Earnings summaries and quarterly performance for PRECISION BIOSCIENCES.
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Recent press releases and 8-K filings for DTIL.
Precision BioSciences Outlines 2026 Strategic Priorities and Financial Position
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences announced its 2026 strategic priorities will focus on the continued advancement of its clinical-stage programs, PBGENE-HBV for Chronic Hepatitis B and PBGENE-DMD for Duchenne Muscular Dystrophy.
- The company reported unaudited cash, cash equivalents, and restricted cash of approximately $137 million as of December 31, 2025, which is anticipated to provide a cash runway through 2028.
- For PBGENE-HBV, data updates from the Phase 1/2a ELIMINATE-B trial are expected at medical conferences in 2026, with additional biopsy data anticipated in the first half of 2026.
- For PBGENE-DMD, IND clearance is expected in Q1 2026 for its Phase 1/2 FUNCTION-DMD study, with initial data from multiple patients expected in 2026.
- Precision received an $8 million milestone payment in Q4 2025 from Imugene for Azer-Cel and is eligible for a $7.5 million near-term clinical milestone from TG Therapeutics.
1 day ago
Precision BioSciences Details 2026 Clinical Milestones and Financial Runway
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences is advancing its clinical-stage programs, PBGENE-HBV for chronic hepatitis B and PBGENE-DMD for Duchenne Muscular Dystrophy, with data updates and initial patient data expected in 2026.
- The company anticipates IND clearance in Q1 2026 for PBGENE-DMD, with the first patient expected to be dosed in late Q1 or early Q2 2026 for its Phase 1/2 FUNCTION-DMD study.
- As of December 31, 2025, Precision BioSciences reported approximately $137 million in unaudited cash, cash equivalents, and restricted cash, which is anticipated to provide a cash runway through 2028.
- Precision received an $8 million milestone payment in the fourth quarter of 2025 from Imugene for Azer-Cel and is eligible for a $7.5 million near-term clinical milestone from TG Therapeutics for the same program.
3 days ago
Precision BioSciences' Licensed Technology Receives FDA RMAT Designation
DTIL
Product Launch
New Projects/Investments
- iECURE, which licensed the ARCUS® nuclease from Precision BioSciences (Nasdaq: DTIL), has been granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational therapy ECUR-506 for neonatal onset ornithine transcarbamylase (OTC) deficiency.
- The RMAT designation provides intensive FDA guidance and expedited review, potentially accelerating the development and regulatory pathway for ECUR-506.
- iECURE also achieved alignment with the FDA on the OTC-HOPE study design, which could support a Biologics License Application (BLA) for ECUR-506.
- Furthermore, ECUR-506 received an Innovation Passport under the United Kingdom’s Innovative Licensing and Access Pathway (ILAP).
8 days ago
Precision BioSciences Provides Update on Gene Editing Programs and Financial Runway
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences (DTIL) is focused on advancing two in-vivo gene editing programs: PBGene-HBV for hepatitis B and PBGene-DMD for Duchenne muscular dystrophy.
- The company recently completed a $75 million financing, which is expected to provide a cash runway through 2028.
- Initial Phase 1 data for PBGene-HBV, presented on November 10th, demonstrated dose-dependent antiviral activity and a manageable safety profile, with further data readouts anticipated in 2026.
- For PBGene-DMD, an Investigational New Drug (IND) application is expected to be filed in 2025, with patient enrollment in the clinic beginning in early 2026 and the first data readout by the end of 2026.
Dec 11, 2025, 2:15 PM
Precision BioSciences Provides Updates on Gene Editing Programs and Financing
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences (DTIL) is focused on advancing two in-vivo gene editing programs: PBGene-HBV for hepatitis B and PBGene-DMD for Duchenne muscular dystrophy.
- The company recently secured $75 million in financing, which is expected to provide a cash runway through 2028.
- For PBGene-HBV, phase 1 data presented on November 10th showed the drug is well-tolerated with dose-dependent antiviral activity, and further data readouts are anticipated in 2026.
- An Investigational New Drug (IND) application for PBGene-DMD is expected to be filed in 2025, with clinical trials commencing in early 2026 and first data readouts by the end of 2026. A Biologics License Application (BLA) for PBGene-DMD could potentially be filed by the end of 2028.
Dec 11, 2025, 2:15 PM
Precision BioSciences Updates on Gene Editing Programs and Cash Runway
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences (DTIL) is advancing two in-vivo gene editing programs: PBGENE-HBV for hepatitis B and PBGENE-DMD for Duchenne muscular dystrophy.
- The company recently raised $75 million, securing a cash runway through 2028 to fund these programs.
- For PBGENE-HBV, Phase 1 data presented on November 10th, 2025, demonstrated the drug was well tolerated with dose-dependent antiviral activity, with additional data readouts anticipated in 2026.
- The PBGENE-DMD program is on track for an Investigational New Drug (IND) filing by the end of 2025, with clinical trials starting in early 2026 and initial data expected by the end of 2026. A Biologics License Application (BLA) filing is targeted by the end of 2028.
Dec 11, 2025, 2:15 PM
Precision BioSciences Announces $75 Million Offering of Common Stock, Pre-Funded Warrants, and Warrants
DTIL
New Projects/Investments
- Precision BioSciences, Inc. (DTIL) announced an underwritten offering of 10,815,000 shares of common stock and accompanying warrants, along with pre-funded warrants to purchase up to 1,400,000 shares of common stock and accompanying warrants. The offering is expected to close on or about November 12, 2025.
- The combined offering price is $6.14 for common stock and warrants, and $6.139995 for pre-funded warrants and warrants. Each whole warrant has an exercise price of $7.25 per share and will expire five years following the date of issuance.
- The company anticipates gross proceeds of approximately $75 million and estimated net proceeds of approximately $70.0 million from the offering.
- Net proceeds will be used to fund ongoing and planned research and development, working capital, and general corporate purposes.
Nov 12, 2025, 2:12 PM
Precision BioSciences Reports Positive Clinical Data for HBV Program and Secures $75 Million in Funding
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences presented positive late-breaking data from its Eliminate B trial for PBG.001-HBV at AASLD, highlighting dose-dependent antiviral effects, a manageable safety profile, and the first clinical biopsy evidence of gene editing in HBV.
- The company anticipates that data from cohort three of the PBG.001-HBV trial indicates a near-term path towards stopping nucleos(t)ide analogs (nukes) and testing for a cure, with dosing for this cohort projected to conclude in Q1 2026.
- Precision BioSciences secured $75 million through a public offering, extending its operational runway through 2028 to fund the PBG.001-HBV program through Phase 2 and the PBG.001-DMD program through pivotal trials to BLA submission.
- The PBG.001-DMD program is on track for an IND filing by the end of 2025 and expects to dose its first patient in Q1 2026, with initial patient data anticipated by the end of 2026.
Nov 11, 2025, 1:00 PM
Precision BioSciences Provides Clinical Program Updates and Announces $75M Financing
DTIL
New Projects/Investments
Guidance Update
- Precision BioSciences announced a successful $75 million financing that extends its cash runway through 2028 to advance its lead programs, PBGENE-HBV and PBGENE-DMD.
- The company's wholly-owned PBGENE-HBV program for Chronic Hepatitis B has delivered 22 doses across 9 patients to date, demonstrating responses at all dose levels and an emerging path to expansion phase and Phase II earlier than anticipated.
- As of the October 31, 2025 data cutoff, all three patients in Cohort 3 of the PBGENE-HBV study at 0.8 mg/kg are showing deepening responses towards a benchmark for considering stopping NUCs.
- Precision BioSciences expects multiple clinical data readouts over the next 12-24 months, including initial PBGENE-HBV clinical data in 2025 and an IND filing for PBGENE-DMD in late 2025, with patient dosing projected for 2026.
Nov 11, 2025, 1:00 PM
Precision Biosciences Provides Clinical Update on HBV and DMD Programs, Announces $75 Million Public Offering
DTIL
Guidance Update
New Projects/Investments
- Precision Biosciences (DTIL) announced a public offering that raised $75,000,000, securing its cash and operational runway through 2028 to fund the Phase two HBV (ELIMINATE B trial) and the DMD pivotal to BLA submission.
- The ELIMINATE B trial for chronic hepatitis B (PBGene HBV) has demonstrated dose-dependent antiviral activity and improved durability across all three cohorts, with the 0.8 mg/kg dose in Cohort 3 showing a near-term path towards stopping NUCs and testing for cure.
- PBGene HBV has been well tolerated across all three cohorts with repeat administrations, with no dose-limiting toxicities observed and manageable, predictable adverse events in the ELIMINATE B study.
- First-ever clinical biopsy data from the ELIMINATE B trial revealed 28% editing (indel formation) in the viral DNA after two administrations at 0.4 mg/kg, providing proof of mechanism that PBGene HBV edits viral DNA in humans.
Nov 11, 2025, 1:00 PM
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