Precision BioSciences(US:DTIL)2025-05-15 11:34PART I. FINANCIAL INFORMATION Item 1. Financial Statements (unaudited) Precision BioSciences reported a significant Q1 2025 revenue decrease to $29 thousand, a net loss of $20.6 million, and reduced total assets Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $77,223 | $85,899 | | Restricted cash | $22,566 | $22,569 | | Total Assets | $124,411 | $136,388 | | Total Liabilities | $75,074 | $79,995 | | Total Stockholders' Equity | $49,337 | $56,393 | Condensed Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Revenue | $29 | $17,584 | | Total operating expenses | $22,141 | $21,771 | | Operating loss | $(22,112) | $(4,187) | | Net (loss) income | $(20,565) | $8,588 | | Net (loss) income per share (Basic & Diluted) | $(2.21) | $1.70 | Condensed Statement of Cash Flows (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,052) | $(18,981) | | Net cash used in investing activities | $(314) | $(26) | | Net cash provided by financing activities | $10,687 | $40,095 | | Net (decrease) increase in cash | $(8,679) | $(21,088) | Notes to Condensed Financial Statements Notes detail the company's strategic shift to in vivo gene editing, key collaborations, and financial specifics like loan and warrant liabilities - The company has strategically shifted to focus exclusively on developing in vivo gene editing therapies, with its former CAR T programs now accounted for as discontinued operations3031 - Revenue from the Novartis collaboration was less than $0.1 million in Q1 2025, down from $4.5 million in Q1 2024. Deferred revenue related to this agreement was $26.2 million as of March 31, 202554 - The company has a $22.5 million term loan with Banc of California, with a stated interest rate of 6.00% as of March 31, 20253839 - R&D expenses are broken down by program, with PBGENE-DMD and PBGENE-3243 seeing increased spending, while PBGENE-HBV spending decreased as it moved into the clinic81 - Warrants from the March 2024 public offering are classified as a liability, valued at $3.6 million as of March 31, 2025, with changes in fair value recorded in the statement of operations8284 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the strategic focus on ARCUS gene editing, program updates for PBGENE-HBV and PBGENE-DMD, and financial outlook - The company is a clinical-stage gene editing company focused on developing in vivo therapies for genetic and infectious diseases using its proprietary ARCUS platform88 - PBGENE-HBV for chronic Hepatitis B is in a global first-in-human clinical trial. Initial data from the first cohort was safe and well-tolerated, with substantial HBsAg reduction. The FDA has granted Fast Track designation909192 - The company is prioritizing and accelerating the PBGENE-DMD program for Duchenne muscular dystrophy, targeting an IND and/or CTA filing in 2025 with clinical data expected in 202697 - Development of PBGENE-3243 for mitochondrial disease is being paused to accelerate PBGENE-DMD and conserve resources100 Results of Operations Comparison (in thousands) | Line Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $29 | $17,584 | $(17,555) | | Research and development | $13,588 | $13,343 | $245 | | General and administrative | $8,553 | $8,428 | $125 | | Net (loss) income | $(20,565) | $8,588 | $(29,153) | - The company believes its existing cash and cash equivalents of $99.8 million will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2026155 Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk is interest rate sensitivity on its $99.8 million cash, with no material impact expected from fluctuations - The company's main market risk is interest rate sensitivity on its cash, cash equivalents, and restricted cash, which totaled $99.8 million at March 31, 2025165 - A hypothetical 10% change in interest rates is not expected to have a material impact on the company's financial condition165 Controls and Procedures Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025167 - No material changes were made to the internal control over financial reporting during the three months ended March 31, 2025168 PART II. OTHER INFORMATION Legal Proceedings The company is not currently involved in any material legal proceedings - As of the report date, the company is not involved in any material legal proceedings170 Risk Factors The company faces significant risks including historical losses, funding needs, unproven technology, regulatory complexities, and capital raising limitations - The company has a history of significant operating losses ($503.0 million accumulated deficit as of March 31, 2025) and expects to incur losses for the foreseeable future, requiring substantial additional funding172176 - The ARCUS gene editing platform is a novel technology, making it difficult to predict the time, cost, and success of product development. The company has not yet been able to assess the safety and efficacy of most of its product candidates in humans193 - The regulatory landscape for gene editing therapies is rigorous, complex, and subject to change, which could result in delays, termination of development, or unexpected costs215 - The company relies on third parties for collaborations (e.g., Novartis), conducting clinical trials (CROs), and manufacturing (CMOs), and the failure of these parties to perform could substantially harm the business355362368 - As of the filing date, the company is subject to the "Baby Shelf Rule," which limits the amount of funds it can raise through its Form S-3 registration statement to one-third of its public float in any 12-month period179 Unregistered Sales of Equity Securities and Use of Proceeds On January 6, 2025, the company issued 220,712 unregistered common shares to TG Subsidiary for a $2.5 million deferred cash payment - On January 6, 2025, the company issued 220,712 shares of common stock to TG Subsidiary in exchange for a $2.5 million deferred cash payment related to their license agreement439 - The issuance was an unregistered sale, relying on the Section 4(a)(2) exemption under the Securities Act439 Other Information Two executive officers, Jeff Smith and Alex Kelly, established Rule 10b5-1 trading plans for stock sales and RSU tax obligations - Chief Research Officer Jeff Smith entered into a Rule 10b5-1 trading plan to sell up to 7,931 shares of common stock between May 2025 and January 2026442 - Chief Financial Officer Alex Kelly entered into a Rule 10b5-1 sell-to-cover instruction to sell shares to cover tax obligations from vesting RSUs443 Exhibits This section lists exhibits filed with the Form 10-Q, including corporate documents and Sarbanes-Oxley certifications