PRECISION BIOSCIENCES INC
For the period ended Sep 30, 2026. Filed Nov 3, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 3, 2026
DTIL$10.60+7.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001628280-26-053837
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-03.
0001628280-26-069092
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 133 previous paragraphs and 132 current paragraphs.
81 unchanged; 37 reworded; 10 added; 15 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
During the third quarter, we continued to advance the ELIMINATE-B trial, enrolling additional patients and expanding the 0.4 mg/kg and 0.65 mg/kg cohorts to support selection of the optimal dosing schedule for Phase 2 expansion. Additional biopsies and blood biomarker data are being collected to further validate and characterize cccDNA elimination findings demonstrated in the late-breaking EASL data presented in May 2026.
Current report
In October 2026, we announced that the PBGENE-HBV abstract had been selected for the late-breaking oral presentation at the upcoming Liver Meeting 2026 during the 77th annual meeting of the American Association for the Study of Liver Diseases. The embargoed abstract will become public on November 5, 2026 and the late-breaking oral presentation will occur on November 8, 2026.
Current report
In August 2026, we dosed the first patient in the Phase 1/2 FUNCTION-DMD study at Arkansas Children's Hospital, a PPMD-certified Duchenne Care Center and designated MDA Care Center in Little Rock, marking the first time a clinical stage gene editing approach aimed at restoring near full length dystrophin protein from the native gene has been evaluated in patients with DMD. Multiple clinical trial sites are now active, with Washington University School of Medicine in St. Louis also recruiting patients. The study is enrolling ambulatory DMD patients between the ages of 2 and 7 with mutations between exons 45 and 55, representing up to 60% of boys living with DMD. Initial safety data are targeted for year-end 2026, with efficacy data at distinct timepoints expected to follow in the first and second half of 2027.
Current report
In August 2026, iECURE presented updated clinical data in an oral platform presentation at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism in Helsinki, Finland. Preliminary safety observations showed ECUR-506 was generally well tolerated, with no unexpected treatment-related safety events observed. Phase 1/2 dosing has been completed across all dose cohorts and participant evaluations are ongoing. Updated low-dose cohort data demonstrated a 57% reduction in the annualized rate of hyperammonemic events (“HAEs”) and a 74% reduction in annualized hyperammonemic crises (“HACs”) following ECUR-506 administration. HAEs are episodes of elevated ammonia, with more severe episodes known as HACs. HACs are acute medical emergencies characterized by elevated ammonia levels with neurologic symptoms and can lead to hospitalization, irreversible neurologic injury, and death.
Current report
Partnered Ex Vivo Programs
Current report
Azer-cel is being evaluated by TG Therapeutics, Inc. (“TG Therapeutics”) in a Phase 1 trial in progressive multiple sclerosis (“MS”). TG Therapeutics presented a late-breaking oral presentation highlighting initial results from the Phase 1 azer-cel study in patients with primary progressive multiple sclerosis at the 10th Joint ACTRIMS-ECTRIMS Meeting, also referred to as MSToronto2026, on October 23, 2026, in Toronto, Canada. Across dose levels evaluated to date, azer-cel showed an encouraging preliminary safety profile with no high-grade CAR-T associated toxicities observed. Additionally, 89% of evaluable participants had stable or improved disability scores at Day 90, despite documented progression prior to enrollment on high-efficacy therapies. Early pharmacokinetics/pharmacodynamics, biomarker, and clinical outcomes support continued evaluation of azer-cel inprogressive MS.
Current report
Research and development expenses for the three months ended September 30, 2026 were $12.7 million, compared to $13.4 million for the three months ended September 30, 2025. The decrease of approximately $0.7 million was primarily due to reductions in research including completion of pre-investigational new drug (“IND”) research expenses for both the PBGENE-HBV and PBGENE-DMD programs, partially offset by an increase in the PBGENE-HBV clinical program costs driven by advancement and cohort expansion of the Phase 1 ELIMINATE-B trial.
Current report
Loss from Equity Method Investment
Current report
Gain on Disposal of Assets
Current report
Comparison of the Nine Months Ended September 30, 2026 and September 30, 2025
Removed paragraphs (15)
Previous report
On May 27, 2026, we 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 five cohorts.
Previous report
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 proof that a gene editor can directly target and eliminate cccDNA in chronic hepatitis B patients.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
Since the data update, we have opened new trial sites and continue 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. We continue our work with global investigators for next phase study design and expect to provide additional updates on the ELIMINATE-B trial progress by the end of 2026.
Previous report
We presented new preclinical data at the American Society of Gene & Cell Therapy (“ASGCT”) 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.
Previous report
We continue to advance the Phase 1/2 FUNCTION-DMD clinical trial, with two clinical trial sites now active: Arkansas Children's Hospital and Washington University School of Medicine, both recognized centers of excellence for DMD care.
Previous report
The study is actively recruiting patients with initial safety data expected for year-end 2026.
Previous report
iECURE presented clinical data at ASGCT in May 2026, 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.
Previous report
Non-Core Ex Vivo Programs
Previous report
The decrease in platform development and early-stage research expenses of $1.1 million was primarily the result of a decrease in licensing fees and other research and development costs as well as reduced lab supply expenses and facility-related costs as a result of reduced headcount. Direct expenses in PBGENE-HBV increased by $0.7 million, driven by translational assay development expenses and an increase in clinical material manufacturing.
Previous report
Comparison of the Six Months Ended June 30, 2026 and June 30, 2025
Previous report
Research and development expenses for the six months ended June 30, 2026 were $25.5 million, compared to $26.4 million for the six months ended June 30, 2025. The decrease of $0.9 million was primarily due to a $3.4 million decrease in platform development and early-stage research expenses, partially offset by a $2.5 million increase in our direct expenses in PBGENE-HBV and PBGENE-DMD as the clinical programs continue to advance globally.
Previous report
Gain from Equity Method Investment
Reworded paragraphs (37)
Previous wording
PBGENE-HBV is our wholly ownedin vivo gene editing program under investigation in a global clinical trial, ELIMINATE-B, which is designed to be a potentially curative treatment for chronic hepatitis B infection. PBGENE-HBV targets and eliminates covalently closed circular DNA (“cccDNA”), the sole source of viral replication, leading to sustained loss of pre-genomic RNA (“pgRNA”), the precursor for hepatitis B virus (“HBV”) DNA. PBGENE-HBV is the first and onlyin vivo gene elimination approach to prospectively employ repeat administrations of lipid nanoparticle (“LNP”) in chronic hepatitis B with the goal of complete viral cure.
Current wording
PBGENE-HBV is our wholly ownedin vivo gene editing program being evaluated in ELIMINATE-B, a global clinical trial, as a potential viral cure for chronic hepatitis B. PBGENE-HBV targets and eliminates covalently closed circular DNA (“cccDNA”), the sole source of viral replication, leading to durable loss of pregenomic RNA, the precursor for hepatitis B virus (“HBV”) DNA infectious particles. PBGENE-HBV is the first and onlyin vivo gene elimination approach to prospectively employ repeat lipid nanoparticle administration in chronic hepatitis B with the goal of viral elimination and viral cure.
Previous wording
PBGENE-DMD is our wholly-owned development candidate for Duchenne muscular dystrophy, or DMD. PBGENE-DMD is designed to durably improve function for approximately 60% of patients with DMD. By employing two complementary ARCUS nucleases in a single adeno-associated virus (“AAV”), PBGENE-DMD excises exons 45-55 of the dystrophin gene, restoring expression of a near full-length dystrophin protein.
Current wording
PBGENE-DMD is our investigational drug for Duchenne muscular dystrophy (“DMD”), designed to restore near full-length functional dystrophin protein through a gene excision approach using two ARCUS nucleases delivered in a single adeno-associated virus (“AAV”). We believe this approach of restoring the body’s native dystrophin gene after excising the frequently-mutated hotspot region including exons 45-55 may be applicable for the majority of patients with DMD.
Previous wording
In partnership with 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 U.S. Food and Drug Administration (“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.
Current wording
In partnership with iECURE, ECUR-506 is an ARCUS-mediatedin 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 U.S. Food and Drug
Previous wording
Separately, azer-cel is being evaluated by TG Therapeutics (Nasdaq: TGTX) in a Phase 1 trial in progressive multiple sclerosis. We previously announced the achievement of a clinical milestone under our license agreement with TG Therapeutics. As a result, we have earned a cash payment of $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of our common stock by TG Therapeutics at $11.17 per share.
Current wording
We previously announced the achievement of a clinical milestone under our license agreement with TG Therapeutics. As a result, we have earned a cash payment of $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of our common stock by TG Therapeutics at $11.17 per share.
Previous wording
Imugene 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 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.
Current wording
Separately, Imugene 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.
Previous wording
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our product candidates. These include the following:
Current wording
Research and development expenses consist primarily of costs incurred for our clinical trials and research activities, including our discovery efforts and the development of our product candidates. These include the following:
Previous wording
•the scope, rate of progress, expense and results of future clinical trials of our product candidates and other research and development activities that we may conduct;
Current wording
•the scope, rate of progress, expense and results of current and future clinical trials of our product candidates and other research and development activities that we may conduct;
Previous wording
Due to the pause in development of PBGENE-3243 to prioritize our two lead programs, PBGENE-HBV and PBGENE-DMD, expenses for PBGENE-3243 have been recast for the periods presented below. The amounts previously reporting under “PBGENE-3243 external development costs” are now reported within the “Platform development and early-stage research expense” line item.
Current wording
Due to the pause in development of PBGENE-3243 to prioritize our two lead programs, PBGENE-HBV and PBGENE-DMD, expenses for PBGENE-3243 have been recast for the periods presented below. The amounts previously reported under “PBGENE-3243 external development costs” are now reported within the “Platform development and early-stage research expense” line items.
Previous wording
General and administrative expenses were $13.6 million for the six months ended June 30, 2026, compared to 17.7 million for the six months ended June 30, 2025. The decrease of approximately $4.1 million was primarily a result of operational discipline and lower employee-related costs.
Current wording
General and administrative expenses were $7.7 million for the three months ended September 30, 2026, compared to $7.3 million for the three months ended September 30, 2025. The increase of approximately $0.4 million was primarily a result of increases in employee-related costs and consulting services.
Previous wording
For the three months ended June 30, 2025, the $0.7 million non-cash gain from equity investment was the result of a $2.3 million gain recorded from our proportionate share of Elo’s proceeds from a Series A-2 financing in such period, partially offset by our proportionate share of Elo’s loss. In the three months ended June 30, 2026, Elo was not classified as an equity method investment. There were no changes to the investment value for the three months ended June 30, 2026 and any subsequent changes in the investment’s fair value will be recorded through other fair value adjustments.
Current wording
For the three months ended September 30, 2025, the $0.6 million non-cash loss from equity investment was the result of our proportionate share of Elo’s loss under equity method accounting. In the three months ended September 30, 2026, Elo was not classified as an equity method investment. There were no changes to the investment value for the three months ended September 30, 2026 and any subsequent changes in the investment’s fair value will be recorded through other fair value adjustments.
Previous wording
The loss on changes in other fair value adjustments of $0.2 million for the three months ended June 30, 2026 is attributable to the non-cash decrease in fair value on the ordinary shares held for Imugene Limited. The loss on changes in other fair value adjustments of $2.5 million for the three months ended June 30, 2025 was primarily attributable to the non-cash decrease in fair value of the iECURE investment.
Current wording
The loss on changes in other fair value adjustments of $0.5 million for the three months ended September 30, 2026 is attributable to the non-cash decrease in fair value on the ordinary shares held for Imugene Limited. The loss on changes in other fair value adjustments of less than $0.1 million for the three months ended September 30, 2025 was primarily attributable to the change in fair value of the final payment fee under the 2024 Term Loan.
Previous wording
Loss on Change in Fair Value of Warrant Liability
Current wording
Gain (Loss) on Change in Fair Value of Warrant Liability
Previous wording
The non-cash loss from change in fair value of the warrant liability was $13.9 million for the three months ended June 30, 2026 compared to a non-cash gain of $0.8 million for the three months ended June 30, 2025 which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering and November 2025 Public Offering.
Current wording
The non-cash gain from change in fair value of the warrant liability was $12.7 million for the three months ended September 30, 2026 compared to a non-cash loss of $1.2 million for the three months ended September 30, 2025 represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering and November 2025 Public Offering.
Previous wording
Interest income was $0.9 million during the three months ended June 30, 2026 compared to $1.1 million during the three months ended June 30, 2025. The decrease of approximately $0.2 million was primarily driven by the Elo note receivable interest accrued for in the prior year as well as declining interest rates which was partially offset by a higher cash balance for the current period.
Current wording
Interest income was $0.9 million during the three months ended September 30, 2026 compared to $1.0 million during the three months ended September 30, 2025. The decrease of approximately $0.1 million was primarily driven by the Elo note receivable interest accrued for in the prior year as well as declining interest rates which was partially offset by a higher cash balance for the current period.
Previous wording
Gain on disposal of assets was less than $0.1 million during the six months ended June 30, 2026 compared to the loss on disposal of assets of less than $0.1 million during the six months ended June 30, 2025.
Current wording
There was no gain or loss on disposal of assets during the three months ended September 30, 2026 compared to the gain on disposal of assets of less than $0.1 million during the three months ended September 30, 2025.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026 and June 30, 2025, together with the changes in those items:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026 and September 30, 2025, together with the changes in those items:
Previous wording
Revenue for the six months ended June 30, 2026 was $10.8 million compared to less than $0.1 million for the six months ended June 30, 2025. Revenue from the prior period was generated from the Novartis Agreement. The increase in revenue was the result of revenue recognized under the TG License Agreement and a legacy ARCUS agriculture gene editing agreement during the six months ended June 30, 2026.
Current wording
Revenue for the nine months ended September 30, 2026 was $10.8 million compared to less than $0.1 million for the nine months ended September 30, 2025. Revenue from the prior period was generated from the Novartis Agreement. The increase in revenue during the nine months ended September 30, 2026 was the result of revenue recognized under the TG License Agreement and a legacy ARCUS agriculture gene editing agreement.
Previous wording
Research and development expenses for the three months ended June 30, 2026 were $12.4 million, compared to $12.8 million for the three months ended June 30, 2025. The decrease of $0.4 million was primarily due to a $1.1 million decrease in platform development and early-stage research expenses, partially offset by a $0.7 million increase in our direct expenses in PBGENE-HBV and PBGENE-DMD as the clinical programs continue to advance globally.
Current wording
Research and development expenses for the nine months ended September 30, 2026 were $38.2 million, compared to $39.7 million for the nine months ended September 30, 2025. The decrease of $1.5 million was primarily due to reductions in research including completion of pre-IND research expenses for both the PBGENE-HBV and PBGENE-DMD programs, partially offset by an increase in our direct expenses in PBGENE-HBV and PBGENE-DMD program costs.
Previous wording
The decrease in platform development and early-stage research expenses of $3.4 million was primarily the result of paused development of the PBGENE-3243 program as well as a reduction in employee-related costs. Direct expenses in PBGENE-DMD increased by $1.7 million as we initiated Institutional Review Board (“IRB”) activities and clinical trial site activation for the FUNCTION-DMD Phase 1/2 clinical trial, and direct expenses in PBGENE-HBV increased by $0.9 million due to translational assay development expenses and an increase in clinical material manufacturing.
Current wording
The decrease in platform development and early-stage research expenses of $5.2 million was primarily the result of paused development of the PBGENE-3243 program as well as a reduction in employee-related costs. Direct expenses in PBGENE-DMD increased by $1.5 million as we activated clinical trial sites for the FUNCTION-DMD Phase 1/2 clinical trial, and direct expenses in PBGENE-HBV increased by $2.3 million as we continue to advance the Phase 1 ELIMINATE-B clinical trial.
Previous wording
General and administrative expenses were $6.8 million for the three months ended June 30, 2026, compared to $9.1 million for the three months ended June 30, 2025. The decrease of approximately $2.3 million was primarily a result of operational discipline and lower employee-related costs.
Current wording
General and administrative expenses were $21.3 million for the nine months ended September 30, 2026, compared to $25.0 million for the nine months ended September 30, 2025. The decrease of approximately $3.7 million was primarily a result of operational discipline and lower employee-related costs.
Previous wording
For the six months ended June 30, 2025, the $0.7 million non-cash gain from equity investment was the result of a $2.3 million gain recorded from our proportionate share of Elo’s proceeds from a Series A-2 financing in such period, partially offset by our proportionate share of Elo’s loss over the period. In the six months ended June 30, 2026, Elo was not classified as an equity method investment. There were no changes to the investment value for the six months ended June 30, 2026 and any subsequent changes in the investment’s fair value will be recorded through other fair value adjustments.
Current wording
For the nine months ended September 30, 2025, the $0.1 million non-cash gain from equity investment was the result of a $2.3 million gain recorded from our proportionate share of Elo’s proceeds from a Series A-2 financing in such period, partially offset by our proportionate share of Elo’s loss over the period. In the nine months ended September 30, 2026, Elo was not classified as an equity method investment. There were no changes to the investment value for the nine months ended September 30, 2026 and any subsequent changes in the investment’s fair value will be recorded through other fair value adjustments.
Previous wording
The non-cash loss on changes in other fair value adjustments was $3.2 million for the six months ended June 30, 2026, which is attributable to the decrease in fair value on the ordinary shares held for Imugene Limited. The non-cash loss on changes in other fair value adjustments was $2.4 million for the six months ended June 30, 2025, which was primarily attributable to the decrease in fair value of the iECURE investment in the prior period.
Current wording
The non-cash loss on changes in other fair value adjustments was $3.7 million for the nine months ended September 30, 2026, which is attributable to the decrease in fair value on the ordinary shares held for Imugene Limited. The non-cash loss on changes in other fair value adjustments was $2.4 million for the nine months ended September 30, 2025, which was primarily attributable to the decrease in fair value of the iECURE investment in the prior period.
Previous wording
The non-cash loss from change in fair value of the warrant liability was $21.0 million for the six months ended June 30, 2026 compared to a non-cash loss of $0.1 million for the six months ended June 30, 2025, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering and November 2025 Public Offering.
Current wording
The non-cash loss from change in fair value of the warrant liability was $8.3 million for the nine months ended September 30, 2026 compared to a non-cash loss of $1.2 million for the nine months ended September 30, 2025, which represents the mark-to-market fair value adjustment to the outstanding warrants issued in connection with the March 2024 Public Offering and November 2025 Public Offering.
Previous wording
Interest expense was $0.6 million for the six months ended June 30, 2026 compared to $0.7 million for the six months ended June 30, 2025 primarily driven by declining interest rates on the 2024 Term Loan over the comparison period.
Current wording
Interest expense was $0.9 million for the nine months ended September 30, 2026 compared to $1.1 million for the nine months ended September 30, 2025 primarily driven by declining interest rates on the 2024 Term Loan over the comparison period.
Previous wording
Interest income was $1.9 million during the six months ended June 30, 2026 compared to $2.4 million during the six months ended June 30, 2025. The decrease of approximately $0.5 million was primarily driven by the Elo note receivable interest accrued for in the prior year as well as declining interest rates which was partially offset by a higher cash balance for the current period.
Current wording
Interest income was $2.8 million during the nine months ended September 30, 2026 compared to $3.5 million during the nine months ended September 30, 2025. The decrease of approximately $0.7 million was primarily driven by the Elo note receivable interest accrued for in the prior year as well as declining interest rates which was partially offset by a higher cash balance for the current period.
Previous wording
Gain on disposal of assets was less than $0.1 million during the three months ended June 30, 2026 compared to the loss on disposal of assets of less than $0.1 million during the three months ended June 30, 2025.
Current wording
Gain on disposal of assets was less than $0.1 million during the nine months ended September 30, 2026 compared to the loss on disposal of assets of less than $0.1 million during the nine months ended September 30, 2025.
Previous wording
We have incurred significant operating losses since our inception and have not generated any revenue from the sale of products. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates or the product candidates of our collaborators or other licensees for which we may receive milestone payments or royalties. As of June 30, 2026, we had an accumulated deficit of $579.3 million.
Current wording
We have incurred significant operating losses since our inception and have not generated any revenue from the sale of products. Our ability to generate any product revenue or product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates or the product candidates of our collaborators or other licensees for which we may receive milestone payments or royalties. As of September 30, 2026, we had an accumulated deficit of $586.9 million.
Previous wording
As of June 30, 2026, we had $112.4 million of cash, cash equivalents, and restricted cash under the 2024 Term Loan and compensatory arrangements with certain of our officers, respectively. Refer to Note 4, Commitments and Contingencies, in the accompanying notes to the financial statements for more information on these compensatory arrangements. Pursuant to our July 31, 2024 amended and restated loan and security agreement with Banc of California (the “2024 Loan and Security Agreement”), we are not entitled to borrow any additional amounts under the 2024 Term Loan and are required to maintain an aggregate balance in a cash security account with Banc of California (the “Cash Security Account”) at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Current wording
As of September 30, 2026, we had $108.0 million of cash, cash equivalents, and restricted cash under the 2024 Term Loan and compensatory arrangements with certain of our officers. Refer to Note 4, Commitments and Contingencies, in the accompanying notes to the financial statements for more information on these compensatory arrangements. Pursuant to our July 31, 2024 amended and restated loan and security agreement with Banc of California, as amended (the “2024 Loan and Security Agreement”), we are not entitled to borrow any additional amounts under the 2024 Term Loan and are required to maintain an aggregate balance in a cash security account with Banc of California (the “Cash Security Account”) at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Previous wording
Our cash, cash equivalents, and restricted cash totaled $112.4 million and $84.8 million as of June 30, 2026 and June 30, 2025, respectively.
Current wording
Our cash, cash equivalents, and restricted cash totaled $108.0 million and $71.2 million as of September 30, 2026 and September 30, 2025, respectively.
Previous wording
Cash used in operating activities during the six months ended June 30, 2026 was $25.4 million compared to $39.3 million during the six months ended June 30, 2025. The $13.9 million decrease in cash used in operating activities was driven by lower operating expenditures compared to the prior period as well as an increase of $20.3 million in non-cash adjustments, partially offset by a $7.0 million increase in net loss and $0.7 million in changes in operating assets and liabilities.
Current wording
Cash used in operating activities during the nine months ended September 30, 2026 was $40.5 million compared to $54.6 million during the nine months ended September 30, 2025. The $14.1 million decrease in cash used in operating activities was driven by lower operating expenditures compared to the prior period, an increase of $7.1 million in non-cash adjustments and a $7.2 million decrease in net loss. The decrease was partially offset by $0.2 million in changes in operating assets and liabilities over the comparison period.
Previous wording
The increase in non-cash adjustments was primarily driven by the net change in fair value of warrants during the six months ended June 30, 2026 compared to during the six months ended June 30, 2025. Also contributing to the increase in non-cash adjustments was the change in fair value of the Imugene ordinary shares during the six months ended June 30, 2026 and the gain on equity method investment of the Elo note in six months ended June 30, 2025.
Current wording
The increase in non-cash adjustments was primarily driven by the net change in fair value of warrants during the nine months ended September 30, 2026 compared to during the nine months ended September 30, 2025. Also contributing to the increase in non-cash adjustments was the change in fair value of the Imugene ordinary shares during the nine months ended September 30, 2026.
Previous wording
Cash used in investing activities primarily relates to cash expenditures to acquire leasehold additions, equipment, software and intangible assets. Net cash used in investing activities during the six months ended June 30, 2026 was $0.1 million, compared to $0.3 million used in investing activities in the six months ended June 30, 2025. The decrease in cash used in investing activities was primarily the result of a $0.2 million decrease in intangible asset purchases during the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Current wording
Cash used in investing activities primarily relates to cash expenditures to acquire leasehold additions, equipment, software and intangible assets. Net cash used in investing activities was $0.3 million in each of the nine months ended September 30, 2025 and nine months ended September 30, 2026 and was used for intangible asset purchases.
Previous wording
Net cash provided by financing activities during the six months ended June 30, 2026 was $0.7 million, compared to $16.0 million during the six months ended June 30, 2025. The $15.3 million decrease in cash provided by financing activities during the six months ended June 30, 2026 was primarily due to $14.8 million in net proceeds from the issuance of common stock through the Company's ATM facility during the six months ended June 30, 2025, whereas there were no proceeds from the issuance of common stock through the Company's ATM facility during the six months ended June 30, 2026.
Current wording
Net cash provided by financing activities during the nine months ended September 30, 2026 was $11.7 million, compared to $17.6 million during the nine months ended September 30, 2025. The $5.9 million decrease in cash provided by financing activities during the nine months ended September 30, 2026 was primarily due to $16.4 million in net proceeds from the issuance of common stock through our ATM facility during the nine months ended September 30, 2025 compared to $10.9 million in net proceeds from the issuance of common stock through our ATM facility during the nine months ended September 30, 2026.
Previous wording
The stated interest rate under the 2024 Term Loan is equal to the greater of 1.50% below the Prime Rate or 4.5%. As of June 30, 2026, the outstanding principal balance on the 2024 Term Loan was $22.5 million, the stated interest rate was 5.25% and the effective interest rate was 5.43%.
Current wording
The stated interest rate under the 2024 Term Loan is equal to the greater of 1.50% below the Prime Rate or 4.5%. As of September 30, 2026, the outstanding principal balance on the 2024 Term Loan was $22.5 million, the stated interest rate was 5.50% and the effective interest rate was 5.69%.
Previous wording
Under the terms of the 2024 Loan and Security Agreement, we granted Banc of California a security interest in a cash security account at Banc of California (the “Cash Security Account”). We are required to maintain an aggregate unencumbered balance in the Cash Security Account at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Current wording
Under the terms of the 2024 Loan and Security Agreement, we granted Banc of California a security interest in the Cash Security Account. We are required to maintain an aggregate unencumbered balance in the Cash Security Account at least equal to the outstanding principal amount of the 2024 Term Loan then outstanding.
Previous wording
We believe that, as of the date of this Quarterly Report on Form 10-Q, existing cash and cash equivalents, continued fiscal and operating discipline, and availability of our ATM facility will be sufficient to fund our operating expenses, including our PBGENE-HBV and PBGENE-DMD data milestones, and capital expenditure requirements through 2028. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:
Current wording
We believe that, as of the date of this Quarterly Report on Form 10-Q, existing cash and cash equivalents, continued fiscal and operating discipline, and availability of our ATM facility will be sufficient to fund our operating expenses, including our PBGENE-HBV and PBGENE-DMD clinical data milestones, and capital expenditure requirements through 2028. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:
Previous wording
Our critical accounting policies and estimates are described in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K. We have reviewed those critical accounting policies and estimates for the six months ended June 30, 2026. There have been no significant changes in our critical accounting policies and estimates from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Current wording
Our critical accounting policies and estimates are described in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our Annual Report on Form 10-K. We have reviewed those critical accounting policies and estimates for the nine months ended September 30, 2026. There have been no significant changes in our critical accounting policies and estimates from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
Administration (“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.
Current report — wording carried from elsewhere
Azer-cel data presented at the 2026 American Society of Clinical Oncology 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. In October 2026, Imugene reported two further responses, including one complete response in cohort 2 (CAR T naïve) and one partial response in cohort 3 (BTKi combination), bringing the overall response rate to 81% in cohort 2 and 86% in cohort 3.
Current report — wording carried from elsewhere
Gain (Loss) on Disposal of Assets
Current report — wording carried from elsewhere
Gain (Loss) on Disposal of Assets