On August 6, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported financial results for the second quarter ended June 30, 2026, and provided a business update.
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"The second quarter marked a defining moment for Precision BioSciences and the hepatitis B field, with the first clinical biopsy evidence that a therapeutic agent can directly target and eliminate cccDNA – data that validate both the science and the development strategy for PBGENE-HBV," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "We also continued to advance PBGENE-DMD, with patients now being recruited to participate in the FUNCTION-DMD study. We entered 2026 with a clear plan to deliver multiple important clinical and operational milestones and we are executing against it with near-term data updates from both programs targeted for year end."
Wholly Owned Portfolio:
PBGENE-HBV (Hepatitis B Viral Elimination Program)
PBGENE-HBV is Precision’s wholly owned in vivo gene editing program being evaluated in ELIMINATE-B, a global clinical trial, as a potential curative treatment for chronic hepatitis B. PBGENE-HBV is the only clinical stage program that targets and eliminates cccDNA, the sole source of viral replication, leading to sustained loss of pgRNA, the precursor for HBV DNA. PBGENE-HBV is the first and only in vivo gene elimination approach to prospectively employ repeat administrations of lipid nanoparticle (LNP) in chronic hepatitis B with the goal of complete viral cure.
On May 27, 2026, Precision presented new and late-breaking clinical data from the ongoing ELIMINATE-B study at the European Association for the Study of the Liver (EASL) Congress 2026 in Barcelona, Spain. The data cut on May 4, 2026, was based on 38 doses administered across 16 patients in 5 cohorts.
Key Findings:
Liver biopsy data demonstrated a 1-log (10-fold) reduction in cccDNA-derived transcripts in one patient after only two administrations of PBGENE-HBV at 0.4 mg/kg, with less than 1% of cccDNA remaining post-treatment. Further biopsy analysis of a second patient, who received three doses at the same dose level and schedule, demonstrated that repeat administrations of PBGENE-HBV cumulatively increase the anti-cccDNA effect in the liver. Together, the biopsy data delivered the first ever clinical proof that a gene editor can directly target and eliminate cccDNA in chronic hepatitis B patients.
While molecular biopsies provide clear evidence of cccDNA editing, HBV pre-genomic RNA (pgRNA) is the best blood biomarker for cccDNA elimination. pgRNA is exclusively produced from cccDNA and is the only source of new infectious virions, measured in the blood as HBV DNA. Following treatment with PBGENE-HBV, pgRNA became durably undetectable in 100% of patients who had detectable pgRNA prior to treatment. Importantly, the loss of pgRNA was ongoing for up to six months as of the data cut-off. This sustained loss of pgRNA demonstrates the durability of PBGENE-HBV’s elimination mechanism designed to directly target and eradicate cccDNA.
In other important secondary serum biomarkers, substantial S-antigen declines were observed in 100% of patients treated, and durability was demonstrated in patients across all dose levels being investigated ranging from 0.2mg/kg to 0.8mg/kg. Additionally, the first patient dosed in the ELIMINATE-B trial continued to demonstrate substantial reductions more than one year after dosing.
No dose-limiting toxicities have been observed in 16 patients across five cohorts. The etiology of LNP-related hypotension observed during dose escalation was identified and ameliorated through straightforward mitigation measures such as a longer infusion time and a short course of steroids at the time of infusion.
Since the data update, Precision has opened new trial sites and continues enrolling additional patients, expanding cohorts 4 (0.4 mg/kg) and 5 (0.65 mg/kg), while collecting additional biopsies and blood biomarker data to further assess viral elimination. The current and future datasets are expected to inform selection of the optimal dosing schedule for Part 2 expansion. Precision continues its work with global investigators for next phase study design and expects to provide additional updates on the ELIMINATE-B trial progress by the end of 2026.
PBGENE-DMD (Muscle Targeted Gene Excision Program)
PBGENE-DMD is Precision’s development candidate for Duchenne muscular dystrophy (DMD) designed to durably improve function for approximately 60% of patients with DMD. By employing two complementary ARCUS nucleases in a single AAV, PBGENE-DMD excises exons 45-55 of the dystrophin gene, restoring expression of a near full-length dystrophin protein.
The company presented new preclinical data at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2026 Annual Meeting in Boston, Massachusetts. The new data showed that treatment with PBGENE-DMD in early-juvenile mice resulted in significantly higher efficacy across key skeletal and respiratory muscles than treatment in late-juvenile mice over a comparable timeframe. This new data further supports evaluating PBGENE-DMD in younger DMD patient populations, including the 2- to 3-year-old patients, who are a key demographic of the ongoing Phase 1/2 FUNCTION-DMD trial evaluating PBGENE-DMD in boys ages 2 to 7.
Precision continues to advance the Phase 1/2 FUNCTION-DMD clinical trial, with two clinical trial sites now active: Arkansas Children’s Hospital in Little Rock and Washington University School of Medicine in St. Louis, both recognized centers of excellence for DMD care.
The study is actively recruiting patients with initial safety data expected for year-end 2026.
Partnered In Vivo Programs:
iECURE-OTC (Gene Insertion Program)
Led by iECURE, Inc. (iECURE) ECUR-506 is an ARCUS-mediated in vivo targeted gene insertion program currently in a first-in-human trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal-onset ornithine transcarbamylase (OTC) deficiency. iECURE previously announced alignment with the FDA on key study elements that could support a potential Biologics License Application (BLA). The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain.
iECURE presented clinical data at the ASGCT (Free ASGCT Whitepaper) Annual Meeting in May, including preliminary data from study participants in the first three dose cohorts (n=7) of the ongoing OTC-HOPE study, and demonstrated that 71% of participants experienced no hyperammonemic crises following ECUR-506 administration. In addition, iECURE presented a poster at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in May 2026 featuring one-year post-treatment data from the first infant dosed in the study who achieved a complete clinical response as defined by study protocol.
Partnered Ex Vivo Programs:
Azer-cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Cancer)
Imugene Limited continues development of azer-cel in diffuse large B-cell lymphoma and has received written guidance from the FDA regarding the registrational pathway for azer-cel. The guidance provided clear alignment with the FDA across key elements required to support advancement into a pivotal study, including dosing regimen, patient population, endpoints, and manufacturing readiness. Azer-cel data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May 2026 demonstrated that among 24 patients evaluable for response following their first disease assessment at Day 28, response rates ranging from 50%-100% were observed across all six cancer subtypes.
Azer-cel (Azercabtagene Zapreleucel Allogeneic CAR T Treatment for Multiple Sclerosis)
Separately, azer-cel is being evaluated by TG Therapeutics, Inc. (Nasdaq: TGTX) in a Phase 1 trial in progressive multiple sclerosis. In April 2026, Precision received a clinical milestone cash payment under its license agreement with TG Therapeutics. The payment of $7.5 million was inclusive of $5.25 million cash and $2.25 million for the purchase of shares of Precision common stock by TG Therapeutics.
Corporate Developments:
Precision announced changes to its senior leadership team to support advancement of its programs through the next set of clinical milestones. On August 1, 2026, Alex Kelly, formerly Chief Financial Officer, was promoted to the newly created role of Chief Operating Officer where he will oversee all key customer-facing functions. Naresh Tanna, formerly Vice President of Investor Relations and Chief of Staff to the CEO, was promoted to Chief Financial Officer where he will oversee corporate finance, reporting and investor relations. In addition, Cassie Gorsuch, PhD, Chief Scientific Officer, now leads all research functions, including clinical stage translational sciences and next generation programs.
Precision announced its addition to the Russell 2000 Index, effective at the close of U.S. equity markets on June 26, 2026, according to the final list of additions published by FTSE Russell expanding market visibility with institutional investors.
Quarter Ended June 30, 2026 Financial Results:
Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2026, Precision had approximately $112.4 million in cash, cash equivalents, and restricted cash. The Company expects that existing cash and cash equivalents, continued fiscal and operating discipline, and availability of Precision’s at-the-market facility will fund the Company’s cash runway through 2028. Based on its expected cash runway, Precision believes it is sufficiently capitalized to achieve PBGENE-HBV and PBGENE-DMD data milestones through 2028.
Revenues: As expected, no revenue was reported for the quarter ended June 30, 2026 compared to less than $0.1 million for the quarter ended June 30, 2025. Revenue from the prior period was recognized from the Novartis Agreement.
Research and Development Expenses: Research and development expenses were $12.4 million for the quarter ended June 30, 2026, as compared to $12.8 million for the quarter ended June 30, 2025. The decrease of $0.4 million was primarily due to decreases in platform development and research expenses, partially offset by increases in PBGENE-DMD and PBGENE-HBV clinical program costs as the programs continue to advance globally.
General and Administrative Expenses: General and administrative expenses were $6.8 million for the quarter ended June 30, 2026, as compared to $9.1 million for the quarter ended June 30, 2025. The decrease of $2.3 million was primarily a result of operational discipline and lower employee-related costs.
Other Expense: Total other expense was $13.5 million for the quarter ended June 30, 2026, compared to $1.6 million total other expense for the quarter ended June 30, 2025. The increase of $11.9 million was primarily due to non-cash fair value adjustments, primarily from the loss on change in fair value of the warrant liability. Precision’s stock price appreciation as compared to the prior measurement period resulted in an increase in warrant liability and a corresponding non-cash loss. This loss does not impact operating loss or cash runway.
Net Loss: Net loss was $32.7 million, or $(1.26) per share (basic and diluted), for the quarter ended June 30, 2026. Net loss was $23.5 million, or $(2.13) per share (basic and diluted), for the quarter ended June 30, 2025. This increase in net loss compared to the prior period is primarily driven by the non-cash loss from the warrant liability and does not affect loss from operations or cash runway.
About Chronic Hepatitis B
Chronic hepatitis B virus causes inflammation and damage to the liver, leading to chronic infection and increased risk of death from liver cancer or cirrhosis. There is no cure for chronic hepatitis B, and current treatments rarely result in a functional cure, primarily due to persistence of viral DNA in the liver. In patients with chronic hepatitis B, genetic material of the virus is converted within infected liver cells into cccDNA that acts as the only template to make new infectious viral particles. Hepatitis B virus also inserts fragments of its DNA into the human genome of infected liver cells. These integrated fragments are viral replication incompetent and cannot produce new infectious virus. Both cccDNA and integrated HBV DNA produce the viral protein, hepatitis B surface antigen (HBsAg), which is secreted in the blood.
Historically, the focus for drug development and regulatory approval of drugs for chronic hepatitis B has relied on the temporary suppression of HBsAg. Achieving undetectable HBsAg may lead to a functional cure if there is no rebound in HBV DNA or HBsAg after drug treatment has been discontinued for at least six months, but this is achieved in less than three out of 100 patients treated with the current standard of care. Since cccDNA is the only source of infectious particles (HBV DNA), elimination of cccDNA results in a viral cure of chronic hepatitis B. Sustained loss of HBV DNA alone as a result of cccDNA elimination is an approvable endpoint for the FDA and highly relevant for PBGENE-HBV.
About PBGENE-HBV, A Viral Elimination Program
PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic hepatitis B, cccDNA, while inactivating integrated HBV DNA. Elimination of cccDNA results in HBV viral cure as cccDNA is the only source of infectious replication (HBV DNA). The ELIMINATE-B trial is investigating PBGENE-HBV at multiple dose levels across a number of administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Fast Track designation by the FDA. The FDA has previously provided guidance that sustained loss of HBV DNA is an approvable endpoint for chronic hepatitis B.
Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT06680232.
About PBGENE-DMD, A Muscle-Targeted Excision Program
PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for approximately 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. Compared with DMD, deletion of exons 45-55 is often associated with a milder prognosis for patients. The aim of this approach is to restore a near full-length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated microdystrophin approaches with minimal functional benefit. The Phase 1/2 FUNCTION-DMD study is expected to enroll ambulatory DMD patients with mutations between exons 45 and 55. The clinical trial will employ an appropriate immune modulation regimen and safety monitoring program to treat ambulatory patients at world class specialized DMD clinical sites.
PBGENE-DMD was granted Orphan Drug Designation by the FDA in July 2025. The PBGENE-DMD program is eligible for a Priority Review Voucher (PRV) via the Rare Pediatric Disease Priority Review Voucher (PRV) program, which was signed into law on February 3, 2026, as part of the Consolidated Appropriations Act of 2026. PBGENE-DMD received Fast Track designation from the FDA in February 2026.
Further details on the trial can be found on Precision’s website and on clinicaltrials.gov identifier NCT07429240.
(Press release, Precision Biosciences, AUG 6, 2026, View Source [SID1234669801])