Every 8-K that Precision BioSciences, Inc. (DTIL) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow DTIL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DTIL filings page.
Precision BioSciences, Inc. (DTIL) reported that the first patient has been dosed in its Phase 1/2 FUNCTION-DMD clinical trial of PBGENE-DMD, an in vivo gene-editing therapy for Duchenne muscular dystrophy (DMD). The first dosing occurred at Arkansas Children’s Hospital, a specialized Duchenne care center.
PBGENE-DMD uses the company’s ARCUS® platform to excise exons 45-55 of the dystrophin gene via two ARCUS nucleases delivered in a single AAV, aiming to restore a near full-length functional dystrophin protein. The trial is enrolling ambulatory boys aged 2–7 with mutations between exons 45 and 55, a group representing up to 60% of boys with DMD, with initial safety data expected by year-end 2026.
Precision BioSciences, Inc. reported second quarter 2026 results and highlighted clinical progress in its gene editing pipeline. For the quarter ended June 30, 2026, revenue was $0 and net loss was $32.7 million, or $(1.26) per share, driven largely by a non-cash loss from the change in fair value of warrant liabilities. Research and development expenses were $12.4 million and general and administrative expenses were $6.8 million.
Cash, cash equivalents and restricted cash totaled $112.4 million as of June 30, 2026, which the company expects will fund operations and data milestones for PBGENE-HBV and PBGENE-DMD through 2028. In its ELIMINATE-B trial for chronic hepatitis B, PBGENE-HBV showed biopsy evidence of a 1-log reduction in cccDNA-derived transcripts with less than 1% remaining in one patient and sustained pgRNA loss in 100% of evaluable patients. PBGENE-DMD for Duchenne muscular dystrophy is in a Phase 1/2 trial now recruiting boys ages 2 to 7, with initial safety data targeted by year-end 2026. Partnered programs in OTC deficiency and oncology/multiple sclerosis advanced, and leadership changes were made including appointing Naresh Tanna as Chief Financial Officer. The company also joined the Russell 2000 Index in June 2026.
Precision BioSciences, Inc. restructured its senior leadership team, effective August 1, 2026. Alex Kelly, age 60, was promoted from Chief Financial Officer to Chief Operating Officer with an annual base salary of $510,000 and a target annual bonus equal to 45% of base salary.
The Board appointed Naresh Tanna, age 45, as Chief Financial Officer and principal financial officer with a base salary of $400,000 and a 40% target bonus, pro-rated for 2026. Vice President of Finance Mei Burris, age 40, will assume responsibilities as principal accounting officer and Chief Accounting Officer. A related press release states these leadership updates support advancement of the PBGENE-HBV and PBGENE-DMD in vivo gene editing programs toward upcoming clinical milestones.
Precision BioSciences, Inc. furnished an updated corporate deck highlighting clinical progress in its gene-editing programs. In chronic hepatitis B, PBGENE-HBV from the ELIMINATE-B study showed liver biopsy data where it directly eliminated cccDNA, leading to a 1-log (10-fold) reduction in cccDNA-derived transcripts. The company is targeting year-end 2026 for the next update on this program.
The deck also notes activation of a second clinical site at Washington University School of Medicine in St. Louis for the FUNCTION-DMD trial evaluating PBGENE-DMD for Duchenne muscular dystrophy, with initial safety data also targeted for year-end 2026. The information is furnished under Regulation FD and not deemed filed for liability purposes.
Precision BioSciences, Inc. entered into a First Amendment to its Amended and Restated Loan and Security Agreement with Banc of California on June 10, 2026. This amendment extends the maturity date of the company’s Term Loan from June 30, 2027 to December 31, 2029, giving the company a longer period before the loan must be repaid under the existing facility.
Precision BioSciences reported new Phase 1 ELIMINATE-B data for its gene-editing therapy PBGENE-HBV in chronic hepatitis B. Liver biopsies showed direct elimination of cccDNA with a 1-log (10-fold) reduction in cccDNA-derived transcripts after dosing, and further edits in the small fraction remaining inactivated viral polymerase to stop replication.
Blood pgRNA, a marker that comes from cccDNA, was completely lost in 100% of treated patients with detectable pgRNA at baseline, and all evaluated patients showed substantial HBsAg declines, suggesting broad antiviral activity. Across 38 doses in 16 patients, no dose-limiting toxicities occurred; common effects were short-lived infusion reactions and reversible liver enzyme elevations. A mitigation protocol for hypotension and liver labs has been implemented, with no new Grade 3 events reported since.
Precision BioSciences, Inc. reported the results of its annual stockholder meeting and related corporate changes. Stockholders approved an amendment and restatement of the 2019 Incentive Award Plan, increasing the shares of common stock available for issuance by 3,800,000 shares.
They also approved an amendment to the Amended and Restated Certificate of Incorporation to provide for the exculpation of certain officers as permitted by Delaware law, which became effective upon filing on May 22, 2026. All six proposals on the ballot, including director elections, auditor ratification, say-on-pay, the incentive plan amendment, the charter amendment, and a potential adjournment, received sufficient votes for approval.
Precision BioSciences reported first quarter 2026 results and highlighted progress across its in vivo gene editing programs. Revenue was $10.8 million, up from less than $0.1 million a year earlier, mainly from milestone revenue under a TG Therapeutics license and a legacy collaboration.
Research and development expenses were $13.1 million and general and administrative expenses were $6.8 million, leading to a net loss of $18.4 million, or $(0.75) per share, compared with a $20.6 million loss in 2025. Cash, cash equivalents and restricted cash totaled $125.8 million as of March 31, 2026, which the company believes can fund operations and data milestones for PBGENE-HBV and PBGENE-DMD through 2028.
Operationally, the company advanced its PBGENE-HBV hepatitis B program through multiple cohorts in the ELIMINATE-B trial and secured a late-breaking poster at the 2026 EASL Congress. It also moved PBGENE-DMD for Duchenne muscular dystrophy into the Phase 1/2 FUNCTION-DMD trial after FDA IND clearance and Fast Track designation, activating the first clinical site and enrolling patients.
Precision BioSciences is updating investors on PBGENE-DMD, its in vivo gene-editing program for Duchenne muscular dystrophy. The therapy uses a single AAV vector encoding two ARCUS nucleases to excise exons 45–55 of the dystrophin gene, aiming to restore near full-length, functional dystrophin for up to 60% of patients.
Preclinical DMD mouse data show increased dystrophin protein, up to about 85% dystrophin-positive myofibers, improved creatine kinase levels, and durable muscle force gains out to nine months, with supportive safety data in mice and non-human primates. The FDA granted US IND clearance for PBGENE-DMD in early Q1 2026, and the Phase 1/2 FUNCTION-DMD trial plans to test a 1 × 10¹⁴ vg/kg dose, targeting enrollment of 3–5 children in 2026 with initial multi-patient data expected by year end.
The company also highlights its HBV gene-editing program, additional 2026 data milestones across its pipeline, and reports approximately $137 million in cash, cash equivalents, and restricted cash as of year-end 2025, which it believes can support operations through multiple catalysts into 2028.
Precision BioSciences reported a sharp swing to profitability in the fourth quarter of 2025 while advancing its in vivo gene editing pipeline. Q4 revenue rose to $34.2 million from $0.6 million a year earlier, driving net income of $20.1 million versus a prior net loss of $17.8 million.
For 2025, revenue was $34.3 million compared with $68.7 million in 2024, and the company posted a net loss of $45.7 million versus net income of $7.2 million, reflecting lower collaboration revenue. Cash, cash equivalents, and restricted cash were $137.2 million as of December 31, 2025, supported by a $75 million equity offering and milestone payments, and management expects this to fund operations through 2028. Clinically, PBGENE-HBV showed dose-dependent antiviral activity with repeat LNP dosing, PBGENE-DMD received FDA Fast Track and IND clearance for the Phase 1/2 FUNCTION-DMD trial, and partnered programs delivered regulatory milestones and additional data catalysts for 2026.
Precision BioSciences received U.S. FDA clearance of an investigational new drug application for PBGENE-DMD, its first-in-class in vivo gene editing therapy for Duchenne muscular dystrophy. This “Study May Proceed” notification allows initiation of site activation for the Phase 1/2 FUNCTION-DMD clinical trial in ambulatory patients.
PBGENE-DMD uses a gene excision approach to permanently correct dystrophin gene mutations between exons 45 and 55, a region affecting about 60% of boys with Duchenne muscular dystrophy. The therapy is designed to restore near full-length dystrophin protein at about 80% of normal size, substantially larger than micro-dystrophin constructs approved or in development.
The company plans to activate the first U.S. clinical site in the first half of 2026 and expects initial data from multiple patients by year end 2026. PBGENE-DMD has Rare Pediatric Disease and Orphan Drug designations, and a virtual investor event is planned in March to discuss the program and trial.
Precision BioSciences reports preliminary year-end liquidity and key clinical timelines. The company expects to report approximately $137 million in cash, cash equivalents and restricted cash as of December 31, 2025, based on unaudited, still-subject-to-change figures. It believes that existing cash, potential near-term consideration from license partners, continued fiscal discipline and access to its at-the-market facility together should extend its cash runway through 2028.
The company also outlines upcoming milestones for its gene-editing programs. For the ELIMINATE-B trial of PBGENE-HBV, additional biopsy data are expected in the first half of 2026, with completion of dosing in Cohorts 3, 4 and 5, selection of an optimal dose regimen to stop nucleos(t)ide analog therapy, and initiation of Part 2 expansion. Pending investigational new drug clearance, the FUNCTION-DMD Phase 1/2 trial in Duchenne muscular dystrophy is expected to dose its first patient in late-Q1 or early-Q2 2026, with initial data from multiple patients anticipated by year end 2026.
Precision BioSciences announced an underwritten offering of 10,815,000 shares of common stock with accompanying one-half warrants to purchase up to 5,407,500 shares at a combined price of $6.14. In lieu of common stock for certain investors, the company is also selling pre-funded warrants to purchase up to 1,400,000 shares with accompanying one-half warrants to purchase up to 700,000 shares at a combined price of $6.139995. Each whole warrant is immediately exercisable at $7.25 per share and expires five years from issuance.
The company estimates net proceeds of approximately $70.0 million, excluding any proceeds from warrant exercises. Funds are intended for ongoing and planned research and development, working capital, and general corporate purposes. The securities are offered off an effective Form S-3 shelf, with closing expected on November 12, 2025, subject to customary conditions. Beneficial ownership limits include 4.99% (or 9.99% at holder election) and 19.99% thresholds as outlined.
Precision BioSciences furnished an update on its ELIMINATE-B Phase 1 study of PBGENE-HBV and announced related webcast details. As of October 31, 2025, nine evaluable patients were dosed across three ascending cohorts (0.2, 0.4, 0.8 mg/kg), with 22 total administrations. All treated patients showed measurable HBsAg declines across dose levels, with durability improving at higher doses.
Cohort 1 included a patient with a durable ~50% HBsAg reduction at 9 months. In Cohort 2, durable declines were maintained after the first administration and deepened after subsequent doses, reaching up to 66%. In Cohort 3, all patients showed early HBsAg reductions; one had a deepening response to two doses with a 64% decline, and levels fell as low as 188 IU/mL. A paired liver biopsy confirmed ARCUS-mediated editing of HBV DNA, supporting the therapy’s mechanism. PBGENE-HBV was well tolerated with no dose-limiting toxicities; transient infusion reactions and liver enzyme elevations resolved, including one reversible Grade 3 AST. The company plans to complete Cohort 3 and finalize in Q1 2026, then move to Part 2 to evaluate an optimized regimen.
Precision BioSciences, Inc. furnished an update on its financials, announcing results for the quarter ended September 30, 2025. The company disclosed the information under Item 2.02 and provided the full details via a press release.
The press release is included as Exhibit 99.1, which is incorporated by reference. The company’s common stock trades on the Nasdaq Capital Market under the symbol DTIL.
Precision BioSciences, Inc. updated employment agreements for its key Section 16 officers, including the CEO, CFO, General Counsel, and Chief Research Officer, to support executive retention.
The amended agreements align terms with each executive’s current base salary and target bonus, change cash severance to lump-sum payments, and add protections for terminations without cause in connection with a defined change in control or restructuring event. They also provide for additional expense coverage.
To secure these obligations, the company established escrow arrangements with JPMorgan Chase Bank, N.A., funding severance and expense amounts in dedicated accounts. Interest on the escrowed funds and any unused balances revert to Precision BioSciences.