Precision BioSciences (NASDAQ: DTIL) shares HBV data, DMD trial timeline
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
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.
Positive
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Negative
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8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
HBV transcript reduction: 1-log (10-fold) reduction
Next HBV program update: Year-end 2026
Initial DMD safety data: Year-end 2026
+1 more
4 metrics
HBV transcript reduction
1-log (10-fold) reduction
cccDNA-derived transcripts in ELIMINATE-B study liver biopsies
Next HBV program update
Year-end 2026
Targeted timing for PBGENE-HBV update
Initial DMD safety data
Year-end 2026
Targeted timing for FUNCTION-DMD safety data
Clinical sites for FUNCTION-DMD
Second clinical site
Activation at Washington University School of Medicine
Key Terms
cccDNA, PBGENE-HBV, ELIMINATE-B, FUNCTION-DMD, +2 more
6 terms
cccDNA medical
"PBGENE-HBV directly eliminated cccDNA through its primary mechanism"
cccDNA is a stable, circular form of viral genetic material that can hide inside infected cells and act like a permanent backup copy the virus uses to keep making new virus particles. For investors, cccDNA matters because treatments that reduce or eliminate this hidden template are more likely to produce long-lasting cures, shape clinical trial success and regulatory decisions, and therefore affect a drug’s commercial value and a company’s prospects.
PBGENE-HBV medical
"PBGENE-HBV clinical highlights from its ELIMINATE-B study for chronic hepatitis B"
ELIMINATE-B medical
"PBGENE-HBV clinical highlights from its ELIMINATE-B study for chronic hepatitis B"
FUNCTION-DMD medical
"FUNCTION-DMD clinical trial evaluating PBGENE-DMD for Duchenne muscular dystrophy"
Duchenne muscular dystrophy medical
"FUNCTION-DMD clinical trial evaluating PBGENE-DMD for Duchenne muscular dystrophy"
A rare, inherited condition that progressively weakens muscles, Duchenne muscular dystrophy causes the body’s muscle fibers to break down over time, often leading to severe disability. For investors, it matters because the small, well-defined patient population, high unmet medical need and complex regulatory and pricing dynamics mean successes or failures in clinical trials, approvals, or therapies can have outsized effects on a company’s valuation and future revenue prospects.
forward-looking statements regulatory
"contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
FAQ
What did Precision BioSciences (DTIL) disclose about its hepatitis B program?
Precision BioSciences reported PBGENE-HBV liver biopsy data showing a 1-log (10-fold) reduction in cccDNA-derived transcripts. This indicates direct elimination of cccDNA in the ELIMINATE-B study, with the next program update targeted for year-end 2026.
What is PBGENE-HBV and what are the ELIMINATE-B study highlights?
PBGENE-HBV is Precision BioSciences’ candidate for chronic hepatitis B. In the ELIMINATE-B study, liver biopsy data showed PBGENE-HBV directly eliminated cccDNA, producing a 1-log (10-fold) reduction in cccDNA-derived transcripts. A further program update is targeted by year-end 2026.
What update did Precision BioSciences (DTIL) provide on its Duchenne muscular dystrophy trial?
Precision BioSciences announced activation of a second clinical site at Washington University School of Medicine for the FUNCTION-DMD trial of PBGENE-DMD. The company is targeting year-end 2026 for initial safety data from this Duchenne muscular dystrophy clinical trial.
Where can investors find Precision BioSciences’ updated corporate deck?
The updated Precision BioSciences corporate deck is available in the Investors section of its website at https://investor.precisionbiosciences.com. It summarizes clinical highlights, including PBGENE-HBV ELIMINATE-B data and progress on the FUNCTION-DMD trial for Duchenne muscular dystrophy.
Is the information about Precision BioSciences’ programs considered filed with the SEC?
No. The company states the information in the Regulation FD section is furnished, not filed, under the Securities Exchange Act. It is not subject to Section 18 liabilities and is only incorporated into other filings if specifically referenced.
What clinical timelines did Precision BioSciences specify for 2026?
Precision BioSciences is targeting year-end 2026 for two milestones: the next program update for PBGENE-HBV in chronic hepatitis B and initial safety data from the FUNCTION-DMD clinical trial evaluating PBGENE-DMD for Duchenne muscular dystrophy.