PBGENE-HBV Achieves Breakthrough in Chronic Hepatitis B Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Source: Newsfilter
- Clinical Data Breakthrough: New data demonstrate that PBGENE-HBV achieves a 1-log (10-fold) reduction in cccDNA, providing the first clinical evidence of its efficacy in liver biopsies from chronic hepatitis B patients, marking a significant advancement in the treatment field.
- Biomarker Confirmation: pgRNA has been established as a biomarker reflecting cccDNA elimination, with 100% of patients achieving pgRNA loss after treatment, showcasing the effectiveness and clear therapeutic window of PBGENE-HBV.
- Good Safety Profile: Among 38 doses administered, no dose-limiting toxicities were observed, with infusion-related reactions being the most common adverse events, indicating a favorable safety and tolerability profile for PBGENE-HBV.
- Future Development Directions: Precision plans to expand patient recruitment for the ELIMINATE-B trial, collecting additional biopsy data to support direct targeting and elimination of cccDNA, with further updates expected by the end of 2026 to drive a shift in chronic hepatitis B treatment.
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Analyst Views on DTIL
Wall Street analysts forecast DTIL stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 6.920
Low
30.00
Averages
45.00
High
60.00
Current: 6.920
Low
30.00
Averages
45.00
High
60.00
About DTIL
Precision BioSciences, Inc. is a clinical-stage gene editing company dedicated to improving life (DTIL) with its proprietary ARCUS genome editing platform. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver cures for a range of genetic and infectious diseases. The ARCUS platform is used to develop in vivo gene editing therapies for gene edits, including gene insertion, elimination, and excision. The Company's in vivo gene editing pipeline programs include PBGENE-HBV, PBGENE-3243, PBGENE-DMD, PBGENE-LIVER, PBGENE-CNS, PBGENE-NVS and iECURE-OTC. PBGENE-HBV is its lead in vivo gene editing program designed to eliminate cccDNA, the key source of replicating hepatitis B virus (HBV) and inactivating integrated HBV DNA in hepatocytes. Its PBGENE-3243 program is a first of its kind potential treatment for m.3243 associated mitochondrial disease. The Company's iECURE-OTC program is developed in partnership with iECURE, Inc.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Precision BioSciences Reveals Breakthrough Data in Hepatitis B Treatment
- Therapeutic Breakthrough: Precision BioSciences' ELIMINATE-B study reveals for the first time that PBGENE-HBV can directly eliminate and inactivate cccDNA in liver biopsies, achieving a 10-fold reduction in cccDNA transcripts post-treatment, marking a significant advancement in hepatitis B therapy.
- Biomarker Validation: The study validates pgRNA as a reliable biomarker for cccDNA elimination, with all patients showing complete loss of detectable pgRNA after treatment, alongside substantial declines in HBsAg, indicating strong antiviral activity.
- Safety Management: Across 38 doses administered to 16 patients, PBGENE-HBV demonstrated a manageable safety profile with common infusion-related reactions and no dose-limiting toxicities observed, highlighting the therapy's feasibility for broader application.
- Future Outlook: Precision BioSciences plans to expand patient enrollment and gather additional biopsy data to strengthen evidence of cccDNA elimination, while preparing for Part 2 of the ELIMINATE-B trial, with updates expected by the end of 2026.
See More
PBGENE-HBV Achieves Breakthrough in Chronic Hepatitis B Treatment
- Clinical Data Breakthrough: New data demonstrate that PBGENE-HBV achieves a 1-log (10-fold) reduction in cccDNA, providing the first clinical evidence of its efficacy in liver biopsies from chronic hepatitis B patients, marking a significant advancement in the treatment field.
- Biomarker Confirmation: pgRNA has been established as a biomarker reflecting cccDNA elimination, with 100% of patients achieving pgRNA loss after treatment, showcasing the effectiveness and clear therapeutic window of PBGENE-HBV.
- Good Safety Profile: Among 38 doses administered, no dose-limiting toxicities were observed, with infusion-related reactions being the most common adverse events, indicating a favorable safety and tolerability profile for PBGENE-HBV.
- Future Development Directions: Precision plans to expand patient recruitment for the ELIMINATE-B trial, collecting additional biopsy data to support direct targeting and elimination of cccDNA, with further updates expected by the end of 2026 to drive a shift in chronic hepatitis B treatment.
See More
Precision BioSciences to Host Webcast on Hepatitis B Clinical Data
- Webcast Announcement: Precision BioSciences will host an investor webcast on May 27, 2026, at 8:00 AM EDT to discuss new biopsy and clinical data from the ongoing ELIMINATE-B trial, which is expected to attract attention from investors and Hepatitis B experts, thereby enhancing the company's visibility in the biopharmaceutical sector.
- ELIMINATE-B Trial Progress: The trial is evaluating PBGENE-HBV as a potential curative treatment for chronic Hepatitis B and has received Fast Track designation from the FDA, indicating its innovative nature and market potential, which could present significant commercial opportunities for the company.
- Clinical Data Release: The webcast will showcase the latest clinical data and important biopsy results presented at the 2026 European Association for the Study of the Liver Congress, which will support the efficacy of PBGENE-HBV and further bolster investor confidence.
- Platform Advantages: PBGENE-HBV is the world's first gene editing program targeting the root cause of chronic Hepatitis B, cccDNA, aiming for a viral cure; if successful, it will establish Precision BioSciences as a leader in gene therapy, driving long-term growth.
See More
Preliminary Data on ECUR-506 Treatment for OTC Deficiency
- Significant Treatment Effects: As of April 20, 2026, 71% of the 7 participants treated with ECUR-506 experienced no hyperammonemic crises (HACs), indicating the therapy's potential to improve quality of life, particularly in neonates with OTC deficiency.
- Crisis Rate Reduction: Following ECUR-506 treatment, the annualized rate of HACs decreased by approximately 52%, from about 3.12 to 1.49 events per year, providing better survival and developmental opportunities for patients and underscoring the clinical significance of the new therapy.
- Good Safety Profile: ECUR-506 was generally well tolerated across all dose cohorts, with no unexpected safety events observed, aligning with expected safety characteristics, suggesting optimistic prospects for its application in high-risk populations.
- Clinical Trial Progress: Preliminary results from the OTC-HOPE trial support continued evaluation of ECUR-506's efficacy, with iECURE planning to further validate its effectiveness in upcoming pivotal trials, offering hope for infants affected by OTC deficiency.
See More
Precision BioSciences Q1 Earnings Report Analysis
- Earnings Performance: Precision BioSciences reported a Q1 GAAP EPS of -$0.75, missing expectations by $0.09, indicating challenges in profitability that may affect investor confidence.
- Revenue Growth: The company achieved Q1 revenue of $10.84M, a significant increase from $29K year-over-year, beating market expectations by $6.79M, demonstrating substantial progress in the commercialization of its gene editing technologies.
- Cash Reserves: As of March 31, 2026, Precision BioSciences holds a cash balance of $125.8M, including cash, cash equivalents, and restricted cash, providing financial stability for future clinical stage gene editing projects.
- Project Milestones: The company anticipates utilizing its cash reserves to support data milestones for its two wholly owned clinical stage gene editing programs, PBGENE-HBV and PBGENE-DMD, through 2028, reflecting the sustainability of its long-term strategic vision.
See More
Precision BioSciences to Announce Q1 Earnings on May 5
- Earnings Announcement Schedule: Precision BioSciences is set to release its Q1 2023 earnings report on May 5 before market open, with a consensus EPS estimate of -$0.81, reflecting a 63.3% year-over-year improvement, indicating efforts towards enhancing profitability.
- Revenue Expectations: Analysts forecast revenue of $4.05 million for the quarter, although the company has only beaten revenue estimates 25% of the time over the past year, suggesting ongoing challenges in revenue growth.
- Historical Performance Review: Over the past year, Precision BioSciences has exceeded EPS estimates 75% of the time, demonstrating relative stability in earnings forecasts, which may bolster investor confidence ahead of the upcoming report.
- Market Reaction Anticipation: As the earnings report approaches, investors will closely monitor the company's performance, particularly in the current economic climate, where any results exceeding expectations could positively impact the stock price.
See More
Precision BioSciences Reveals Breakthrough Data in Hepatitis B Treatment
- Therapeutic Breakthrough: Precision BioSciences' ELIMINATE-B study reveals for the first time that PBGENE-HBV can directly eliminate and inactivate cccDNA in liver biopsies, achieving a 10-fold reduction in cccDNA transcripts post-treatment, marking a significant advancement in hepatitis B therapy.
- Biomarker Validation: The study validates pgRNA as a reliable biomarker for cccDNA elimination, with all patients showing complete loss of detectable pgRNA after treatment, alongside substantial declines in HBsAg, indicating strong antiviral activity.
- Safety Management: Across 38 doses administered to 16 patients, PBGENE-HBV demonstrated a manageable safety profile with common infusion-related reactions and no dose-limiting toxicities observed, highlighting the therapy's feasibility for broader application.
- Future Outlook: Precision BioSciences plans to expand patient enrollment and gather additional biopsy data to strengthen evidence of cccDNA elimination, while preparing for Part 2 of the ELIMINATE-B trial, with updates expected by the end of 2026.
See More
PBGENE-HBV Achieves Breakthrough in Chronic Hepatitis B Treatment
- Clinical Data Breakthrough: New data demonstrate that PBGENE-HBV achieves a 1-log (10-fold) reduction in cccDNA, providing the first clinical evidence of its efficacy in liver biopsies from chronic hepatitis B patients, marking a significant advancement in the treatment field.
- Biomarker Confirmation: pgRNA has been established as a biomarker reflecting cccDNA elimination, with 100% of patients achieving pgRNA loss after treatment, showcasing the effectiveness and clear therapeutic window of PBGENE-HBV.
- Good Safety Profile: Among 38 doses administered, no dose-limiting toxicities were observed, with infusion-related reactions being the most common adverse events, indicating a favorable safety and tolerability profile for PBGENE-HBV.
- Future Development Directions: Precision plans to expand patient recruitment for the ELIMINATE-B trial, collecting additional biopsy data to support direct targeting and elimination of cccDNA, with further updates expected by the end of 2026 to drive a shift in chronic hepatitis B treatment.
See More
Precision BioSciences to Host Webcast on Hepatitis B Clinical Data
- Webcast Announcement: Precision BioSciences will host an investor webcast on May 27, 2026, at 8:00 AM EDT to discuss new biopsy and clinical data from the ongoing ELIMINATE-B trial, which is expected to attract attention from investors and Hepatitis B experts, thereby enhancing the company's visibility in the biopharmaceutical sector.
- ELIMINATE-B Trial Progress: The trial is evaluating PBGENE-HBV as a potential curative treatment for chronic Hepatitis B and has received Fast Track designation from the FDA, indicating its innovative nature and market potential, which could present significant commercial opportunities for the company.
- Clinical Data Release: The webcast will showcase the latest clinical data and important biopsy results presented at the 2026 European Association for the Study of the Liver Congress, which will support the efficacy of PBGENE-HBV and further bolster investor confidence.
- Platform Advantages: PBGENE-HBV is the world's first gene editing program targeting the root cause of chronic Hepatitis B, cccDNA, aiming for a viral cure; if successful, it will establish Precision BioSciences as a leader in gene therapy, driving long-term growth.
See More
Preliminary Data on ECUR-506 Treatment for OTC Deficiency
- Significant Treatment Effects: As of April 20, 2026, 71% of the 7 participants treated with ECUR-506 experienced no hyperammonemic crises (HACs), indicating the therapy's potential to improve quality of life, particularly in neonates with OTC deficiency.
- Crisis Rate Reduction: Following ECUR-506 treatment, the annualized rate of HACs decreased by approximately 52%, from about 3.12 to 1.49 events per year, providing better survival and developmental opportunities for patients and underscoring the clinical significance of the new therapy.
- Good Safety Profile: ECUR-506 was generally well tolerated across all dose cohorts, with no unexpected safety events observed, aligning with expected safety characteristics, suggesting optimistic prospects for its application in high-risk populations.
- Clinical Trial Progress: Preliminary results from the OTC-HOPE trial support continued evaluation of ECUR-506's efficacy, with iECURE planning to further validate its effectiveness in upcoming pivotal trials, offering hope for infants affected by OTC deficiency.
See More
Precision BioSciences Q1 Earnings Report Analysis
- Earnings Performance: Precision BioSciences reported a Q1 GAAP EPS of -$0.75, missing expectations by $0.09, indicating challenges in profitability that may affect investor confidence.
- Revenue Growth: The company achieved Q1 revenue of $10.84M, a significant increase from $29K year-over-year, beating market expectations by $6.79M, demonstrating substantial progress in the commercialization of its gene editing technologies.
- Cash Reserves: As of March 31, 2026, Precision BioSciences holds a cash balance of $125.8M, including cash, cash equivalents, and restricted cash, providing financial stability for future clinical stage gene editing projects.
- Project Milestones: The company anticipates utilizing its cash reserves to support data milestones for its two wholly owned clinical stage gene editing programs, PBGENE-HBV and PBGENE-DMD, through 2028, reflecting the sustainability of its long-term strategic vision.
See More
Precision BioSciences to Announce Q1 Earnings on May 5
- Earnings Announcement Schedule: Precision BioSciences is set to release its Q1 2023 earnings report on May 5 before market open, with a consensus EPS estimate of -$0.81, reflecting a 63.3% year-over-year improvement, indicating efforts towards enhancing profitability.
- Revenue Expectations: Analysts forecast revenue of $4.05 million for the quarter, although the company has only beaten revenue estimates 25% of the time over the past year, suggesting ongoing challenges in revenue growth.
- Historical Performance Review: Over the past year, Precision BioSciences has exceeded EPS estimates 75% of the time, demonstrating relative stability in earnings forecasts, which may bolster investor confidence ahead of the upcoming report.
- Market Reaction Anticipation: As the earnings report approaches, investors will closely monitor the company's performance, particularly in the current economic climate, where any results exceeding expectations could positively impact the stock price.
See More
