinical trial applications in multiple regions to initiate an early-stage study for PBGENE-HBV and is preparing additional regulatory submissions as part of its global phase I strategy [2] Financial Expectations - The company is projected to report a quarterly loss of $0.79 per share, reflecting a year-over-year increase of 73.7%, while revenues are expected to be $8.5 million, down 35.2% from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Precision BioSciences is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Alector (ALEC), experienced a 3.5% decline to $4.92, despite a 13.3% return over the past month [4] - Alector's consensus EPS estimate has also remained unchanged at -$0.53, showing no year-over-year change, and holds a Zacks Rank of 3 (Hold) [5]

Core Viewpoint - Momentum investing focuses on "buying high and selling higher," contrasting with traditional strategies of "buying low and selling high" [1] Group 1: Momentum Investing Strategy - Momentum investing can be risky as stocks may lose momentum if their valuations exceed future growth potential [1] - Identifying the right entry point for momentum stocks is challenging, leading to potential losses if the stock price does not continue to rise [1] Group 2: Investment Opportunities - Investing in bargain stocks that have recently shown price momentum can be a safer strategy [2] - The Zacks Momentum Style Score is useful for identifying strong momentum stocks, while the 'Fast-Paced Momentum at a Bargain' screen helps find attractively priced fast-moving stocks [2] Group 3: Precision BioSciences (DTIL) Analysis - Precision BioSciences (DTIL) has seen a price increase of 14.5% over the past four weeks, indicating growing investor interest [3] - DTIL has gained 1.5% over the past 12 weeks, demonstrating its ability to deliver positive returns over a longer timeframe [4] - The stock has a beta of 1.7, suggesting it moves 70% more than the market in either direction, indicating fast-paced momentum [4] Group 4: Valuation and Earnings Estimates - DTIL has a Momentum Score of A, suggesting it is an opportune time to invest in the stock [5] - The stock has a Zacks Rank 1 (Strong Buy) due to upward revisions in earnings estimates, which typically attract more investors [6] - DTIL is trading at a Price-to-Sales ratio of 0.85, indicating it is relatively cheap at 85 cents for each dollar of sales [6] Group 5: Additional Investment Options - Besides DTIL, there are other stocks that meet the criteria of the 'Fast-Paced Momentum at a Bargain' screen, presenting further investment opportunities [7] - Zacks offers over 45 Premium Screens tailored to different investing styles, which can help identify winning stock picks [8]

Core Viewpoint - Precision BioSciences (DTIL) shows significant upside potential with a mean price target of $39.61, indicating a 307.9% increase from its current price of $9.71 [1] Price Targets and Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $19.39, suggesting variability in analyst predictions. The lowest estimate of $19 indicates a 95.7% increase, while the highest target of $60.06 suggests a potential surge of 518.5% [2] - A low standard deviation among price targets indicates a high degree of agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [7] Earnings Estimates - Analysts are optimistic about DTIL's earnings prospects, as indicated by a strong consensus in revising EPS estimates higher, which correlates with near-term stock price movements [9] - Over the past 30 days, one estimate has increased, leading to a Zacks Consensus Estimate rise of 127.4% [10] - DTIL holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential upside [11]