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]

Group 1: Earnings Performance - Precision BioSciences reported quarterly earnings of $3.46 per share, significantly beating the Zacks Consensus Estimate of a loss of $0.77 per share, and improving from a loss of $3 per share a year ago, representing an earnings surprise of 549.35% [1] - The company posted revenues of $49.9 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 487.04%, compared to year-ago revenues of $19.79 million [2] - Over the last four quarters, Precision BioSciences has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Group 2: Stock Performance and Outlook - Precision BioSciences shares have declined approximately 13.1% since the beginning of the year, while the S&P 500 has gained 15.8% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.79 on $8.5 million in revenues, and -$0.94 on $44 million in revenues for the current fiscal year [7] - The Zacks Rank for Precision BioSciences is currently 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Precision BioSciences belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact investor decisions [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | | | | ...

Exhibit 99.1 Precision BioSciences Reports Second Quarter 2024 Financial Results and Provides Business Update - Wholly owned programs PBGENE-HBV for Chronic Hepatitis B virus and PBGENE-PMM for m.3243 mitochondrial disease on track for IND and/or CTA submissions in 2024 and 2025, respectively - Expanded Hepatitis Scientific Advisory Board with addition of world-class clinical investigators Mark Sulkowski, M.D. and Jordan Feld, M.D., M.P.H. - Sufficient capital to realize Phase 1 clinical data for multiple i ...